HealthyNCT01920997
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
An observational study of Healthy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Oct 2013
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women with normal menstrual cycles aged 40-50
Who may be able to join
- Healthy women with normal menstrual cycles aged 40-50.
- The score of Kupperman index is less than 15.
- Not alcoholics or smokers (past or smoking).
- Get subjects informed consent process should comply with GCP requirements.
Who cannot join
- Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
- Volunteers are participating in other clinical trials within 3 months.
- Volunteers who donated blood or loosed blood heavily within 3 months.
- Volunteers with previous history of mental illness, drug abuse or drug dependence.
- Volunteers who took drugs within 14 days before the trail.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 210038
Yang Jie, MD, +86-0510-85350351, yangjie@wuxiph.com
He Qing, MD
About this study
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.
- Conditions
- Healthy
- Keywords
- Healthy, normal menstrual cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No drug intervention | The objective of this study is to investigate the expression of NEI network and urine metabolomics of healthy women with normal menstrual cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of NEI network and Urine metabolomics
The indices of NEI network include:
- Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT
- Hypothalamic-pituitary-thyroid axis: TRH, T3, T4
- Renin - angiotensin - aldosterone system: PRA, Ang2, ALD
- Sex hormones: E2, FSH
- Immune factors: TNF-α、IL-6、IL-1
- Cardiovascular indicators: ET, NO, Hcy, Folic acid
Measured: 2-5 days after menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920997
- Sponsor's protocol ID
- QE-2458-3
- Status last verified
- Sep 2013
- First submitted
- 8 Aug 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
- ClinicalTrials.gov ID
- NCT01920997
- Acronym / sponsor ID
- QE-2458-3
- Conditions
- Healthy
- Keywords
- Healthy, normal menstrual cycles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Wuxi People's Hospital
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (estimated)
- First posted
- 13 Aug 2013 (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.
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No drug intervention | – | –The objective of this study is to investigate the expression of NEI network and urine metabolomics of healthy women with normal menstrual cycles. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women with normal menstrual cycles aged 40-50
Key inclusion criteria (4 listed)
- Healthy women with normal menstrual cycles aged 40-50.
- The score of Kupperman index is less than 15.
- Not alcoholics or smokers (past or smoking).
- Get subjects informed consent process should comply with GCP requirements.
Key exclusion criteria (5 listed)
- Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
- Volunteers are participating in other clinical trials within 3 months.
- Volunteers who donated blood or loosed blood heavily within 3 months.
- Volunteers with previous history of mental illness, drug abuse or drug dependence.
- Volunteers who took drugs within 14 days before the trail.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The expression of NEI network and Urine metabolomics
Time frame: 2-5 days after menstruation
The indices of NEI network include: 1. Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT 2. Hypothalamic-pituitary-thyroid axis: TRH, T3, T4 3. Renin - angiotensin - aldosterone system: PRA, Ang2, ALD 4. Sex hormones: E2, FSH 5. Immune factors: TNF-α、IL-6、IL-1 6. Cardiovascular indicators: ET, NO, Hcy, Folic acid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 5 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 4 Sep 2013. 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 China. 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.
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?
Contact Zheng Qingshan, PhD (+86-021-51322556, zheng.zqs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression of NEI network and Urine metabolomics (time frame: 2-5 days after menstruation). 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 4 Sep 2013.