Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome

Phase 3

Completed

• Conditions: Menopausal Syndrome
• Interventions: Other: TCM intervention; Other: Western intervention

• Registration Number: NCT00933725
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2009-08
• Status Verified: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Last Update Submitted: 2012-06-15
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM intervention	TCM intervention	Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone
Western intervention	Western intervention	Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Primary Outcome Measures

Name	Time	Method
Kupperman index	2 months

Secondary Outcome Measures

Name	Time	Method
blood serum estradiol	2 months

Trial Locations

Locations (8)

Baokang Hospital of Tianjin University of Traditional Chinese Medicine; 🇨🇳 Tianjin, China

Foshan Hospital of Traditional Chinese Medicine; 🇨🇳 Foshan, Guangdong, China

Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China

Guangzhou University of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Liwan Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Hubei College of Traditional Chinese Medicine; 🇨🇳 Wuhan, Hubei, China

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China

Longhua Hospital of Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China