Development of Active Safety Surveillance System for Traditional Chinese Medicine

October 23, 2008 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jung Der Wang, M.D., Sc.D.,, Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2008

Last Update Submitted That Met QC Criteria

October 23, 2008

Last Verified

June 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • 920807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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