China Cimicifuga Trial of Climacteric Complaint Control (CCCCC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Shandong Luye Pharmaceutical Co., Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shandong Luye Pharmaceutical Co., Ltd.
Information provided by:
Shandong Luye Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00622986
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: February 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: 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 |
Resource links provided by NLM:
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 |
|---|---|
|
Experimental: A1
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.
Other Name: Ximingting
|
|
Placebo Comparator: A2
perimenopausal women
|
Drug: placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
Other Name: placebo
|
|
Experimental: B1
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.
Other Name: Ximingting
|
|
Placebo Comparator: B2
early staged postmenopausal women
|
Drug: placebo
Each patient will be given placebo of 2 tablets each day for 3 months.
Other Name: placebo
|
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, 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: Min Xue, MD 86-731-8618040 ext 0 | |
| Contact: Xinliang Deng, MD 86-731-8618560 ext 0 lovezz_dxl@yeah.net | |
| Principal Investigator: Min Xue, MD | |
| China, Hunnan | |
| Zhongnan University Xiangya No.2. Hospital | Recruiting |
| Changsha, Hunnan, China, 410011 | |
| Contact: Fengzhi Liu, MD 86-731-5295219 ext 0 | |
| Contact: Hongwen Zhang, MD 86-731-5295007 ext 0 zhw6216@yahoo.com | |
| Principal Investigator: Fengzhi Liu, MD | |
| China, Shandong | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
Sponsors and Collaborators
Shandong Luye Pharmaceutical Co., Ltd.
Investigators
| Study Chair: | Shouqing Lin, MD | Beijing Union Hospital |
More Information
No publications provided
| Responsible Party: | Prof. Lin Shouqing, Beijing Union Hospital |
| ClinicalTrials.gov Identifier: | NCT00622986 History of Changes |
| Other Study ID Numbers: | XMT-5Cs-002-2007 |
| Study First Received: | February 14, 2008 |
| Last Updated: | February 22, 2008 |
| Health Authority: | China: Ministry of Health China: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 22, 2013