The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Total metabolites detection using LC/MS/MS [ Time Frame: one month ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
| 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 May 23, 2013