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Development of Active Safety Surveillance System for Traditional Chinese Medicine

This study has been completed.
Department of Health
Information provided by:
National Taiwan University Hospital Identifier:
First received: January 11, 2006
Last updated: October 23, 2008
Last verified: June 2005

Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a paucity of data supporting their efficacy and safety.

Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.

Design and Setting:A multi-center, prospective, observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals.

Participants:In total, 136 eligible subjects entered this study. They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations.

Main Outcome Measures:During the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (AEs) occurring to them by using Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug. Every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of tolerability. During the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.

Condition Intervention Phase
Climacteric Symptoms Hot Flushes and/or Sweats Drug: TMN-1 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by National Taiwan University Hospital:

Study Start Date: February 2004
Estimated Study Completion Date: September 2004

Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  1. women between age of 45 and 55 and suffered from hot flushes and/or sweats
  2. had not participated in any trial within the previous 3 months before beginning this study
  3. were willing to participate in the trial and give written informed consent

Exclusion Criteria:

  1. had received any form of hormonal therapy within 3 months prior to the study
  2. had been diagnosed with any form of cancer and under treatment
  3. were afflicted with abnormal uterine bleeding and unknown etiology
  4. had hypertension or diabetes mellitus and were under treatment for these conditions
  5. had any abnormal finding for kidney, liver, or thyroid functions
  6. were currently taking antidepressants, alpha or beta-blocking agent, e.g., clomidine, ergot, ergot derivatives, or anti-estrogen medications such as tamoxifen and/or herbal hormones (isoflavon
  7. were suffering from arrhythmia or any other form of heart disease.
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Please refer to this study by its identifier: NCT00275964

Sponsors and Collaborators
National Taiwan University Hospital
Department of Health
Study Director: Jung Der Wang, M.D., Sc.D., Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health
  More Information Identifier: NCT00275964     History of Changes
Other Study ID Numbers: 920807
Study First Received: January 11, 2006
Last Updated: October 23, 2008 processed this record on September 19, 2017