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Obese WomenPhase 4NCT02276235

The Therapeutic Effect of Catgut Embedding in Obesity

A Phase 4 study testing Catgut embedding group in people with Obese Women, run by Taipei City Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women. Read more about this study

Who is it for?
Ages 20 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obese Women
What is being tested?
Catgut embedding group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteTaiwan
Study dates
Jan 2014to Dec 2014
Phase
Phase 4
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 20 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • body mass index (BMI) ≥ 27 kg/m2 waist circumference (WC) ≥ 80 cm and willing to participate in and fill out the questionnaires for this trial.

Who cannot join

  • Endocrine disease(Thyroid disease, pituitary disease, diabetes mellitus) Autoimmune disease（SLE、SSS、RA） Heart disease(Heart failure, arrhythmia etc.） Abnormal liver function（GOT>80U/L、GPT>80U/L） Abnormal kidney function（serum creatinine>2.5 mg/dL） Stroke disease in past one year Under breast feeding or pregnancy Coagulation disorder Subjects with keloid disorder Accept weight reduction treatment in last two months

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Branch of Chinese Medicine, Taipei City Hospital

    Taipei, Taiwan, 886

Other trials in Taiwan

About this study

Official title: The Therapeutic Effect of Catgut Embedding in Obesity-A Randomized, Double-blind, Placebo-controlled Clinical Trial

The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women.

Read the detailed description

We will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(BMI) 27㎞/㎡ and waist circumference≧80cm. After inform consent, they will be randomly assigned into two groups. In group A, catgut embedding will be applied to six acupuncture points on the abdomen including Qihai (Ren-6), Shuifen (REN-9), bilateral shuidao (ST-28) and Siman (ST-26), which have been proved to be effective on obesity in our previous study, once each week for six times. In group B, sham catgut embedding will be applied on the same acupoints once each week for six weeks. This trial will go on for six weeks with six course of treatment.

Our primary outcome measurements is complexion which included body mass index(BMI),waist circumstances, and waist-hip ratio. In our second outcome measurments, we will evaluate the life quality of these patients using 12-Item Short Form Health Survey (SF-12) which developed for the Medical Outcomes Study (MOS) and also using questionnaire of quality of life that was designated by World Health Organization. We will also classify the patients by questionnaire designed for TCM syndrome of obesity. We will check blood test included lipid profile (TG, Chol, HDL-C, LDL-C), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. Each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women.

Conditions
Obese Women
Being tested
Catgut embedding group, sham catgut embedding group
Keywords
catgut embedding, obese women, obesity-related hormones

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catgut embedding groupDevice

    Also called acupoint catgut embedding

    An extensive form of acupuncture that involves weekly infixing self-absorptive chromic catgut sutures into acupoints with a specialised needle under antiseptic precautions. The catgut then stimulate those points over a long period. The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger with chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below.

    Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)

  • sham catgut embedding groupDevice

    Also called sham acupoint catgut embedding

    The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below.

    Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)

Study groups in NCT02276235
Study groupRoleWhat they receive
catgut embedding groupExperimentalCatgut will be embedding in acupoints as below. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) Frequency: one time per week Duration: 6 weeks
Receives: Device: Catgut embedding group
sham catgut embedding groupSham comparatorThe stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. All the procedure will be performed as in catgut embedding group. Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26) The other procedure were the same as catgut embedding group Frequency: one time per week Duration: 6 weeks
Receives: Device: sham catgut embedding group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight

    Measured: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

  2. body mass index

    Measured: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

  3. waist circumference

    Measured: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

  4. hip circumference

    Measured: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks

Secondary outcomes (11)

  1. cholesterol

    cholesterol (Chol),

    Measured: Assess at baseline and after 6 weeks of treatment

  2. triglyceride (TG)

    triglyceride (TG),

    Measured: Assess at baseline and after 6 weeks of treatment

  3. low-density lipoprotein cholesterol (LDL-C)

    low-density lipoprotein cholesterol (LDL-C)

    Measured: Assess at baseline and after 6 weeks of treatment

  4. High-density lipoprotein cholesterol(HDL-C)

    High-density lipoprotein cholesterol(HDL-C)

    Measured: Assess at baseline and after 6 weeks of treatment

  5. Quality of life

    short-form 12 items and WHOQOLBREF

    Measured: Assess at baseline and after 6 weeks of treatment

  6. Questionnaire on traditional Chinese medicine syndrome groups

    Obesity subjects will be classified into six groups including stomach heat, yin deficiency, qi stagnation, qi deficiency, kidney deficiency and blood stasis With more than two "yes"in items, patient will be classified to that kind of syndrome

    Measured: Assess at baseline and after 6 weeks of treatment

  7. sugar

    AC sugar,

    Measured: Assess at baseline and after 6 weeks of treatment

  8. glycohemoglobin

    glycohemoglobin (HbA1c),

    Measured: Assess at baseline and after 6 weeks of treatment

  9. liver function

    ALT

    Measured: Assess at baseline and after 6 weeks of treatment

  10. kidney function

    Cr

    Measured: Assess at baseline and after 6 weeks of treatment

  11. inflammatory markers

    hsCRP

    Measured: Assess at baseline and after 6 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276235
Sponsor's protocol ID
101XDAA00024
Status last verified
Oct 2014
First submitted
14 Oct 2014
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Huang CY, Choong MY, Li TS. Treatment of obesity by catgut embedding: an evidence-based systematic analysis. Acupunct Med. 2012 Sep;30(3):233-4. doi: 10.1136/acupmed-2012-010176. Epub 2012 Jul 7. No abstract available.

    PubMed 22773366

  • Liao JQ, Song X, Chen Y, Liang LC, Wang SX. [Clinical randomized controlled trials of acupoint catgut-embedding for simple obesity: a meta-analysis]. Zhongguo Zhen Jiu. 2014 Jun;34(6):621-6. Chinese.

    PubMed 25112111

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Catgut embedding group in people with Obese 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 1 inclusion and 1 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 28 Oct 2014. 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. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

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?

body weight (time frame: assessed at each time before procedures and one week after the 6th treatment, an expected average of 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276235, which also lists 2 linked publications.

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 28 Oct 2014.

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