Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver

NCT00794690 | Completed

• 1 other identifier: CR and the liver
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. The investigators are trying to verify or refute such allegations.

Conditions

Menopause

Keywords

cimicifuga racemosa; liver blood flow and functions

Outcome Measures

Primary Outcomes (1)

• Effect on hepatic perfusion and liver functions

  12 months

Secondary Outcomes (1)

• Efficacy and tolerability

  12 months

Study Arms (1)

black cohosh extract, liver

EXPERIMENTAL

100 postmenopausal women

Drug: Cimicifuga racemosa extract for the group

Interventions

Cimicifuga racemosa extract for the group DRUG

40 mg of Cimicifuga racemosa extract daily dor 12 months

Also known as: Klimadynon®

black cohosh extract, liver

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Dept. Obstetrics and Gynecology, Assiut University

Asyut, Asyut Governorate, 71516, Egypt

Location

Related Publications (2)

• 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.

  PMID: 18340277 BACKGROUND

• Chow 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.

  PMID: 18393750 BACKGROUND

MeSH Terms

Interventions

black cohosh root extract; Klimadynon

Study Officials

• AHMED M NASR, MD

  ASSIUT UNIVERSITY, EGYPT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

EG (1)