The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women

Phase 3

• Conditions: Menopausal Women
• Interventions: Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San

• Registration Number: NCT01264068
• Lead Sponsor: Taipei City Hospital

Brief Summary

Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. Many confounding factors influence activity of Chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. In this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive生化湯.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-03
• Study Start: 2008-08
• Primary Completion: 2009-04
• Study Completion: 2009-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Last Update Submitted: 2010-12-20
• Study First Posted: 2010-12-21
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Insomnia according to PSQI>6
• Informed consent
• Female
• Age 40-65 years

Exclusion Criteria

• In 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) .
• Spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer.
• Take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins,etc..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suan Tsao Jen Tang	Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San	-
Jia-Wey Shiau-Yau San	Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San	-

Primary Outcome Measures

Name	Time	Method
Total metabolites detection using LC/MS/MS	one month

Secondary Outcome Measures

Name	Time	Method
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)	one month

Trial Locations

Locations (1)

Taipei City Hospital; 🇨🇳 Taipei City, Taiwan