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

NCT ID: NCT01264068

Last Updated: 2010-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menopausal Women

Keywords

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Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Insomnia control

Group Type NO_INTERVENTION

No interventions assigned to this group

Suan Tsao Jen Tang

Group Type EXPERIMENTAL

Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San

Intervention Type DRUG

Take medicine every day 3 times, each time 4 grams.

Jia-Wey Shiau-Yau San

Group Type EXPERIMENTAL

Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San

Intervention Type DRUG

Take medicine every day 3 times, each time 4 grams.

Interventions

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Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San

Take medicine every day 3 times, each time 4 grams.

Intervention Type DRUG

Eligibility Criteria

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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..
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Taipei City Hospital

Principal Investigators

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Yen-Hui Chen, PHD

Role: STUDY_CHAIR

Associate Professor, School of Pharmacy,National Taiwan University

Locations

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Taipei City Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Jung-Nien Lai, PHD

Role: primary

Other Identifiers

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TCHIRB-970208-E

Identifier Type: -

Identifier Source: org_study_id