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

December 20, 2010 updated by: Taipei City Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 111
        • Recruiting
        • Taipei City Hospital
        • Contact:
        • Sub-Investigator:
          • Chia-Hao Yeh, bachelor

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Insomnia control
Experimental: Suan Tsao Jen Tang
Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
Take medicine every day 3 times, each time 4 grams.
Experimental: Jia-Wey Shiau-Yau San
Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
Take medicine every day 3 times, each time 4 grams.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total metabolites detection using LC/MS/MS
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)
Time Frame: one month
one month

Collaborators and Investigators

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

Sponsor

Taipei City Hospital

Collaborators

National Taiwan University Hospital

Investigators

  • Study Chair: Yen-Hui Chen, PHD, Associate Professor, School of Pharmacy,National Taiwan University

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

August 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TCHIRB-970208-E

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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