Status:
COMPLETED
Chinese Medicine Therapy on Menopausal Symptoms
Lead Sponsor:
The University of Hong Kong
Conditions:
Menopause
Eligibility:
FEMALE
45-55 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.
Detailed Description
This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms. This study will b...
Eligibility Criteria
Inclusion
- Chinese women aged 45 to 55 years old
- having irregular menstrual cycles (≥3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months
- Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe
- Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study
- Willing to give informed ,written consent to participate in the clinical study
Exclusion
- Taking hormones or medications, which could affect the vasomotoric symptoms
- Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
- Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis
- Consuming alcohol, or taking psychiatric or psychotherapeutic drugs
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00799734
Start Date
April 1 2009
End Date
June 1 2011
Last Update
July 26 2011
Active Locations (2)
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1
Department of Obstetrics and Gynecology, the University of Hong Kong
Hong Kong, Hksar, China
2
Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong
Hong Kong, Hong Kong, China