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

Sponsor
Taipei City Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01264068
Collaborator
National Taiwan University Hospital (Other)
60
Enrollment
1
Location
3
Arms
16
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2008
Anticipated Primary Completion Date :
Apr 1, 2009
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Total metabolites detection using LC/MS/MS [one month]

Secondary Outcome Measures

  1. 1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI) [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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..

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei City Hospital Taipei City Taiwan 111

Sponsors and Collaborators

  • Taipei City Hospital
  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01264068
Other Study ID Numbers:
  • TCHIRB-970208-E
First Posted:
Dec 21, 2010
Last Update Posted:
Dec 21, 2010
Last Verified:
Mar 1, 2008
Keywords provided by , ,
Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause

Study Results

No Results Posted as of Dec 21, 2010