CClinicalTrials.gg
Sign In
Status unknownNCT01264068Updated Dec 21, 2010

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

A Phase 3 interventional study of Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San in Menopausal Women, sponsored by Taipei City Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-21.

Sponsored by Taipei City Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Menopausal Women

Keywords

  • Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause
03

In context

Lead sponsor

Taipei City Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Insomnia according to PSQI>6
  • Informed consent
  • Female
  • Age 40-65 years

Exclusion criteria

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..
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Insomnia control
  • Experimental
    Suan Tsao Jen Tang

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

  • Experimental
    Jia-Wey Shiau-Yau San

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

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.

06

What researchers measure

Primary outcomes

  1. Total metabolites detection using LC/MS/MS

    Time frame: one month

Secondary outcomes

  1. 1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Taipei City Hospital
    Taipei City, 111, Taiwan
    • Jung-Nien Lai, PHD · Contact · kareny@ms10.hinet.net · 02-28353456
    • Chia-Hao Yeh, bachelor · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01264068
Lead sponsor
Taipei City Hospital
Collaborators
National Taiwan University Hospital
First posted
Dec 21, 2010
Start date
Aug 2008
Primary completion
Apr 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Dec 21, 2010

Study contacts

Yen-Hui Chen, PHD
study chair · Associate Professor, School of Pharmacy,National Taiwan University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Taipei City Hospital

Start the discussion