Dose Finding Study of Danggui Buxue Tang (Herbal Formula)on the Treatment of Menopausal Symptoms

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Main purpose of the study is to look for an optimal dose for the treatment of menopausal symptoms with the Chinese Herbal Medicines containing Dang Gui and Huang Qi.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l)

• Patients with amenorrhoea for more than 12 months

• Never received treatment for menopausal symptoms

• Never received menopausal hormone therapy

• Reporting a minimum of 21 hot flushes per week at the time of entry into the study

Exclusion Criteria:

• Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks

• Patients who in the judgment of the investigator will be unable to comply with protocol requirements.

• Patients with significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases;

• Patients with uncontrolled hypertension,

• Patients with undiagnosed vaginal bleeding