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

Menopausal Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933725
• Other study ID #: 2007BAI20B014
• Secondary ID: 2007BAI20B014
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2009
• Last updated: June 15, 2012
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2010
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopausal Syndrome
• Syndrome

Intervention

Other:
• TCM intervention
Drug: Particle of compound Chinese herbs(produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. One tablet placebo of Tibolone (provided by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months. Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.
• Western intervention
Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.

Locations

Country	Name	City	State
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	Foshan Hospital of Traditional Chinese Medicine	Foshan	Guangdong
China	Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Liwan Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Longhua Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai
China	Baokang Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin
China	Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Affiliated Hospital of Hubei College of Traditional Chinese Medicine	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kupperman index		2 months	No
Secondary	blood serum estradiol		2 months	No