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Capsella (Capsella bursa-pastoris)

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Authorisation details
Latin name of the genus: Capsella
Latin name of herbal substance: Bursae pastoris herba
Botanical name of plant: Capsella bursa-pastoris (L.) Medikus
English common name of herbal substance: Shepherds Purse
Status: P: Draft published
Date added to the inventory: 31/10/2007
Date added to priority list: 06/03/2008
Outcome of European Assessment: Community herbal monograph
Additional Information:






Product Characteristics - Assessment Report
Table of contents
Assessment report on Capsella bursa-pastoris (L.) Medikus, herba
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1. Introduction
1.1. Description of the herbal substance(s), herbal preparation(s) or
combinations thereof
Herbal substance(s)
Capsella bursa-pastoris (Fam. Brassicaceae/Cruciferae ) is a common cosmopolitan weed growing up to
40 cm and indigenous to Europe, West Africa and Asia. The Latin and common names are derived from
the (shepherd’s) purse shape of the plant’s seed pods. Common names are: shepherd’s purse
(English), bourse à pasteur (French), herderstasje (Dutch), Hirtentäschelkraut (German), bolsa de
pastor (Spanish).
For Capsella herba there is no Ph. Eur. monograph available. Therefore the monographs of the British
Herbal Pharmacopoeia 1996 (BHP), the French Pharmacopoeia (Fr. Ph) and the Complete German
Commission E have been consulted (BHP 1996; Blumenthal, 1998).
The BHP monograph describes Capsella as the dried, aerial parts of Capsella bursa-pastoris
(L.)Medikus and includes macroscopic and microscopic characteristics (including weak, rather
unpleasant odour and slightly saline and astringent taste) (BHP 1996). The description in the French
Pharmacopoeia is: La partie utilisée de la bourse à pasteur est constituée par les parties aériennes
fleuries et fructifères, séchées, de Capsella bursa-pastoris (L.) Medikus récoltées en fin de floraison et
en cours de fructification (Fr. Ph., 1997).
Capsella herba (Bursae pastoris herba) consists of the fresh or dried, above-ground parts of Capsella
bursa-pastoris (L.) Medikus (synonym: Thlaspi bursa-pastoris L.) as well as its preparations in effective
dosage (Blumenthal, 1998).
There is no monograph for Capsella herba included in the ‘WHO monographs on Selected Medicinal
Plants’.
Constituents (Felter, 1922 ; BHP, 1983 ; van Hellemont, 1988; Maillard et al., 1988; Wichtl, 1994;
Khare, 2007; Barnes et al., 2007; Song et al., 2007):
Flavonoids (a.o. flavonglycosides): quercetin, tricin, diosmetin, kaempferol, luteolin, hesperitin
and derivated glycosides (e.g. rutin, diosmin, hesperidin, luteolin-7-rutinoside, luteolin-7-
galactoside, quercetin-3-rutinoside).
Amines: choline (1%) , acetylcholine, histamine
Aminoacids (22, a.o. proline, tyramine, and ornithine), (poly)peptides (a.o. α- and γ-
aminobutyric acid, α-aminoadipic acid) and proteins
Aliphatic and phenolic acids: chlorogenic, vanilic, syringic, fumaric acid
Volatile oil, with at least 74 components identified, with camphor as major constituent
(0.02%).
Resin
Saponins
Other constituents: 9-methylsulfinylnoyl and 10-methylsulfinyldecyl glucosinulates (in seeds),
carotenoids, ascorbic acid, vitamin K, cardenolide, calcium and potassium salts, unidentified
alkaloids, mustardoil glucoside (e.g. sinigrin, possibly responsible for the off-flavours in dairy
products,). Examination of annual crucifers revealed that the concentration of sinigrin in
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Capsella bursa-pastoris is lower than that of mustard oil glycosides in other cruciferous plants
(Park, 1967). See also II.3.3 Overview of available toxicological data.
From a study on the nutritional composition of wild edible crucifer species, a relatively high quantity of
fatty acids ω6-PUFAS was found in Capsella. The amount of erudic acid (C22:1ω9), a fatty acid present
in plant oils of species of Crucifera, known as toxic acid involved in the development of myocarditis,
appeared to be very low (Guil-Guerrero et al., 1999).
In a joint study of Universities of Jordan and Pakistan results of chemical analysis of aerial parts of
Capsella bursa-pastoris revealed the components cupressoflavone (in chloroform phase) and swertisin
(in aqueous phase) (Al-Khalil et al., 2000).
A benzene extract of the aerial parts of Capsella bursa-pastoris was fractionated into seven fractions:
polar lipids (34.7%), free fatty acids, triterpenols (25.8%), diacylglycerols, waxy esters (12.8%),
sterols, chlorophylls (12.4%), triacylglycerols (6.7%), unidentified compounds (4.1%) and
hydrocarbons (3.5%) (Bekker et al., 2002).
A quaternary ammonium salt has been isolated from the herb which is reported to be responsible for
its activity (Kuroda 1968; Khare, 2007).
Young leaves contain Vitamin A (5,000 IU/100 g) and ascorbic acid (91 mg/100 g) (Khare, 2007).
Relatively high quantities of minerals in Capsella have been reported, however low % of Na content
(Guil-Guerrero et al., 1999).
Analysis of herbs and their decoctums and tinctures by ICP-OES revealed that Capsella contains
essential elements as Ca, Cu, Cr, Fe, K, Mg, Mn, Na and Zn, of which some in relatively high amounts
(Ca, Cr, K and Na) compared to the other 9 analysed plant species (Szentmihalyi et al., 2005).
However results of analysis should cautiously be interpreted: Capsella appeared to be a potential
useful biomonitor of the four heavy metals studied (Pb, Cd, Zn and Cu) for monitoring polluted urban
areas (Aksoy, 1999).
Assessor’s comment:
Data on the cardenolide and sinigrin content of Capsella bursa-pastoris is lacking.
Combinations of herbal substance(s) and/or herbal preparation(s)
BHP (1983) mentions the combined use with Trillium and Hydrastis in menorrhagia or metrorrhagia
and combined use with Agothosma in cystitis . In BHP (1996) only the anti-haemorrhagic action is
mentioned.
Capsella herba is used in combinations with many other herbal substances / herbal preparations,
mainly to be used as infusion. Combinations with other herbs have been mentioned in teas to be used
for symptoms in cardiovascular conditions (Wichtl, 1994).
Capsella is marketed in combination with other herbs (e.g Achillea, Majorana and Quercus ) in health
products to regulate menstruation and in urological products (drops and tablets) (Wichtl, 1994). In
Canada Capsella is an approved active ingredient in nearly 20 Schedule OTC Traditional Herbal
Medicines (Wichtl, 1994). Actual market information on Capsella containing medicinal products with a
marketing authorisation or registration is given in next paragraph.
The monograph exclusively refers to Capsella herba.
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1.2. Information about products on the market in the Member States
Capsella herba in medicinal products
From the requests for information to all Member States most agencies responded that there are no
authorised or registered medicinal products containing Capsella on their market. Germany reported
two Marketing Authorisations for herbal teas with Capsella as single active ingredient and in both
Germany and Hungary Capsella is on the market in combination products to be used for tea
preparation (Traditional Use). See also Regulatory Status Overview.
Country Productinformation
Therapeutic
indication
Dosaging
On market
since
Germany WEU: 2 Standard Marketing
Authorisations for herbal teas with
Capsella as single active ingredient
TU: 1 combination product for tea
preparation
Symptomatic
treatment of mild
menorrhagia and
metrorrhagia
(conform
Commission E)
Hungary Herbal tea: per sachet: 0,210 g
Matricaria flos, 0,175 g Millefoli
herba, 0,175 g Bursae pastoris
herba, 0,140 g Foeniculi dulcis
fructis
Symptoms prior
to menstruation;
due to its
components
having
spasmolytic,
antiphlogistic and
anti-dyspeptic
effects, the
herbal tea
relieves the
sensation of
bloating
Starting 3-5
days before
the
menstruation
and should be
applied
during the
whole
menstrual
cycle. 3-5x2-
3 sachets as
an infusion
prepared with
3-5 dl hot
water
(infusion
time: 5-10
minutes)
23-03-2006
There are many Capsella containing preparations on the market as (un)licensed health products under
Food Law. For these preparations no published data has been documented, which could be supportive
evidence on tradition, indication or posology.
A single-ingredient preparation Styptysat, a dry extract (4,1:1; solvent water) of Capsella herba, is on
the market in Germany (Wichtl, 1994; Martindale, 2009).
Fenneherb Cystaid is another multi-ingredient preparation on the UK market (Barnes et al., 2007).
Martindale includes:
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Austria: Menodoron;
France: Hemoluol 1 , Histo-Fluine P, Tisane Provencale no 3, Tisanes de lÁbbe Hamon no 14
Germany: Bilisan forte, Bomagall forteS, Dr. Klingers Bergischer Krautertee,
Leber-und Gallentee, Duoform, Gallitophen, Menodoron, Menstrualin, Original-Hico-Gallenheil,
Presselin Dysmen Olin 3 N, Rhoival, Rowaclimax
Poland: Klimax, Prostapol, Uroprost
Spain: Proctosor
United Kingdom : Antitis, Sciargo (Martindale, 2009).
Regulatory status overview
Member State Regulatory Status
Comments (not
mandatory field)
Austria
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Belgium
MA
TRAD
Other TRAD
Other Specify:
Bulgaria
MA
TRAD
Other TRAD
Other Specify: No products with MA; no
info on food
supplements
Cyprus
MA
TRAD
Other TRAD
Other Specify:
Czech Republic
MA
TRAD
Other TRAD
Other Specify:
Denmark
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Estonia
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Finland
MA
TRAD
Other TRAD
Other Specify:
France
MA
TRAD
Other TRAD
Other Specify: Only in combination
products (2 WEU-
products containing
herbals + chemical
component; 1 TU -
product containing only
herbals)
Germany
MA
TRAD
Other TRAD
Other Specify: WEU: 2 herbal teas with
Capsella as single
ingredient
TU: 1 combination
product for tea
preparation
Greece
MA
TRAD
Other TRAD
Other Specify:
Hungary
MA
TRAD
Other TRAD
Other Specify: 1 combination product
for tea preparation as
THMP, 1 herbal tea with
Capsella as single
ingredient on market as
food
1 This preparation is discontinued or no longer marketed
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Member State Regulatory Status
Comments (not
mandatory field)
Iceland
MA
TRAD
Other TRAD
Other Specify:
Ireland
MA
TRAD
Other TRAD
Other Specify:
Italy
MA
TRAD
Other TRAD
Other Specify:
Latvia
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Liechtenstein
MA
TRAD
Other TRAD
Other Specify:
Lithuania
MA
TRAD
Other TRAD
Other Specify:
Luxemburg
MA
TRAD
Other TRAD
Other Specify:
Malta
MA
TRAD
Other TRAD
Other Specify:
The Netherlands
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Norway
MA
TRAD
Other TRAD
Other Specify:
Poland
MA
TRAD
Other TRAD
Other Specify:
Portugal
MA
TRAD
Other TRAD
Other Specify:
Romania
MA
TRAD
Other TRAD
Other Specify:
Slovak Republic
MA
TRAD
Other TRAD
Other Specify: No medicinal products
on market with Capsella
Slovenia
MA
TRAD
Other TRAD
Other Specify:
Spain
MA
TRAD
Other TRAD
Other Specify: Only in combination
products
Sweden
MA
TRAD
Other TRAD
Other Specify:
United Kingdom
MA
TRAD
Other TRAD
Other Specify: Only in combination
products
MA: Marketing Authorisation
TRAD: Traditional Use Registration
Other TRAD: Other national Traditional systems of registration
Other: If known, it should be specified or otherwise add ’Not Known’
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the
products in the MSs concerned.
1.3. Search and assessment methodology
Databases assessed (date, search terms) and other sources used.
If applicable (data availability), inclusion and exclusion criteria for
literature, ideally differentiated between the main topics Non-
clinical, Clinical, Safety.
Cross-reference to the list of references in Annex, which should list
separately the references supporting the assessment report and the
references used but which do not support the assessment report.
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2. Historical data on medicinal use
2.1. Information on period of medicinal use in the Community
European tradition
Steinmetz (1954) mentions that an infusion of Capsella is cooling, diuretic and astringent and therefore
beneficial in all kinds of blood and bladder problem s (diarrhea with sharp and bloody stools, piles,
profuse menses, dropsy, diseases of bladder, spitting of blood). Extractum Capsellae Bursae pastoris
liquidum is used as a substitute for ergot of rye to arrest bleeding from lungs, stomach, uterus and
kidneys. Steinmetz addressed the considerable haemostatic action to the fungi Cystopus Candidus and
Peronospora Grisea, which would grow on the plant and produce the odour of trimethylamine. Also
Wichtl (1994) mentions the former common use of Capsella as a substitute for ergot in uterine
hemorrhaging, and its continuous use in folk medicine to treat dysmenorrhea. Van Hellemont states
that both ergot and Capsella are useful in meno- and metrorrhagia, but ergot would perform a stronger
haemostyptic activity (Van Hellemont, 1988).
According to Wichtl (1994) Capsella is still occasionally used in traditional medicine as a styptic remedy
(its former common use as a substitute for ergot in uterine haemorhaging is obsolete). It is used in
European traditional medicine for preventing or arresting hemorrhage, more specifically to treat
dysmenorrhea.
Asian tradition
In Tibetan medicine Capsella is used to stop vomiting, to treat kidneys, lungs, and nerve disorders and
fluid retention of the body (Wichtl 1994). Capsella is used in Indian medicine in menorrhagia and
hemorrhages from renal and genito-urinary tract, in diarrhoea and dysentery and as a diuretic (Khare,
2007).
In China a decoction of the whole plant is used in hypertension and as hemostatic agent for treatment
of chyluria (fat globules in the urine) and hematuria (Herbalgram, 2008).
For each herbal preparation, provide evidence of history and extent of use preferably classified
whether predominantly European or non-European tradition, and the more recent/current use.
2.2. Information on traditional/current indications and specified
substances/preparations
The following indications have been reported for Capsella bursa pastoris :
Blood/Hemorrhages/Bleeding
reference
indication
preparation
Felter, 1922
Passive hemorrhages (and slight
stimulant in amenorrhoea)
- Specific Medicine Capsella
Infusum Capsella
Steinmetz, 1954
Hemostatic agent for all kind of
bleedings
- Infusion
- Extractum Capsella Bursae pastoris
liquidum
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BHP 1983
Anti-hemorrhagic
- Infusion
- Liquid Extract 1:1 in 25% alcohol
Van Hellemont, 1988 Blood pressure lowering
- Herba bursae pastoris as infusion
- Extractum bursae pastoris
- Tinctura bursae pastoris Rademacher
- Capsella bursae pastoris Mother
Tincture (M.T.(ø))
- Extractum fluidum bursae pastoris
Van Hellemont, 1988 Bleeding wounds (topical use)
Ointment or tincture
Blumenthal, 1998
Nosebleeds and superficial
bleeding skin injuries
(local/external application)
- Infusion
- Fluidextract (acc. to Erg. B. 6)
KNMP, 1990
Hemostatic agent (menstrual and
nose bleedings)
- Infusion
- Thlaspi bursae-pastoris ø
(1:2 fresh whole plant in 50 %
alcohol v/v)
Wichtl, 1994
As hemostatic agent
- Infusion
- Dry extract (DER 4.1:1; solvent
water)
Barnes et al., 2007 Anti-hemorrhagic (traditionally
used for hematemesis, hematuria)
- Infusion
- Liquid extract (1:1 in 25% alcohol)
Menorrhagia / Metrorrhagia
reference
indication
preparation
Felter, 1922
Prolonged and oft-occurring
menorrhagia with too long, too
frequent, almost colourless flow
- Specific Medicine Capsella
Infusum Capsella
Steinmetz, 1954
Profuse menses
- Infusion
- Extractum Capsella Bursae pastoris
liquidum
BHP 1983
Uterine hemorrhage, menorrhagia,
hematestatis, hematuria, (in
combination with Trillium and
Hydrastis)
- Infusion
- Liquid Extract 1:1 in 25% alcohol
Van Hellemont, 1988 Hemostypticum in menorrhagia
and metrorrhagia
- Herba bursae pastoris as infusion
- Extractum bursae pastoris
- Tinctura bursae pastoris Rademacher
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- Capsella bursae pastoris M.T.(ø)
- Extractum fluidum bursae pastoris
Wichtl, 1994
Dysmenorrhea
- Infusion
- Dry extract (DER 4.1:1; solvent
water)
Mc Guffin, 1997
As emmenagogue/uterine
stimulant
Blumenthal, 1998;
Schulz et al., 1998
Symptomatic treatment of mild
menorrhagia and metrorrhagia
- Infusion
- Fluidextract (acc. to Erg. B. 6)
Barnes et al., 2007 menorrhagia
- Infusion
- Liquid extract (1:1 in 25% alcohol)
Khare, 2007
menorrhagia
- Juice extracts
Urinary tract and intestines
reference
indication
preparation
Felter, 1922
Irritation of urinary organs with
phosphatic deposits, atonic
disorders with constant desire to
urinate
- Specific Medicine Capsella
Infusum Capsella
Steinmetz, 1954
- Infusion
- Extractum Capsella Bursae pastoris
liquidum
BHP 1983
(Acute catarrhal) cystitis, as
urinary antiseptic (in combination
with Agathosma)
- Infusion
- Liquid Extract 1:1 in 25% alcohol
Barnes et al., 2007 Urinary antiseptic, diarrhoea and
acute catarrhal cystitis
- Infusion
- Liquid extract (1:1 in 25% alcohol)
Khare, 2007
Haemorrhages from renal and
genitourinary tract, diarrhoea and
dysentery
- Juice extracts
Documented medicinal uses:
Based on above mentioned references Capsella herba is considered to be a traditional herbal medicinal
product for use in the specified indications exclusively based upon long-standing use:
as anti haemorrhagic in all kinds of bleedings, including skin injuries and nosebleeds (oral and
topical use)
for symptomatical treatment of mild menorrhagia and metrorrhagia
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Assessor’s comment:
Due to the lack of sufficient data to support the traditional use (i.e. no information on the extent and
duration of use and/or defined posology) as antiseptic agent in diarrhea and cystitis and as blood
pressure lowering agent, these uses have not been included into the monograph.
The treatment of nosebleed and bleeding due to skin injuries is also not included in the monograph
because for these indications a tea preparation is used. The tea preparation and the cooling of the tea
would take at least 30 minutes. During this time bleeding should already have stopped.
2.3. Specified strength/posology/route of administration/duration of use
for relevant preparations and indications
Posology for adolescents and adults:
Herbal substance and comminuted herbal substance for tea preparation for oral use :
reference
single dose per
150 ml of water
daily dose
indication
BHP, 1983;
Barnes et al., 2007
1-4 g
3-12 g
Menorrhagia, haematemesis,
haematuria, uterine
haemorrhage, diarrhoea and
acute catarrhal cystitis
Van Hellemont, 1988 5 g
10-20 g
Hemostypticum in menorrhagia
and metrorrhagia; blood
pressure lowering
KNMP, 1990
2,5 -5g
5-20 g
Haemostatic agent (menstrual
and nose bleedings)
Wichtl, 1994
3-5 g
up to 15 g
As haemostatic agent,
dysmenorrhea
Blumenthal, 1998
10-15 g
equivalent
preparations
Symptomatic treatment of mild
menorrhagia and metrorrhagia
Schulz et al., 1998
5-15 g
Symptomatic treatment of mild
menorrhagia and metrorrhagia
Herbal substance and comminuted herbal substance for tea preparation for topical use (poultice or
nasal dressing):
reference
single dose per
150 ml of water
daily dose
indication
Wichtl , 1994;
Blumenthal, 1998
3-5 g per ¾ of water dose freely
As haemostatic agent;
nosebleeds and superficial
bleeding skin injuries
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Herbal preparation: Liquid extract 1:1 in 25% alcohol
reference
single dose
daily dose
indication
BHP, 1983;
Barnes et al., 2007
1-4 ml
3-12 ml
Menorrhagia, haematemesis,
haematuria, diarrhea and acute
catarrhal cystitis
Herbal preparation: Liquid extract (acc. to Erg. B. 6) 2 for oral use
reference
single dose
daily dose
indication
Wichtl, 1994;
Blumenthal, 1998
5-8 g
Symptomatic treatment of mild
menorrhagia and metrorrhagia,
as haemostatic agent,
dysmenorrhea
Herbal preparation: Liquid extract (acc. to Erg. B. 6) for topical use
reference
single dose
daily dose
indication
Blumenthal, 1998;
Herbalgram, 2008
5-8 g
- nosebleeds and superficial
skin wounds and bruising
Posology for children (information from: ’Heilpflanzen in der Kinderheilkunde’ (Bühring et al., 2007)
Herbal substance and comminuted herbal substance for tea preparation for oral use :
age in years
daily dose
0 -1
-
1 - 4
-
4 - 10
-
10 - 16
10 – 15 g
Herbal substance and comminuted herbal substance for preparation of infusion for topical use (poultice
or nasal dressing)
age in years
daily dose
0 - 1
-
1 - 4
2 – 3.5 g/150 ml
4 - 10
2 – 3.5 g/150 ml
10 - 16
3 - 5 g/150 ml
2 Ergänzungsbuch zum DAB 6 (1941)
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Assessor’s comment:
The use of Capsella in children is described in only one reference, the duration of experience with
medicinal use in children is unknown. Furthermore (pre-) clinical data to support the safe use in
children is lacking. Therefore the use in children is not included in the monograph.
Other preparations
In the consulted documentation following preparations have been mentioned, but due to lack of
information, (either the herbal preparation is not clearly specified, and/or the posology has not been
documented) these cannot be included into the monograph.
preparation
single dose
daily dose
reference
Acidum bursinicum
Bombelon, 1888
(in Kuroda 1969)
Specific Medicine Capsella
1-60 drops
Felter, 1922
Infusion (of fresh herb, 3j to
water 0j)
dosing freely
Felter, 1922
Extractum Capsella Bursae
pastoris liquidum
Steinmetz, 1954
Extractum bursa-pastoris
2 g
2-3 times daily
Van Hellemont, 1988
Tinctura bursa-pastoris
Rademacher (from fresh herb)
20-40 drops
several times daily Van Hellemont, 1988
Extractum fluidum bursa-
pastoris
5-15 g daily or 1
teaspoon
2-4 times daily
Van Hellemont, 1988
Thlaspi bursae-pastoris ø
(1:2 fresh whole plant in 50%
alcohol v/v)
KNMP, 1990
Dry extract
(DER 4,1: 1; water)
Wichtl, 1994
Juice extracts
Barnes et al., 2007;
Khare, 2007
Conlusion
Oral administration and topical application are the routes of administration for Capsella herba
preparations in the recommended traditional indications. From the information in the handbooks the
following posology data for the specified preparations can be concluded.
Proposed posology for adults (tea for oral use)
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Indication: symptomatic treatment in menorrhagia and metrorrhagia
single dose
daily dose
A) Herbal substance and comminuted
herbal substance for tea preparation
1-5 g
3-20 g
B) Liquid extract 1:1 in 25% alcohol 1-4 ml
3-12 ml
C) Liquid extract (acc. to Erg. B. 6)
5-8 g
Assessor’s comment:
No restriction on the duration of use has been reported for Capsella herba.
The remark should be added that if the symptoms persist during the use of the medicinal product, a
doctor or a qualified health care practitioner should be consulted.
2.4. Assessor’s overall conclusion on the historical data on medicinal use
Historical data on the medicinal use of Capsella herba is predominantly based on the use of Capsella
herb as infusion, to a lesser extent to other preparations. Of all mentioned preparations few are well
specified and defined and lack data on posology. For acceptance in the monograph, the traditional use
of the individual preparations based on Capsella should be evaluated:
The use Capsella herba as an infusion for the treatment of haemorrhages has been reported at
least since 1922 and can be accepted according to the 30 years of use in medicinal practice in
Europe. Many handbooks have published information on the use of this infusion, including dosages
for both oral and topical application. In Germany Capsella herbal substance is still on the market
both as a single ingredient and in combination products for tea preparation.
The use Capsella herba liquid extract (1:1 in 25% alcohol) for the treatment of
haemorrhages/bleedings has been reported at least since 1983 and can therefore be accepted
according to the 30 years of use in medicinal practice in Europe. Several handbooks mention the
use and dosage of this liquid extract, therefore this extract can be included into the monograph.
The use of Capsella herba as a liquid extract (acc. to Erg. B.6) for the treatment of
haemorrhages/bleeding has been reported in handbooks at least since 1941 (Ergänzungsbuch zum
DAB, 1941 as mentioned in Blumenthal 1998 and Wichtl 1994). This preparation is not included in
the monograph because a clear manufacturing method and posology are lacking.
3. Non-Clinical Data
3.1. Overview of available pharmacological data regarding the herbal
substance(s), herbal preparation(s) and relevant constituents thereof
In vitro studies with Capsella (preparations)
Studies with an ethanolic Capsella extract exhibited
Anti-inflammatory activity versus carrageenan-induced and dextran-induced rat paw oedema
(Barnes et al.; Kuroda & Tagaki, 1969).
A reduction in capillary permeability in the guinea-pig induced by histamine and serotonin (Barnes
et al.; Kuroda & Tagaki, 1969).
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A purified substance from the alcohol extract exerted contractile activity on rat uterus equivalent to
that of oxytocin (0.1 i.u), which was unaffected by atropine but inhibited by competitive inhibitors
of oxytocin (substance had some characteristics of a polypeptide) (Kuroda & Tagaki, 1968).
Studies on the isolated heart have reported negative chronotropic and inotropic actions in the guinea-
pig and rabbit and coronary vasodilatation (Barnes et al.; Jurisson, 1971).
Weak antibacterial activity mainly towards Gram-positive organisms has been reported (Barnes et al.;
Moskalenko, 1986).
The extract of dried or fresh plant material causes strong contraction of the uterus and small intestine s
of guinea-pigs, unaffected by atropine and diphenhydramine, but inhibited by papaverine
(Barnes et al.; Kuroda & Tagaki 1968; Jurisson, 1971; Khare, 2007).
Antioxidant activity of a methanolic extract form Capsella aerial parts was demonstrated in vitro , which
might be due the high total phenolic content (Heo et al., 2007).
In vitro studies with isolated components of Capsella
Two unidentified alkaloid components of Capsella have been stated to elicit a physiological activity on
the uterus (Barnes et al.; Kuroda & Kaku 1969).
Flavonoid components isolated from Capsella have been reported to reduce blood vessel permeability
in mice (Barnes et al.; Jurisson, 1973).
Antineoplastic acitvity in rats has been reported for fumaric acid, which prevented the development of
hepatic neoplasms when co-administered with the carcinogen 3-MeDAB (Barnes et al.; Kuroda, 1977).
In vivo studies
After oral or intraperitoneal administration of Capsella in mice diuresis has been reported; the mode of
action was stated to involve an increase in the glomerular filtration rate
(Barnes et al.; Kuroda & Tagaki, 1969).
A transient decrease of bloodpressure was observed after intravenous administration of an ethanolic
extract of Capsella to various kinds of animals (dogs, cats, rabbits, rats); the decreasing activity was
antagonised by a β-adrenoreceptor blocker but not by atropine. The authors concluded that this action
could not be attributable to other than cholinergic compounds (Kuroda & Kaku, 1969).
Following intra-arterial administration of Capsella extract increased coronary blood flow has been
reported in dogs and a slight inhibitory effect on ouabain-induced ventricular fibrillation in the rat
together with a chronotropic effect after intraperitoneal injection (Barnes et al.; Jurisson, 1971).
By Capsella induced tracheal contractions in the guinea-pig were unaffected by adrenaline, which did
inhibit acetylcholine induced contractions (Barnes et al.; Jurisson, 1971).
A CNS-depressant action in mice has been demonstrated (potentiation of barbiturate-induced sleeping
time) (Barnes et al.; Jurisson, 1971).
After parenteral application muscarine-like effects have been reported with dose-dependant lowering
and elevation of bloodpressur e, positive inotropic and chronotropic cardiac effect , and increased
uterine contraction (Blumenthal, 1998).
Intraperitoneal injections of an ethanolic extract of Capsella (0.14 g/kg/day) exhibited an inhibitory
effect on Ehrlich solid tumor in mice; treatment with the isolated compound fumaric acid showed this
same activity (Kuroda et al., 1976).
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From the results of in vitro and animal studies it was concluded that the active substance(s)
responsible for the observed actions by Capsella on smooth muscle were neither acetylcholine nor
histamine (Barnes et al.; Kuroda & Tagaki 1968; Jurisson, 1971).
Assessor’s comment:
Most of the cited articles contain very little data on study details; supportive studies on haemostatic
activity are lacking.
3.2. Overview of available pharmacokinetic data regarding the herbal
substance(s), herbal preparation(s) and relevant constituents thereof
No data with regard to absorption, distribution, metabolism, elimination, pharmacokinetic interactions
with other medicinal products are available.
3.3. Overview of available toxicological data regarding the herbal
substance(s)/herbal preparation(s) and constituents thereof
Acute toxicity
Capsella extracts have been reported to exhibit low toxicity in mice. Signs of toxicity were described as
sedation, enlargement of pupils, paralysis of hind limbs, difficulty in respiration, and death by
respiratory paralysis. LD50 values reported are 1.5 g/kg body weight (mice, intraperitoneal injection)
and 31.5 g/kg bodyweight (mice, subcutaneous injection) (Barnes et al.; Jurisson, 1971).
Sinigrin
Following hydrolysis catalysed by the plant enzyme, myrosinase, the constituent sinigrin yields
allylisothiocyanate, a powerfull irritant agent producing blisters on the skin. Isothiocyanates have been
implicated in endemic goitre (hypothyroidism with thyroid enlargement) and have been reported to
produce goitre in experimental animals (Barnes et al.; G41- Leung, 1980).
Assessor’s comment:
No data on glucosinolate content or more specifically sinigrin content have been found. Not only total
glucosinolate levels, but also glucosinolate composition may differ considerably between species, plants
and even different tissues within the same plant (Hopkins, 2009). Sabri et al., (1975) report that the
flowers of Capsella contain most sinigrin.
The metabolism of sinigrin in the human body is probably more complex. In a dynamic in vitro large-
intestinal model the production of allyl isothiocyanate from sinigrin was investigated after inoculation
with a complex microflora of human origin. As only a small part (mean 19%) of sinigrin was converted
into allyl isothiocyanate, it was suggested that allyl isothiocyanate is converted further into other, yet
unknown, metabolites (Krul et al., 2002).
Isothiocyanate can be further degraded to produce the thiocyanate ion. This component is able to
cause goitre in humans when dietary iodine is insufficient. However there is no evidence to support a
causative role for dietary glucosinolates in human goitre (NZFSA, 2010).
The International Agency for Research on Cancer (IARC) reports that there is inadequate evidence in
humans for the carcinogenicity of allyl isothiocyanate and limited evidence in experimental animals for
the carcinogenicity of allyl isothiocyanate (IARC, 1999).
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Safety of glucosinolates in the human diet has not been assessed by any national or international
organisation as reported by the NZFSA (2010).
In relation to the above mentioned, the presence of glucosinulates in Capsella preparations which are
administered in small quantities for a limited duration of time is considered not to be a concern of
safety.
No data with regard to repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and
developmental toxicity, local tolerance, or other special studies are available.
3.4. Overall conclusions on non-clinical data
Studies on haemostatic activity have not been found. In vitro and in vivo studies with Capsella
preparations or ingredients demonstrate potential anti-inflammatory, antioxidant, antibacterial activity,
reduction of blood vessel permeability and stimulating activity on diverse smooth tissues.
There are limited toxicological preclinical data.
Capsella extracts showed low toxicity in mice (IP injection LD50: 1.5 g/kg, subcutaneous injection
LD50: 31.5 g/kg).
4. Clinical Data
No clinical data available.
4.1. Clinical Pharmacology
4.1.1. Overview of pharmacodynamic data regarding the herbal
substance(s)/preparation(s) including data on relevant constituents
No clinical data available.
4.1.2. Overview of pharmacokinetic data regarding the herbal
substance(s)/preparation(s) including data on relevant constituents
No clinical data available.
4.2. Clinical Efficacy
No clinical data available.
4.2.1. Dose response studies
No clinical data available.
4.2.2. Clinical studies (case studies and clinical trials)
No clinical data available.
4.2.3. Clinical studies in special populations (e.g. elderly and children)
No clinical data available.
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4.3. Overall conclusions on clinical pharmacology and efficacy
The plausibility of efficacy for the specific indications of Capsella bursa-pastoris herb in the context of
reduction of bleeding cannot be further substantiated by clinical data, as they are not available.
5. Clinical Safety/Pharmacovigilance
5.1. Overview of toxicological/safety data from clinical trials in humans
No clinical data available.
5.2. Patient exposure
No experimental data in humans is available.
From marketing experience data received from the Member States no pharmacovigilance actions have
been undertaken and none have been reported following the use of Capsella preparations (based on
data received from 12 Member States, situation on 17 August 2010).
5.3. Adverse events and serious adverse events and deaths
No clinical data available.
5.4. Laboratory findings
No clinical data available.
5.5. Safety in special populations and situations
As no explicit data have been found on intrinsic/extrinsic factors, drug interactions, use in pregnancy
and lactation, overdose, drug abuse, withdrawal and rebound, effects on ability to drive or operate
machinery or impairment of mental ability, following has to be taken into consideration:
The use of Capsella cannot be recommended during pregnancy and lactation , as reproductive toxicity
data are missing.
No safety data have been found on the use of Capsella preparations in children.
The potential for Capsella preparations to interact with other medicines administered
concomitantly/concurrently should be considered, especially those with similar or opposing effects
(Barnes et al., 2007).
There is limited evidence from preclinical studies that Capsella herba and/or certain isolated
constituents may have hypotensive, diuretic and cardiac activities and effects on thyroid function
(Barnes et al., 2007).
Assessor’s comment:
As these effects have mostly been reported in animals after non-oral administration of isolated
components of Capsella and mechanisms of action are still unknown, the relevance of these data to
human use remains unclear.
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The Botanical Safety Handbook mentions the emmenagogue and uterine stimulating activity of
Capsella, that large doses of extract may cause heart palpitations and that people with a history of
kidney stones should be cautious (McGuffin, 1997).
Assessor’s comment : Causality of above mentioned effects with the use of Capsella is not clear,
severity and frequency are unknown, as references are untraceable/missing. In other handbooks these
safety issues have not been mentioned.
5.6. Overall conclusions on clinical safety
Clinical safety data are very limited. However no safety problems concerning the traditional use of
Capsella bursa-pastoris have been reported.
The use of Capsella should be avoided during pregnancy and lactation, as safety during pregnancy and
lactation has not been established.
The oral use in children under 18 years is not recommended.
6. Overall conclusions
Classification
As clinical studies are missing Capsella herba preparations cannot be considered for well-established
use indications; only Traditional Use (TU) is applicable. Results of well designed randomised clinical
studies will be needed to verify the clinical relevance of the described pharmacological effects.
A list entry is not applicable, because studies on genotoxicity, mutagenic and carcinogenic properties
are lacking.
Safety
No published reports on serious side effects after use of Capsella containing preparations have been
found and no pharmacovigilance issues been reported by Member States marketing Capsella products.
See also 5.2 Patient exposure.
No experimental data is available on possible toxicity of (preparations of) Capsella bursa-pastoris .
However, in view of the results of the preclinical studies and the long period of marketing experience
without reports of adverse reactions, the specified Capsella bursa-pastoris herbal preparations can be
considered as proven not to be harmful in the specified conditions of use as required by Art. 16a 1 (e)
of Directive 2004/24/EC.
Some special warnings are stated in the Botanical Safety Handbook:
Individuals with a history of kidney stones should be cautiously
Large doses of extract may cause heart palpitations (Mc Guffin, 1997).
However as justifying data on clinical relevance are lacking and as these warnings are not mentioned
in other handbooks, it is expected that the recommended use is safe. Therefore these warnings will not
be included in the monograph.
Use
The long traditional experience in bleeding and many other health problems, support the safe use of
the specified herbal preparations in the context of reduction of bleeding.
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Capsella herba is used for the reduction of heavy menstrual bleeding in women with regular menstrual
cycles.
The pharmacological effects or efficacy are only plausible on basis of long-standing use and
experience, as required by Art 16a 1 (e) of Directive 2004/24/EC and are not supported by
pharmacological data.
Posology
Adults and elderly
Children and adolescents
Oral use
Oral use
Comminuted herbal substance as tea:
1-5 g as a single dose,
2-4 times daily (daily dosage: 3-20 g)
The oral use in children and adolescents under
18 years of age is not recommended (see
section 4.4 ‘Special warnings and precautions for
use’).
Liquid extract: (DER 1:1), extraction solvent
ethanol 25% V/V: 1-4 ml 3 times daily
Duration of use
Oral use
If heavy menstrual bleeding is not reduced after 3 cycles, a doctor should be consulted.
Monograph
The monograph for Capsella herba will be based on the Capsella herbal substance to be used in above
mentioned liquid dosage forms only for oral use. (other preparations may be added, when clear
specifications, study data and/or more market information will be made available).
Annex
List of references
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Source: European Medicines Agency



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