The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 21, 2010
CompletedDecember 21, 2010
March 1, 2008
8 months
December 20, 2010
December 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total metabolites detection using LC/MS/MS
one month
Secondary Outcomes (1)
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)
one month
Study Arms (3)
Insomnia control
NO INTERVENTIONSuan Tsao Jen Tang
EXPERIMENTALJia-Wey Shiau-Yau San
EXPERIMENTALInterventions
Take medicine every day 3 times, each time 4 grams.
Eligibility Criteria
You may qualify if:
- Insomnia according to PSQI\>6
- Informed consent
- Female
- Age 40-65 years
You may not qualify if:
- 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..
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei City Hospitallead
- National Taiwan University Hospitalcollaborator
Study Sites (1)
Taipei City Hospital
Taipei, Taiwan, 111, Taiwan
Study Officials
- STUDY CHAIR
Yen-Hui Chen, PHD
Associate Professor, School of Pharmacy,National Taiwan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 21, 2010
Study Start
August 1, 2008
Primary Completion
April 1, 2009
Study Completion
December 1, 2009
Last Updated
December 21, 2010
Record last verified: 2008-03