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Completed

NCT Number: NCT00421564

Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

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.

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Key information

Conditions

Menopause

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Obstetrics & Gynaecology, CUHK, Prince of Wales Hospital

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT-Danggui Buxue Tang

Drug

Primary outcomes

  1. The Changes in severity and frequency of hot flushes and sweats.

Secondary outcomes

  1. The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Study of the Effect of Danggui Buxue Tang on Menopausal Symptoms and Quality of Life in Hong Kong Chinese Women

Important dates

Study start
2003
Study completion
2004
First posted
Jan 12, 2007
Registry last updated
Jan 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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