China Cimicifuga Trial of Climacteric Complaint Control

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women

Detailed Description
-----------------
Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

Official Title
-----------------
A Multicentered RCT Study of the Efficacy and Safety of an Extract of Cimicifuga Foetida L. for the Treatment of Climacteric Symptoms of Chinese Women

Conditions
-----------------
Climacteric Symptoms

Intervention / Treatment
-----------------
* Drug: an extract of Cimicifuga Foetida L.
* Drug: an extract of Cimicifuga Foetida L.
* Drug: placebo
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having climacteric symptoms with hot flushes >= 3 time per day Score of Kupperman Index at baseline >= 20 In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH > 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH >= 40U/L and E2 <= 30pg/ml, were assigned into early staged postmenopausal group. Exclusion Criteria: Having history of hysterectomy Having HRT within 6 weeks Having other drugs or nutritional supplements of relieving climacteric symptoms within one week Having psychological counseling within one week Having medical history of estrogen-dependent tumors The result of pap smear exam at stage III and above Having an uterine leiomyoma lager than 4 cm The endometrial thickness lager than 0.5 cm Having abnormal cardiac, liver or kidney functions Having abnormal thyroid function Having hypertension, diabetes and coronary heart diseases that were not under control Pregnant or suspected pregnant woman Having severe mental disorders that inhibit to understand the research purpose Other conditions the investigators believed not suitable for enrollment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>perimenopausal women | Drug: an extract of Cimicifuga Foetida L.<br>* Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.<br>* Other names: Ximingting;|
| Placebo Comparator: A2<br>perimenopausal women | Drug: placebo<br>* Each patient will be given placebo of 2 tablets each day for 3 months.<br>|
| Experimental: B1<br>early staged postmenopausal women | Drug: an extract of Cimicifuga Foetida L.<br>* Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.<br>* Other names: Ximingting;|
| Placebo Comparator: B2<br>early staged postmenopausal women | Drug: placebo<br>* Each patient will be given placebo of 2 tablets each day for 3 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of scores of Kupperman Index before and after the treatment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of scores of Menopause Rating Scale before and after the treatment |  | 3 months |