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

Menopausal Women Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01264068
• Other study ID #: TCHIRB-970208-E
• Status: Recruiting
• Phase: Phase 3
• First received: December 20, 2010
• Last updated: December 20, 2010
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2008
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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..

Study Design

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

Related Conditions & MeSH terms

• Menopausal Women

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total metabolites detection using LC/MS/MS		one month	Yes
Secondary	1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)		one month	Yes