Climacteric SymptomsPhase 4CCCCCNCT00622986
China Cimicifuga Trial of Climacteric Complaint Control
A Phase 4 study testing an extract of Cimicifuga Foetida L. in people with Climacteric Symptoms, run by Shandong Luye Pharmaceutical Co., Ltd. at 13 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Climacteric Symptoms
- What is being tested?
- an extract of Cimicifuga Foetida L.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 13 sitesChina
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Bejing Union Hospital
Beijing, 100032
Shouqing Lin, MD, 86-10-88068846, shouqing_lin2003@yahoo.com.cn
Aijun Sun, MD, 86-10-88068848, sunaj25@sina.com
- Recruiting
The Great Wall Hospital
Beijing, 100853
Lei Song, MD, 86-10-66939351, songl301@hotmail.com
Wensheng Fan, MD, 86-10-66937254
- Recruiting
Zhongnan University Xiangya No.3. Hospital
Changsha, Hunan, 410013
Min Xue, MD, 86-731-8618040 ext. 0
Xinliang Deng, MD, 86-731-8618560 ext. 0, lovezz_dxl@yeah.net
- Recruiting
Zhongnan University Xiangya No.2. Hospital
Changsha, Hunnan, 410011
Fengzhi Liu, MD, 86-731-5295219 ext. 0
Hongwen Zhang, MD, 86-731-5295007 ext. 0, zhw6216@yahoo.com
- Recruiting
Southwest Hospital
Chongqing, 400038
Zhiqing Liang, MD, 86-23-68754409 ext. 0, zhi.Lzliang@gmail.com
Cheng Chen, MD, 86-23-68754409 ext. 0, chencheng961@126.com
- Recruiting
Daping Hospital
Chongqing, 400042
Li Li, MD, 86-23-68757310, xglili@mail.dph-fsi.com
Li Li, MD
- Recruiting
Fujian Provincal Maternal and Children Health Hospital
Fuzhou, Fujian, 350001
Yuan Lin, MD, 86-591-88892678 ext. 0, Alice-96@163.com
Yuan Lin, MD
- Not yet recruiting
The First Affiliated Hospital，SUN YAT-SEN University
Guangzhou, Guangdong, 510080
Shuzhong Yao, MD, 86-20-87332200 ext. 8342, yszlfy@163.com
Liping Feng, MD, 86-20-87332200 ext. 8342
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Zhongli Yang, MD, 86-531-87938911 ext. 6380, yangzhongli121@sina.com
Zhongli Yang, MD
- Recruiting
The Medical School Hospital Of Qingdao University
Qingdao, Shandong, 266003
Shuping Zhao, MD, 86-532-82911314, zhaoshuping2006@163.com
Shuping Zhao, MD
- Recruiting
Obstetrics & Gynecology Hospital Of Fudan University
Shanghai, 200011
Congjuan Cheng, MD, +8613788965050 ext. 6684, chengcongjuan@163.com
Congjuan Cheng, MD
- Recruiting
International Peace Maternity & Child Health Hospital Of The China Welfare Institute
Shanghai, 200030
Kun Qi, MD, 86-21-64070434 ext. 25517, ipmch_kjk@yahoo.com.cn
Kun Qi, MD
- Recruiting
Tianjin City Hospital for Gynaecology and Obsterics
Tianjin, 300025
Wanjun Lin, MD, 86-22-23043612, linwanjun5835@hotmail.com
Wanjun Lin, MD
About this study
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
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
Read the 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.
- Conditions
- Climacteric Symptoms
- Being tested
- an extract of Cimicifuga Foetida L., placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an extract of Cimicifuga Foetida L.Drug
Also called Ximingting
Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
an extract of Cimicifuga Foetida L.Drug
Also called Ximingting
Each patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months.
placeboDrug
Each patient will be given placebo of 2 tablets each day for 3 months.
placeboDrug
Each patient will be given placebo of 2 tablets each day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | perimenopausal women Receives: Drug: an extract of Cimicifuga Foetida L. |
| A2 | Placebo comparator | perimenopausal women Receives: Drug: placebo |
| B1 | Experimental | early staged postmenopausal women Receives: Drug: an extract of Cimicifuga Foetida L. |
| B2 | Placebo comparator | early staged postmenopausal women Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of scores of Kupperman Index before and after the treatment
Measured: 3 months
Secondary outcomes (1)
Change of scores of Menopause Rating Scale before and after the treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shouqing Lin, MD, Study chair, Beijing Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622986
- Sponsor's protocol ID
- XMT-5Cs-002-2007
- Acronym
- CCCCC
- Status last verified
- Feb 2008
- First submitted
- 14 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00622986
- Acronym / sponsor ID
- CCCCC / XMT-5Cs-002-2007
- Conditions
- Climacteric Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: an extract of Cimicifuga Foetida L.perimenopausal women |
| A2 | Placebo comparator | Drug: placeboperimenopausal women |
| B1 | Experimental | Drug: an extract of Cimicifuga Foetida L.early staged postmenopausal women |
| B2 | Placebo comparator | Drug: placeboearly staged postmenopausal women |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an extract of Cimicifuga Foetida L.Also: XimingtingEach patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months. | Drug | B1 |
| an extract of Cimicifuga Foetida L.Also: XimingtingEach patient will be given the medication of extract of Cimicifuga Foetida L. 2 tablets each day for 3 months. | Drug | A1 |
| placeboEach patient will be given placebo of 2 tablets each day for 3 months. | Drug | A2 |
| placeboEach patient will be given placebo of 2 tablets each day for 3 months. | Drug | B2 |
Primary outcome
Change of scores of Kupperman Index before and after the treatment
Time frame: 3 months
1 secondary outcome
Change of scores of Menopause Rating Scale before and after the treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shouqing Lin, MD study chair
Beijing Union Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing an extract of Cimicifuga Foetida L. in people with Climacteric Symptoms, run by Shandong Luye Pharmaceutical Co., Ltd. at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shouqing Lin, MD (86-10-88068846, shouqing_lin2003@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of scores of Kupperman Index before and after the treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.