MenopauseCR-LIVERNCT00794690
Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver
A study testing Cimicifuga racemosa extract for the group in people with Menopause, run by Assiut University at 1 site in Egypt.
Trial summary
Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Cimicifuga racemosa extract for the group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- an age over 40 years
- with a lapse of one year after the last menstruation
- symptomatic women without gynecological illness
- after naturally occurring menopause
- had never used hormonal therapy or had stopped using them for >6 months
- accepting to participate after receiving adequate description of the study
- accessible for regular follow-up.
Who cannot join
- vaginal bleeding
- active or chronic liver disease and /or abnormal liver functions
- present or past thromboembolic disease
- present or past neoplasia of the breast or uterus
- an endometrial thickness >5 mm by TVS
- use of alternative or complementary medicines or herbs for menopausal symptoms within the previous three months
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dept. Obstetrics and Gynecology, Assiut University
Asyut, Asyut Governorate, 71516
About this study
Official title: Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.
Read the detailed description
The aim of this prospective longitudinal clinical trial is to evaluate changes in total hepatic blood flow and liver functions among postmenopausal women using black cohosh (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms.
Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa (Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color Doppler ultrasound. Moreover, prothrombin time \& concentration, serum albumin, bilirubin, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will also be measured.
- Conditions
- Menopause
- Being tested
- Cimicifuga racemosa extract for the group
- Keywords
- cimicifuga racemosa, liver blood flow and functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimicifuga racemosa extract for the groupDrug
Also called Klimadynon®
40 mg of Cimicifuga racemosa extract daily dor 12 months
| Study group | Role | What they receive |
|---|---|---|
| black cohosh extract, liver | Experimental | 100 postmenopausal women Receives: Drug: Cimicifuga racemosa extract for the group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on hepatic perfusion and liver functions
Measured: 12 months
Secondary outcomes (1)
Efficacy and tolerability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Investigators
- AHMED M NASR, MD, Principal investigator, ASSIUT UNIVERSITY, EGYPT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794690
- Sponsor's protocol ID
- CR and the liver
- Acronym
- CR-LIVER
- Status last verified
- Jul 2009
- First submitted
- 19 Nov 2008
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, Marles RJ, Pellicore LS, Giancaspro GI, Sarma DN. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause. 2008 Jul-Aug;15(4 Pt 1):628-38. doi: 10.1097/gme.0b013e31816054bf.
PubMed 18340277Chow EC, Teo M, Ring JA, Chen JW. Liver failure associated with the use of black cohosh for menopausal symptoms. Med J Aust. 2008 Apr 7;188(7):420-2. doi: 10.5694/j.1326-5377.2008.tb01691.x. No abstract available.
PubMed 18393750
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Black Cohosh (Cimicifuga Racemosa) Use by Postmenopausal Women on Total Hepatic Perfusion and Liver Functions
- ClinicalTrials.gov ID
- NCT00794690
- Acronym / sponsor ID
- CR-LIVER / CR and the liver
- Conditions
- Menopause
- Keywords
- cimicifuga racemosa, liver blood flow and functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent case reports pointed to potential toxicity of black cohosh on the liver. The investigators are trying to verify or refute such allegations.
Detailed description
The aim of this prospective longitudinal clinical trial is to evaluate changes in total hepatic blood flow and liver functions among postmenopausal women using black cohosh (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms.
Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa (Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color Doppler ultrasound. Moreover, prothrombin time \& concentration, serum albumin, bilirubin, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| black cohosh extract, liver | Experimental | Drug: Cimicifuga racemosa extract for the group100 postmenopausal women |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- an age over 40 years
- with a lapse of one year after the last menstruation
- symptomatic women without gynecological illness
- after naturally occurring menopause
- had never used hormonal therapy or had stopped using them for >6 months
Key exclusion criteria (6 listed)
- vaginal bleeding
- active or chronic liver disease and /or abnormal liver functions
- present or past thromboembolic disease
- present or past neoplasia of the breast or uterus
- an endometrial thickness >5 mm by TVS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cimicifuga racemosa extract for the groupAlso: Klimadynon®40 mg of Cimicifuga racemosa extract daily dor 12 months | Drug | black cohosh extract, liver |
Primary outcome
Effect on hepatic perfusion and liver functions
Time frame: 12 months
1 secondary outcome
Efficacy and tolerability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
- Background: PubMed 18340277Mahady GB, Low Dog T, Barrett ML, Chavez ML, Gardiner P, Ko R, Marles RJ, Pellicore LS, Giancaspro GI, Sarma DN. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause. 2008 Jul-Aug;15(4 Pt 1):628-38. doi: 10.1097/gme.0b013e31816054bf.
- Background: PubMed 18393750Chow EC, Teo M, Ring JA, Chen JW. Liver failure associated with the use of black cohosh for menopausal symptoms. Med J Aust. 2008 Apr 7;188(7):420-2. doi: 10.5694/j.1326-5377.2008.tb01691.x. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED M NASR, MD principal investigator
ASSIUT UNIVERSITY, EGYPT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cimicifuga racemosa extract for the group in people with Menopause, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on hepatic perfusion and liver functions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2009.