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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| black cohosh extract, liver | Experimental | 100 postmenopausal women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cimicifuga racemosa extract for the group | Drug | 40 mg of Cimicifuga racemosa extract daily dor 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on hepatic perfusion and liver functions | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and tolerability | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED M NASR, MD | ASSIUT UNIVERSITY, EGYPT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Obstetrics and Gynecology, Assiut University | Asyut | Asyut Governorate | 71516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18340277 | Background | 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. | |
| 18393750 | 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. |
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| ID | Term |
|---|---|
| C000713173 | black cohosh root extract |
| C584106 | Klimadynon |
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