Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Taipei City Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01264068
First received: December 20, 2010
Last updated: NA
Last verified: March 2008
History: No changes posted

December 20, 2010
December 20, 2010
August 2008
April 2009   (final data collection date for primary outcome measure)
Total metabolites detection using LC/MS/MS [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Menopausal Women
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.
  • No Intervention: Insomnia control
  • Experimental: Suan Tsao Jen Tang
    Intervention: Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
  • Experimental: Jia-Wey Shiau-Yau San
    Intervention: Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2009
April 2009   (final data collection date for primary outcome measure)

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..
Both
40 Years to 60 Years
Yes
Taiwan
 
NCT01264068
TCHIRB-970208-E
Not Provided
Jung-Lien Lai/Taipei City Hospital, Taipei City Hospital
Taipei City Hospital
National Taiwan University Hospital
Study Chair: Yen-Hui Chen, PHD Associate Professor, School of Pharmacy,National Taiwan University
Taipei City Hospital
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP