Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Conditions

Menopause

Treatments

Drug: DBT-Danggui Buxue Tang

Study type

Interventional

Funder types

Other

Identifiers

NCT00421564

ICM/CTS/004

Details and patient eligibility

About

This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

Patients with a history of using any form of hormonal replacement therapy within 8 weeks
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
Patients with a history of significant drug hypersensitivity