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

NCT00933725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2012-06-18

No results posted yet for this study

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.

Conditions

  • Menopausal Syndrome

Interventions

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.

Sponsors & Collaborators

  • Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Xiaoyun Wang, Bachelor · Guangzhou University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933725 on ClinicalTrials.gov