ObesityNCT02108236
Effectiveness and Safety of Acupuncture for Obesity and Over-weight People
A study testing acupuncture in people with Obesity and Overweight, run by Heilongjiang University of Chinese Medicine at 1 site in China.
Trial summary
To determine the efficacy and safety of acupuncture for obesity and overweight people in China. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The individuals is phlegm-dampness constitution and female.
- Age is between 18 and 45 years.
- BMI is between 24 and 50.
- The individuals voluntarily sign the informed consent form.
- The individuals live in Harbin City of China.
Who cannot join
- Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
- The individuals with server cardiovascular and cerebrovascular diseases and cancer.
- Having therapy for obesity in the last three months.
- The individuals do not adhere to the treatment or are with other treatments.
- Female individuals with pregnancy, lactation and planning a pregnancy in the two months.
- Critical patients or patients combined with liver and kidney damage.
- Individuals with visual and auditory memory disorders or psychosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
About this study
To determine the efficacy and safety of acupuncture for obesity and overweight people in China.
- Conditions
- Obesity, Overweight
- Being tested
- acupuncture
- Keywords
- acupuncture, chinese traditional medicine
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Zhong-wan (RN12), Liang-men (ST21), Shui-fen (RN9) and Qi-hai (RN6) and bilateral acupuncture points Dai-mai (GB26), Tian-shu (ST25), Zu-sanli (ST36), Feng-long(ST40) and Liang-qiu(ST34) will be applied through the skin by acupuncture for 30 minutes every time. Electro-acupuncture apparatus will be connected to both Dai-mai, Zu-sanli and Feng-long, Zhong-wan and Qi-hai for 30 minutes with interrupted waves (2/100HZ).
| Study group | Role | What they receive |
|---|---|---|
| Blank control group | No intervention | A control group of patients is put on a waiting list for no intervention and remaining unchanged lifestyle. |
| intervention group | Active comparator | An intervention group of patients is put on a waiting list for acupuncture treatment. Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index(BMI)
Measured: 2 month after treatment
Secondary outcomes (6)
waist-to-hip ratio (WHR)
Measured: 2 month after treatment
Blood sugar
Measured: 2 month after treatment
Total cholesterol
Measured: 2 month after treatment
Triglycerides
Measured: 2 month after treatment
High-density lipoprotein cholesterol
Measured: 2 month after treatment
Low-density lipoprotein cholesterol
Measured: 2 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Ling Shu, Heilongjiang University of Chinese Medicine
- Investigators
- Sun Zhongren, Principal investigator, First Affiliated Hospital of Heilongjiang Chinese Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108236
- Sponsor's protocol ID
- Acupuncture-Obesity-2014-3
- Status last verified
- Mar 2015
- First submitted
- 30 Mar 2014
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Acupuncture for Obesity and Over-weight People
- ClinicalTrials.gov ID
- NCT02108236
- Acronym / sponsor ID
- Acupuncture-Obesity-2014-3
- Conditions
- Obesity, Overweight
- Keywords
- acupuncture, chinese traditional medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (estimated)
- First posted
- 9 Apr 2014 (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.
To determine the efficacy and safety of acupuncture for obesity and overweight people in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blank control group | No intervention | –A control group of patients is put on a waiting list for no intervention and remaining unchanged lifestyle. |
| intervention group | Active comparator | Device: acupunctureAn intervention group of patients is put on a waiting list for acupuncture treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The individuals is phlegm-dampness constitution and female.
- Age is between 18 and 45 years.
- BMI is between 24 and 50.
- The individuals voluntarily sign the informed consent form.
- The individuals live in Harbin City of China.
Key exclusion criteria (7 listed)
- Secondary obesity, eg:pituitary diseases, hypothalamic disorder, hypothyroidism, pancreatic diseases，hyperadrenocorticism, postmenopausal obesity etc.
- The individuals with server cardiovascular and cerebrovascular diseases and cancer.
- Having therapy for obesity in the last three months.
- The individuals do not adhere to the treatment or are with other treatments.
- Female individuals with pregnancy, lactation and planning a pregnancy in the two months.
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 |
|---|---|---|
| acupunctureZhong-wan (RN12), Liang-men (ST21), Shui-fen (RN9) and Qi-hai (RN6) and bilateral acupuncture points Dai-mai (GB26), Tian-shu (ST25), Zu-sanli (ST36), Feng-long(ST40) and Liang-qiu(ST34) will be applied through the skin by acupuncture for 30 minutes every time. Electro-acupuncture apparatus will be connected to both Dai-mai, Zu-sanli and Feng-long, Zhong-wan and Qi-hai for 30 minutes with interrupted waves (2/100HZ). | Device | intervention group |
Primary outcome
body mass index(BMI)
Time frame: 2 month after treatment
6 secondary outcomes
waist-to-hip ratio (WHR)
Time frame: 2 month after treatment
Blood sugar
Time frame: 2 month after treatment
Total cholesterol
Time frame: 2 month after treatment
Triglycerides
Time frame: 2 month after treatment
High-density lipoprotein cholesterol
Time frame: 2 month after treatment
Low-density lipoprotein cholesterol
Time frame: 2 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Sun Zhongren principal investigator
First Affiliated Hospital of Heilongjiang Chinese Medicine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Obesity and Overweight, run by Heilongjiang University of 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 5 inclusion and 7 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 26 Mar 2015. 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 Xie Ning, PhD (086 045182111401, xiening2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index(BMI) (time frame: 2 month after treatment). 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 26 Mar 2015.