Trial record 10 of 78 for:    (complementary OR alternative) medicine AND menopause

Development of Active Safety Surveillance System for Traditional Chinese Medicine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275964
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : October 24, 2008
Department of Health
Information provided by:
National Taiwan University Hospital

Brief Summary:

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 or disease Intervention/treatment
Climacteric Symptoms Hot Flushes and/or Sweats Drug: TMN-1

Study Type : Observational
Time Perspective: Prospective
Study Start Date : February 2004
Study Completion Date : September 2004

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00275964     History of Changes
Other Study ID Numbers: 920807
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: June 2005