Development of Active Safety Surveillance System for Traditional Chinese Medicine

Climacteric Symptoms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275964
• Other study ID #: 920807
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2006
• Last updated: October 23, 2008
• Start date: February 2004
• Est. completion date: September 2004

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2004
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Climacteric Symptoms
• Hot Flushes and/or Sweats

Intervention

Drug:
• TMN-1

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Department of Health