Clinical trial NCT00933725: Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome
Official title: Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopausal Syndrome
Keywords: menopausal syndrome
TCM intervention
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 194
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment in women with menopausal syndrome.

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 Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Kupperman index
timeFrame: 2 months
Secondary outcomes:
measure: blood serum estradiol
timeFrame: 2 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: Foshan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou University of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Liwan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Wuhan
country: China
facility: Affiliated Hospital of Hubei College of Traditional Chinese Medicine
state: Hubei
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Wenzhou
country: China
facility: Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Shanghai
country: China
facility: Longhua Hospital of Shanghai University of Traditional Chinese Medicine
city: Tianjin
country: China
facility: Baokang Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
affiliation: Guangzhou University of Traditional Chinese Medicine
name: Xiaoyun Wang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: