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

Guangzhou University of Traditional Chinese Medicine194 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

194

Conditions

Menopausal Syndrome

Interventions

TCM interventionOTHER

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 interventionOTHER

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.

Eligibility

Sex: FEMALEMin age: 41 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (8)

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

Outcomes

Primary Outcomes

Kupperman index

Time frame: 2 months

Secondary Outcomes

blood serum estradiol

Time frame: 2 months

Data from ClinicalTrials.gov

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