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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Taipei City Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264068
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
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.
Collaborator:
National Taiwan University Hospital
Information provided by:
Taipei City Hospital
  Purpose
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 Intervention Phase
Menopausal Women Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • Total metabolites detection using LC/MS/MS [ Time Frame: one month ]

Secondary Outcome Measures:
  • 1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI) [ Time Frame: one month ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01264068


Locations
Taiwan
Taipei City Hospital Recruiting
Taipei City, Taiwan, 111
Contact: Jung-Nien Lai, PHD    02-28353456 ext 6651    kareny@ms10.hinet.net   
Sub-Investigator: Chia-Hao Yeh, bachelor         
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
  More Information

Responsible Party: Jung-Lien Lai/Taipei City Hospital, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01264068     History of Changes
Other Study ID Numbers: TCHIRB-970208-E
First Submitted: December 20, 2010
First Posted: December 21, 2010
Last Update Posted: December 21, 2010
Last Verified: March 2008

Keywords provided by Taipei City Hospital:
Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause