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Metabolic SyndromePhase 4NCT02651454

A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -

A Phase 4 study testing Daesiho-tang and Chowiseungcheng-tang in people with Metabolic Syndrome and Obesity, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Metabolic Syndrome, Obesity
What is being tested?
Daesiho-tang and Chowiseungcheng-tang
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSouth Korea
Study dates
31 Dec 2015to 2 Dec 2020
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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female aged 18 to 65 years
  • Subject must included at least one or more of the following symptoms below
  • BMI of 30 kg/㎡ or more;
  • BMI between 25 and 29.9kg/㎡ with hypertension, taking medication or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit
  • BMI between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
  • BMI between 25 and 29.9kg/㎡ with hyperlipidemia, taking medication or total cholesterol ≥ 200mg/dL or Triglyceride ≥ 150mg/dL at screening visit
  • Agreed to low-calorie diet during the trial
  • Written informed consent of the trial

Who cannot join

  • Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
  • Heart disease (heart failure, angina pectoris, myocardial infarction)
  • Cholelithiasis
  • Severe renal disability (SCr > 2.0 mg/dL)
  • Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
  • History of narrow angle glaucoma
Show all 17Show fewer
  • History of stroke or temporary ischemic cardioplegia
  • History of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
  • Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
  • Use of CNS stimulant medication for weight loss
  • Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  • history of weight loss surgery, such as bariatric surgery, etc.
  • Subjects who are judged to be inappropriate for the clinical study by the researchers
  • Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.)
  • Use of other investigational product within last 1 month
  • 10 percent reduction in body weight over 6 months
  • Decided to quit smoking over the last 3 months or have irregular smoking habits

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Gachon University Gil Oriental Medical Hospital

    Incheon

Other trials in South Korea

About this study

The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors

Being tested
Daesiho-tang, Chowiseungcheng-tang, Placebo
Keywords
metabolic syndrome, Daesiho-tang, Taeeumjowi-tang, Korean medicine
Medical subject headings
Metabolic Syndrome, Obesity

What participants receive

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

  • Daesiho-tangDrug

    Also called DSHT, Elsion Granule

    Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

  • Chowiseungcheng-tangDrug

    Also called CST

    Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.

  • PlaceboDrug

    Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Study groups in NCT02651454
Study groupRoleWhat they receive
Daesiho-tangExperimentalDose: 6g, three times a day, each taken before or between meals for 12 weeks
Receives: Drug: Daesiho-tang
Jowiseungcheung-tangExperimentalDose: 6g, three times a day, each taken before or between meals for 12 weeks
Receives: Drug: Chowiseungcheng-tang
PlaceboPlacebo comparatorDose: 6g, three times a day, each taken before or between meals for 12 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Changes from baseline in body weight

    Measured: baseline, 12 weeks

Secondary outcomes (11)

  1. Changes from baseline in body fat percentage

    Measured: baseline, 4,8,12,16 weeks

  2. Changes from baseline in fat mass

    Measured: baseline, 4,8,12,16 weeks

  3. Changes from baseline in Waist circumference

    Measured: baseline, 4,8,12,16 weeks

  4. Changes from baseline in Waist/hip ratio

    Measured: baseline, 4,8,12,16 weeks

  5. Changes from baseline in Body mass index

    Measured: baseline, 4,8,12,16 weeks

  6. Changes from baseline in Lipid profile

    Measured: Screening visit, 12 weeks

  7. Changes from baseline in C-reactive protein (CRP)

    Measured: Screening visit, 12 weeks

  8. Changes from baseline in blood glucose

    Measured: Screening visit, 12 weeks

  9. Changes from baseline in abdominal visceral fat area

    Measured: baseline, 12 weeks

  10. Korean Obesity-related Quality of Life (QoL) scale

    Measured: baseline, 12 weeks

  11. Korean version of Eating Attitudes Test-26

    Measured: baseline, 12 weeks

Timeline

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

  1. First posted11 Jan 2016 (estimated)
  2. Study start31 Dec 2015
  3. Primary completion2 May 2020
  4. Study completion2 Dec 2020

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651454
Sponsor's protocol ID
ISEE_2015_OBESITY
Status last verified
Apr 2021
First submitted
5 Jan 2016
Last updated
12 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Kim HJ, Ko Y, Kim H, Cha YY, Jang BH, Song YK, Ko SG. A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors: Double blinded, randomized, multicenter, placebo controlled study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(5):e18955. doi: 10.1097/MD.0000000000018955.

    PubMed 32000419

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daesiho-tang and Chowiseungcheng-tang in people with Metabolic Syndrome and Obesity, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.

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 12 Apr 2021. 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 South Korea. 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?

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?

Changes from baseline in body weight (time frame: baseline, 12 weeks). 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 NCT02651454, which also lists 1 linked publication.

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 12 Apr 2021.

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