Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome - Full Text View

Purpose

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.

Condition	Intervention	Phase
Menopausal Syndrome	Other: TCM intervention Other: Western intervention	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:

Kupperman index [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood serum estradiol [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	194
Study Start Date:	August 2009
Study Completion Date:	June 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TCM intervention Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone	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.
Active Comparator: Western intervention Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs	Other: 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.

Arms

Assigned Interventions

Experimental: TCM intervention

Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone

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.

Active Comparator: Western intervention

Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Other: 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.

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

Ages Eligible for Study:	41 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933725

Locations

China, Guangdong
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, China, 528000
Liwan Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510360
Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120
China, Hubei
Affiliated Hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, China, 430061
China, Sichuan
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610075
China, Zhejiang
Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
China
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, China, 200032
Baokang Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China, 300170

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine

Investigators

Principal Investigator:

Xiaoyun Wang, Bachelor

Guangzhou University of Traditional Chinese Medicine

More Information

No publications provided

Responsible Party:	Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00933725 History of Changes
Other Study ID Numbers:	2007BAI20B014, 2007BAI20B014
Study First Received:	July 2, 2009
Last Updated:	June 15, 2012
Health Authority:	China: Ethics Committee China: Ministry of Health China: Food and Drug Administration

Keywords provided by Guangzhou University of Traditional Chinese Medicine:

menopausal syndrome
TCM intervention

ClinicalTrials.gov processed this record on May 23, 2013