Evaluating the Safety and Efficacy of HP001 on Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Kyunghee University Medical Center
Sponsor:
Collaborators:
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01724099
First received: November 2, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

The hypothesis of this study is obese patient with HP001 for 12 weeks will show a superior reduction compared to those taking the placebo.


Condition Intervention Phase
Obesity
Drug: HP001
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of HP001 on Obese Patients

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: between baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C-reactive protein (CRP) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: Yes ]
  • Blood glucose [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Waist/hip ratio [ Time Frame: 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • Korean Obesity-related Quality of Life scale [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Korean version of Eating Attitudes Test-26 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Triglyceride [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Visceral fat area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Using abdominal computed tomography

  • Subcutaneous fat area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Using abdominal computed tomography


Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HP001
powder type, 3 times per day before the meal, 12 weeks total
Drug: HP001
Korean medicinal herbal drug
Placebo Comparator: Placebo
powder type, 3 times per day before the meal, 12 weeks total
Drug: Placebo
Placebo drug, same odor and formula as HP001

Detailed Description:

This study has two arms, HP001 and placebo group. Inclusion of 80 patient each arm. They will be screened at first visit. At the baseline, that is the second visit, they will be evaluated each outcomes including weight, waist circumference, lipid profile (total cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and eating attitudes, etc. The HP001 will provide to the patients from the baseline, it contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be repeated except lipid profile, CRP, abdominal CT. Another HP001 of 4 weeks will be given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes, etc.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged 18-65 years old
  2. Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8mmol/L(140mg/dL) 2.4. BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening
  3. Agreed to low-calorie diet during the trial
  4. Written informed consent of the trial

Exclusion Criteria:

  1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
  2. Heart disease (heart failure, angina pectoris, myocardial infarction)
  3. Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg)
  4. Malignant tumour or lung disease
  5. Cholelithiasis
  6. Severe renal disability (SCr > 2.0 mg/dL)
  7. Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
  8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
  9. Narrow angle glaucoma
  10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
  11. History of stroke or temporary ischemic cardioplegia
  12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
  13. Use of medication that could have effect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having effect on absorption, metabolism, excretion)
  14. Use of β--blocker or diuretic as hypertension medication within last 3 months
  15. Use of medication for central nervous system or central active weight reduction medication
  16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  17. Difficult to measure anthropometric dimensions because of anatomical change such as resection
  18. Surgical history for weight reduction; bariatric surgery, etc.
  19. Unable to follow instructions of the trial as judged by investigator
  20. Women who were pregnant, lactating, planning a pregnancy or women of childbearing age who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.)
  21. Use of other investigational product within last 1 month
  22. Reduction over 10% of the previous weight within 6 months
  23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724099

Contacts
Contact: Seong-gyu KO, KMD 82-2-961-9278 khuksg@gmail.com

Locations
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Yoon-kyung SONG, Doctor    070-7120-5046    oxygen@korea.com   
Principal Investigator: Yoon-kyung SONG, KMD         
Sponsors and Collaborators
Kyunghee University Medical Center
Korea Health Industry Development Institute
Gachon University Gil Medical Center
Investigators
Principal Investigator: Yoon-kyung SONG, KMD Gachon University Medical Center
  More Information

No publications provided

Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01724099     History of Changes
Other Study ID Numbers: HP001
Study First Received: November 2, 2012
Last Updated: November 8, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
Obesity
Herbal product
Korean Medicine

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014