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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01264068

Enrollment

Registered

2010-12-21

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2010-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Women

Keywords

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

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.

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

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..

Design outcomes

Primary

Measure	Time frame
Total metabolites detection using LC/MS/MS	one month

Secondary

Measure	Time frame
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)	one month

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026