China Cimicifuga Trial of Climacteric Complaint Control - Full Text View

Sponsored by:	Shandong Luye Pharmaceutical Co., Ltd.
Information provided by:	Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00622986

Purpose

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

Condition	Intervention	Phase
Climacteric Symptoms	Drug: an extract of Cimicifuga Foetida L. Drug: placebo	Phase IV

Drug Information available for: Cimicifuga

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment
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

Further study details as provided by Shandong Luye Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Change of scores of Kupperman Index before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of scores of Menopause Rating Scale before and after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	288
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental perimenopausal women	Drug: an extract of Cimicifuga Foetida L. Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
A2: Placebo Comparator perimenopausal women	Drug: placebo Each patient will be given placebo of 2 tablets each day for 3 months.
B1: Experimental early staged postmenopausal women	Drug: an extract of Cimicifuga Foetida L. Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
B2: Placebo Comparator early staged postmenopausal women	Drug: placebo Each patient will be given placebo of 2 tablets each day for 3 months.

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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622986

Contacts

Contact: Shouqing Lin, MD

86-10-88068846

shouqing_lin2003@yahoo.com.cn

Locations

China
Bejing Union Hospital	Recruiting
Beijing, China, 100032
Contact: Shouqing Lin, MD 86-10-88068846 shouqing_lin2003@yahoo.com.cn
Contact: Aijun Sun, MD 86-10-88068848 sunaj25@sina.com
Principal Investigator: Shouqing Lin, MD
The Great Wall Hospital	Recruiting
Beijing, China, 100853
Contact: Lei Song, MD 86-10-66939351 songl301@hotmail.com
Contact: Wensheng Fan, MD 86-10-66937254
Principal Investigator: Lei Song, MD
International Peace Maternity & Child Health Hospital Of The China Welfare Institute	Recruiting
Shanghai, China, 200030
Contact: Kun Qi, MD 86-21-64070434 ext 25517 ipmch_kjk@yahoo.com.cn
Principal Investigator: Kun Qi, MD
Daping Hospital	Recruiting
Chongqing, China, 400042
Contact: Li Li, MD 86-23-68757310 xglili@mail.dph-fsi.com
Principal Investigator: Li Li, MD
Southwest Hospital	Recruiting
Chongqing, China, 400038
Contact: Zhiqing Liang, MD 86-23-68754409 ext 0 zhi.Lzliang@gmail.com
Contact: Cheng Chen, MD 86-23-68754409 ext 0 chencheng961@126.com
Principal Investigator: Zhiqing Liang, MD
Obstetrics & Gynecology Hospital Of Fudan University	Recruiting
Shanghai, China, 200011
Contact: Congjuan Cheng, MD +8613788965050 ext 6684 chengcongjuan@163.com
Principal Investigator: Congjuan Cheng, MD
Tianjin City Hospital for Gynaecology and Obsterics	Recruiting
Tianjin, China, 300025
Contact: Wanjun Lin, MD 86-22-23043612 linwanjun5835@hotmail.com
Principal Investigator: Wanjun Lin, MD
China, Fujian
Fujian Provincal Maternal and Children Health Hospital	Recruiting
Fuzhou, Fujian, China, 350001
Contact: Yuan Lin, MD 86-591-88892678 ext 0 Alice-96@163.com
Principal Investigator: Yuan Lin, MD
China, Guangdong
The First Affiliated Hospital，SUN YAT-SEN University	Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Shuzhong Yao, MD 86-20-87332200 ext 8342 yszlfy@163.com
Contact: Liping Feng, MD 86-20-87332200 ext 8342
Principal Investigator: Shuzhong Yao, MD
China, Hunan
Zhongnan University Xiangya No.3. Hospital	Recruiting
Changsha, Hunan, China, 410013
Contact: Xinliang Deng, MD 86-731-8618560 ext 0 lovezz_dxl@yeah.net
Contact: Min Xue, MD 86-731-8618040 ext 0
Principal Investigator: Min Xue, MD
China, Hunnan
Zhongnan University Xiangya No.2. Hospital	Recruiting
Changsha, Hunnan, China, 410011
Contact: Hongwen Zhang, MD 86-731-5295007 ext 0 zhw6216@yahoo.com
Contact: Fengzhi Liu, MD 86-731-5295219 ext 0
Principal Investigator: Fengzhi Liu, MD
China, Shandong
The Medical School Hospital Of Qingdao University	Recruiting
Qingdao, Shandong, China, 266003
Contact: Shuping Zhao, MD 86-532-82911314 zhaoshuping2006@163.com
Principal Investigator: Shuping Zhao, MD
Shandong Provincial Hospital	Recruiting
Jinan, Shandong, China, 250021
Contact: Zhongli Yang, MD 86-531-87938911 ext 6380 yangzhongli121@sina.com
Principal Investigator: Zhongli Yang, MD

Sponsors and Collaborators

Shandong Luye Pharmaceutical Co., Ltd.

Investigators

Study Chair:

Shouqing Lin, MD

Beijing Union Hospital

More Information

No publications provided

Responsible Party:	Beijing Union Hospital ( Prof. Lin Shouqing )
Study ID Numbers:	XMT-5Cs-002-2007
Study First Received:	February 14, 2008
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00622986 History of Changes
Health Authority:	China: Ministry of Health; China: State Food and Drug Administration

ClinicalTrials.gov processed this record on March 16, 2009