Status:
COMPLETED
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Conditions:
Menopausal Syndrome
Eligibility:
FEMALE
41-60 years
Phase:
PHASE3
Brief Summary
The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion t...
Detailed Description
Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chin...
Eligibility Criteria
Inclusion
- Aged 41-60;
- Amenorrhea for at least 6 months;
- Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
- Hot flushes and night sweats symptoms;
- Vaginal secretion decreased with or without dyspareunia;
- Kupperman Index (KI) score ≥ 15;
- Self-rating Anxiety Scale or Self-rating Depression Scale standard score \>50,but \<72(standard score= scale score ×1.25);
- FSH ≥ 20 IU/L;
- Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
- Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.
Exclusion
- With malignant tumor in reproductive system;
- With benign tumor in reproductive system and need surgery;
- Malignant tumor in mammary gland;
- Irregular vaginal bleeding for unknown reasons;
- Thickness of endometrium ≥1.5cm by ultrasound examination;
- Have used Sex hormone medicine or joined other clinical trials 3 months before;
- Allergy;
- Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
- Severe psychiatric disease diagnosed by psychiatric physician;
- Refuse informed consent.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00933725
Start Date
August 1 2009
End Date
June 1 2011
Last Update
June 18 2012
Active Locations (8)
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1
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, China, 528000
2
Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120
3
Liwan Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510360
4
Affiliated Hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, China, 430061