OverweightXJXGNCT01142076
Xinju Xiaogao Prescription Study on Overweight
A study testing Xinju Xiaogao Prescription in people with Overweight, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight
- What is being tested?
- Xinju Xiaogao Prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Mar 2011
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years old
- BMI≥28kg/m2，but<40kg/m2
- Waistline≥85cm（male）,≥80cm（female）
- Pathoglycemia must fulfill one of those four condition:
- IGT,7.8≤2hPG≤11.0mmol/,
- diabetics take medicine used to treat type 2 diabetes more than 3 month,and 5.6≤FBG≤12.2,and weight change under 4kg.
- stagnation of QI causing phlegm retention
- To sign informed consent.
Who cannot join
- After 3-6 months simply controlling their diet and more exercise treatment, body weight weight loss ≥ 5%.
- TG>4.5mmol/L.
- Suffering from congenital heart disease, rheumatic heart disease, kidney disease, serious active liver disease, peptic ulcer disease or malabsorption syndrome.
- There is a history of pancreatitis or endocrine diseases other than diabetes, diabetes treated with insulin.
- Not suffered myocardial infarction in Past 3 months or unstable angina were confirmed.
- Had been diagnosed as "post-surgical adhesions" .
Show all 17Show fewer
- There is a history of appetite or abuse of laxatives
- Diastolic blood pressure,uncontrolled or controlled, three times greater than 105mmHg .
- Pregnancy, prepare to pregnant or lactating women prepare.
- Allergies to Chinese medicine , allergic.
- Recurrent gallstone or a history of kidney stones.
- Mentally ill.
- Cancer patients.
- A history of gastrointestinal surgery to lose weight.
- Receiving other clinical studies nearly 3 months.
- Alcohol and / or psychoactive substances, drug abusers and addicts.
- Taking other weight-reducing aid Close within one month
About this study
Official title: Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study
Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study
Read the detailed description
Charged by the three research centers in line with traditional Chinese medicine stagnation of QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids, blood sugar effect.
- Conditions
- Overweight
- Being tested
- Xinju Xiaogao Prescription, placebo
- Keywords
- adiposity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xinju Xiaogao PrescriptionDrug
Also called Xinju Xiaogao decoction
treatment group
placeboDrug
Therapeutic dose of 10%
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Dose treatment group, 10% Receives: Drug: placebo |
| Xinju Xiaogao Prescription | Active comparator | treatment group Receives: Drug: Xinju Xiaogao Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
waistline
Measured: up to 24 weeks
Secondary outcomes (1)
Body Mass Index (BMI)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Responsible party
- Principal investigator, Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Fenglian Li, PHD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142076
- Sponsor's protocol ID
- 19850701
- Acronym
- XJXG
- Status last verified
- Dec 2013
- First submitted
- 24 May 2010
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study
- ClinicalTrials.gov ID
- NCT01142076
- Acronym / sponsor ID
- XJXG / 19850701
- Conditions
- Overweight
- Keywords
- adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jun 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.
Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study
Detailed description
Charged by the three research centers in line with traditional Chinese medicine stagnation of QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids, blood sugar effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboDose treatment group, 10% |
| Xinju Xiaogao Prescription | Active comparator | Drug: Xinju Xiaogao Prescriptiontreatment group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18-60 years old
- BMI≥28kg/m2，but<40kg/m2
- Waistline≥85cm（male）,≥80cm（female）
- Pathoglycemia must fulfill one of those four condition:
- IGT,7.8≤2hPG≤11.0mmol/,
Key exclusion criteria (17 listed)
- After 3-6 months simply controlling their diet and more exercise treatment, body weight weight loss ≥ 5%.
- TG>4.5mmol/L.
- Suffering from congenital heart disease, rheumatic heart disease, kidney disease, serious active liver disease, peptic ulcer disease or malabsorption syndrome.
- There is a history of pancreatitis or endocrine diseases other than diabetes, diabetes treated with insulin.
- Not suffered myocardial infarction in Past 3 months or unstable angina were confirmed.
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 |
|---|---|---|
| Xinju Xiaogao PrescriptionAlso: Xinju Xiaogao decoctiontreatment group | Drug | Xinju Xiaogao Prescription |
| placeboTherapeutic dose of 10% | Drug | placebo |
Primary outcome
waistline
Time frame: up to 24 weeks
1 secondary outcome
Body Mass Index (BMI)
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
Fenglian Li, PHD study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Xinju Xiaogao Prescription in people with Overweight, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waistline (time frame: up to 24 weeks). 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 11 Dec 2013.