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ObesityNCT03479346

Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors - A Study Protocol for a Double-blind, Randomised, Multi-center, Placebo-controlled Clinical Trial

A study testing GGT in people with Obesity and Metabolic Syndrome, 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 GGT on Korean obese Women with or without metabolic syndrome Risk factors Read more about this study

Who is it for?
Ages 19 to 65 years, women only
Conditions the study is for
Obesity, Metabolic Syndrome
What is being tested?
GGT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteSouth Korea
Study dates
28 Apr 2018to 1 Dec 2020
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 19 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female aged 19 to 65 years
  • Subject must included at least one or more of the following symptoms below;
  • BMI of 30 kg/㎡ or more;
  • BMI between 27 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
  • BMI between 27 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

  • Subjects who had experience with allergic reaction on investigational drug(any ingredients of IP)
  • Subjects who has diabetes as comorbidity, had experienced the elevation of blood glucose by ephedrine
  • Subjects who had experienced rash, rubefaction, or itchiness by GGT administration
  • Subjects who usually feel fatigue due to hyperhidrosis
  • Subjects who experienced other allergic reactions
  • Subjects who had 10 percent reduction in body weight over 6 months
Show all 30Show fewer
  • Subjects who decided to quit smoking over the last 3 months or have irregular smoking habits
  • Subjects who have endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
  • Subjects who have heart disease (heart failure, angina pectoris, myocardial infarction)
  • Subjects who have uncontrolled hypertension despite the use of antihypertensive drugs (SBP > 145 mmHg or DBP > 95 mmHg)
  • Subjects who have uncontrolled diabetes despite the use of drugs (FBS>7.8 mmol/L (140 mg/dL))
  • Subjects who have severe renal disability (SCr > 2.0 mg/dL)
  • Subjects who have severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase [ALP])
  • Subjects who have poor digestion(anorexia, stomach discomfort, nausea, vomiting etc) or have the history of eating disorder such as anorexia nervosa or bulimia nervosa, etc.(KEAT-26 < 20)
  • 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
  • Subjects who had a use of drugs that can increase blood pressure or heart rate within a week, such as, Decongestants, cough, cold, allergy treatments that include the ingredients of phenylpropanolamine, ephedrine, pseudoephedrine
  • Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  • Subjects who have diseases that may occur hypokalemia (hypomagnesemia, Bartter syndrome, Gitelman syndrome, diseases that can cause high aldosteronism etc.) or have cardiac dysrhythmia
  • Difficult to measure anthropometric dimensions because of anatomical change such as resection
  • History of weight loss surgery, such as bariatric surgery, etc.
  • Edema or dysuria
  • Malignant tumour or lung disease
  • Cholelithiasis
  • History of narrow angle glaucoma
  • Subjects who have nervous or psychological medical history or presently suffer from the following diseases: depression, manic disorder, bipolar disorder, schizophrenia, epilepsy, alcoholism, anorexia, hyperphagia, etc.
  • Subjects who have history of stroke or temporary ischemic cardioplegia
  • 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

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 GGT on Korean obese Women with or without metabolic syndrome Risk factors

Being tested
GGT, Placebo
Keywords
Obesity, Metabolic syndrome, Traditional Korean Medicine, Galgeun-tang
Medical subject headings
Obesity, Metabolic Syndrome

What participants receive

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

  • GGTDrug

    Also called Galgeun-tang

    Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

  • PlaceboDrug

    Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Study groups in NCT03479346
Study groupRoleWhat they receive
GGT groupExperimentalUsage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Receives: Drug: GGT
Placebo groupPlacebo comparatorUsage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
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

    Estimated mean changes from baseline in body weight after 12 weeks of treatment.

    Measured: baseline, 12 weeks

Secondary outcomes (15)

  1. Changes from baseline in body fat percentage

    Estimated mean changes from baseline in body fat percentage at different time points during treatment period

    Measured: baseline, 4,8,12 weeks

  2. Changes from baseline in fat mass

    Estimated mean changes from baseline in fat mass at different time points during treatment period

    Measured: baseline, 4,8,12 weeks

  3. Changes from baseline in Waist circumference

    Estimated mean changes from baseline in Waist circumference at different time points during treatment period

    Measured: baseline, 4,8,12 weeks

  4. Changes from baseline in Waist/hip ratio

    Estimated mean changes from baseline in Waist/hip ratio at different time points during treatment period

    Measured: baseline, 4,8,12 weeks

  5. Changes from baseline in Body mass index

    Estimated mean changes from baseline in Body mass index at different time points during treatment period

    Measured: baseline, 4,8,12 weeks

  6. Changes from baseline in Lipid profile

    Estimated mean changes from first visit in Lipid profile after 12 weeks of treatment.

    Measured: Screening visit, 12 weeks

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

    Estimated mean changes from baseline in C-reactive protein (CRP) after 12 weeks of treatment.

    Measured: baseline, 12 weeks

  8. Changes from baseline in blood glucose

    Estimated mean changes from first visit in blood glucose after 12 weeks of treatment.

    Measured: Screening visit, 12 weeks

  9. European Quality of life 5 Dimension(EQ5D)

    EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).

    Measured: baseline, 12 weeks

  10. Changes from baseline in serum leptin

    Estimated mean changes from first visit in serum leptin after 12 weeks of treatment.

    Measured: baseline, 12 weeks

  11. Korean version of Western Ontario and McMasters Universities Oateoarthritis Index

    Determination of patient's knee function and pain

    Measured: baseline, 12, 16 weeks

  12. cost per QALY(Quality Adjusted Life Years) gained

    The cost per QALY gained is calculated according to normal health-economic evaluation models.

    Measured: 6 months or 1 year

  13. Economic evaluation (medical costs)

    Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: baseline, 4,8,12,16,20,24 weeks

  14. Economic evaluation (time-related costs)

    Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: baseline, 4,8,12,16,20,24 weeks

  15. Economic evaluation (lost productivity costs)

    Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.

    Measured: baseline, 4,8,12,16,20,24 weeks

Timeline

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

  1. First posted27 Mar 2018
  2. Study start28 Apr 2018
  3. Primary completion1 Oct 2020
  4. Study completion1 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03479346
Sponsor's protocol ID
ISEE_2017_GGT
Status last verified
Apr 2021
First submitted
21 Mar 2018
Last updated
12 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GGT in people with Obesity and Metabolic Syndrome, 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 7 inclusion and 30 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.

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 NCT03479346.

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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