China Cimicifuga Trial of Climacteric Complaint Control (NCT00622986) | Clinical Trial Compass
UnknownPhase 4
China Cimicifuga Trial of Climacteric Complaint Control
China288 participantsStarted 2008-02
Plain-language 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
Who can participate
Age range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of scores of Kupperman Index before and after the treatment