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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • Total metabolites detection using LC/MS/MS [ Time Frame: one month ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 20, 2010
Last Updated: December 20, 2010
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014