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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Menopausal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TCM intervention

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

Group Type EXPERIMENTAL

TCM intervention

Intervention Type OTHER

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

Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs

Group Type ACTIVE_COMPARATOR

Western intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

41 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No