Weight LossNCT03325179
A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity
A study testing Thread-embedding Therapy in people with Weight Loss and Simple Obesity, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Thread-embedding Therapy has been used for treating Obesity in recent years. This research is aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity. One hundred patients is planned to be enrolled in the research and receive a thread-embedding therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Simple Obesity
- What is being tested?
- Thread-embedding Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2017to 31 Mar 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with age from 18 to 60 years old;
- patients with BMI≥ 24, meanwhile waist more than 85 cm (for male) or 80 cm (for female);
- patients with diagnosed as central adiposity and/or Simple obesity according to the diagnosis criteria；
- patients who is willing to cooperate with the test treatment and signed informed consent.
Who cannot join
- Pregnant or lactating women;
- patients who Syncope after acupuncture；
- patients who present hypersensitivity reactions after acupoint-embedding therapy;
- patients with serious heart, liver, kidney, brain and other diseases;
- patients with severe primary diseases;
- patients with psychiatric diseases；
- patients who did not meet the criteria for the inclusion criteria while investigators find out during the trial;
- participants who did not complete dietary control and physical exercise as the protocol described.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Digestive Diseases of Longhua Hospital affiliate to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Guang Ji, +86-64385700 ext. 9503, jiliver@vip.sina.com
About this study
Official title: A Clinical Trial of Acupoint Thread-embedding Therapy for Simple Obesity
Thread-embedding Therapy has been used for treating Obesity in recent years. This research is aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity. One hundred patients is planned to be enrolled in the research and receive a thread-embedding therapy. The level of BMI, serum triglyceride, cholesterol and fasting blood glucose will be adopted for evaluation before and after therapy.
Read the detailed description
Each participant will receive thread-embedding therapy every two weeks, and eight times in all.Blood test will be taken at the beginning of the first week of the whole therapy, and at the end of the 8th therapy. During the periods of whole therapy, the participants shall follow diets control and physical exercise as the protocol described.
- Conditions
- Weight Loss, Simple Obesity
- Being tested
- Thread-embedding Therapy
- Keywords
- Simple Obesity, Thread-embedding Therapy, Acupuncture
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-embedding TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| participants received treatment | Experimental | 100 participants who are diagnosed as simple obesity under the standards of... are planned to enrolled in the trial. Each will receive Thread-embedding therapy. Receives: Other: Thread-embedding Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change Body Weight
a 5 percent of loss of body weight will be judged as effective
Measured: participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all.
Secondary outcomes (3)
The effection on cholesterol
a target examined by blood test, in order to compare the Lipid metabolism
Measured: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
The effection on triglyceride
a target examined by blood test, in order to compare the Lipid metabolism
Measured: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
The effection on fasting blood glucose
to compare the level of glucose in order to get the message of improvement of blood glucose disorder by our therapy.
Measured: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start3 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325179
- Sponsor's protocol ID
- shutcmidd
- Status last verified
- Jun 2017
- First submitted
- 3 Sep 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Acupoint Thread-embedding Therapy for Simple Obesity
- ClinicalTrials.gov ID
- NCT03325179
- Acronym / sponsor ID
- shutcmidd
- Conditions
- Weight Loss, Simple Obesity
- Keywords
- Simple Obesity, Thread-embedding Therapy, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 30 Oct 2017 (actual)
- 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.
Thread-embedding Therapy has been used for treating Obesity in recent years. This research is aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity. One hundred patients is planned to be enrolled in the research and receive a thread-embedding therapy. The level of BMI, serum triglyceride, cholesterol and fasting blood glucose will be adopted for evaluation before and after therapy.
Detailed description
Each participant will receive thread-embedding therapy every two weeks, and eight times in all.Blood test will be taken at the beginning of the first week of the whole therapy, and at the end of the 8th therapy. During the periods of whole therapy, the participants shall follow diets control and physical exercise as the protocol described.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants received treatment | Experimental | Other: Thread-embedding Therapy100 participants who are diagnosed as simple obesity under the standards of... are planned to enrolled in the trial. Each will receive Thread-embedding therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with age from 18 to 60 years old;
- patients with BMI≥ 24, meanwhile waist more than 85 cm (for male) or 80 cm (for female);
- patients with diagnosed as central adiposity and/or Simple obesity according to the diagnosis criteria；
- patients who is willing to cooperate with the test treatment and signed informed consent.
Key exclusion criteria (8 listed)
- Pregnant or lactating women;
- patients who Syncope after acupuncture；
- patients who present hypersensitivity reactions after acupoint-embedding therapy;
- patients with serious heart, liver, kidney, brain and other diseases;
- patients with severe primary diseases;
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 |
|---|---|---|
| Thread-embedding Therapy | Other | participants received treatment |
Primary outcome
The change Body Weight
Time frame: participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all.
a 5 percent of loss of body weight will be judged as effective
3 secondary outcomes
The effection on cholesterol
Time frame: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
The effection on triglyceride
Time frame: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
The effection on fasting blood glucose
Time frame: Therapy is the same as mentioned above. Participants will take blood test at the beginning of the first week of the therapy, and at the end of the 16th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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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?
A study testing Thread-embedding Therapy in people with Weight Loss and Simple Obesity, 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 8 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 30 Oct 2017. 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 Miao Wang (+86-64385700 ext. 9507, wangmiao_126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change Body Weight (time frame: participants will receive Thread-embedding Therapy twice a week lasting for 16 weeks subsequently.8 times in all.). 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 30 Oct 2017.