NCT00933725

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

Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: Female
• Age: 41 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Menopausal Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2009-07-07
• Last updated: 2012-06-18

Locations

8 sites across 1 country: China