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

Sponsor

Guangzhou University of Traditional Chinese Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00933725

Collaborator

(none)

194

Enrollment

Locations

Arms

Duration (Months)

24.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Syndrome	Other: TCM intervention Other: Western intervention	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Kupperman index [2 months]

Secondary Outcome Measures

blood serum estradiol [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

41 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan	China	610075
6	Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China	325000
7	Longhua Hospital of Shanghai University of Traditional Chinese Medicine	Shanghai		China	200032
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangzhou University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT00933725

Other Study ID Numbers:

2007BAI20B014
2007BAI20B014

First Posted:

Jul 7, 2009

Last Update Posted:

Jun 18, 2012

Last Verified:

May 1, 2010

Keywords provided by Guangzhou University of Traditional Chinese Medicine

menopausal syndrome

TCM intervention

Additional relevant MeSH terms:

Syndrome

Study Results

No Results Posted as of Jun 18, 2012