Menopausal WomenPhase 3NCT01264068
The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
A Phase 3 study testing Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San in people with Menopausal Women, run by Taipei City Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- What is being tested?
- Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Insomnia according to PSQI>6
- Informed consent
- Female
- Age 40-65 years
Who cannot join
- 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..
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital
Taipei, Taiwan, 111
Jung-Nien Lai, PHD, 02-28353456 ext. 6651, kareny@ms10.hinet.net
Chia-Hao Yeh, bachelor
About this study
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.
- Conditions
- Menopausal Women
- Being tested
- Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San
- Keywords
- Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau SanDrug
Take medicine every day 3 times, each time 4 grams.
| Study group | Role | What they receive |
|---|---|---|
| Insomnia control | No intervention | Not described |
| Suan Tsao Jen Tang | Experimental | Not described Receives: Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San |
| Jia-Wey Shiau-Yau San | Experimental | Not described Receives: Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total metabolites detection using LC/MS/MS
Measured: one month
Secondary outcomes (1)
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startAug 2008
- Primary completionApr 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital
- Investigators
- Yen-Hui Chen, PHD, Study chair, Associate Professor, School of Pharmacy,National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264068
- Sponsor's protocol ID
- TCHIRB-970208-E
- Status last verified
- Mar 2008
- First submitted
- 20 Dec 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
- ClinicalTrials.gov ID
- NCT01264068
- Acronym / sponsor ID
- TCHIRB-970208-E
- Conditions
- Menopausal Women
- Keywords
- Suan-Tsao-Jen-Tang ,Jia-Wey-Shiau-Yau-San,metabolomics,menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Taiwan University Hospital
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insomnia control | No intervention | – |
| Suan Tsao Jen Tang | Experimental | Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San |
| Jia-Wey Shiau-Yau San | Experimental | Drug: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Insomnia according to PSQI>6
- Informed consent
- Female
- Age 40-65 years
Key exclusion criteria (3 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau SanTake medicine every day 3 times, each time 4 grams. | Drug | Jia-Wey Shiau-Yau San, Suan Tsao Jen Tang |
Primary outcome
Total metabolites detection using LC/MS/MS
Time frame: one month
1 secondary outcome
1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Hui Chen, PHD study chair
Associate Professor, School of Pharmacy,National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San in people with Menopausal Women, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total metabolites detection using LC/MS/MS (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2010.