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A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of ALM16 on reducing body weight and body fat of overweight or obesity subjects

A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of ALM16 on reducing body weight and body fat of overweight or obesity subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004947
Enrollment
80
Registered
2020-04-21
Start date
2020-05-08
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Consumption of placebo or combined extract of Astragalus membranaceus Bunge .Lithospermum erythorhizon Siebold et Zuccarini , once a day for 12 weeks ( 480mg/day)

Sponsors

Dong Il Pharmtec
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 20 years= Age = 60years 2) 25kg/m^2= BMI <32kg/m^2 3) Subject who voluntarily agree to participate and signs informed consent form

Exclusion criteria

Exclusion criteria: 1) Subjects with severe cerebrovascular disease, cardiac disease (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) within recent 6 months 2) Subjects for uncontrolled hypertension(systolicBP = 160 mmHg or diastolicBP = 100 mmHg) 3) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL 4) Subjects with TSH(thyroid-stimulating hormone) = 0.1 uIU/ml or = 15 uIU/ml 5) Subjects with Creatinine = 2 times the upper limit of normal 6) Subjects with AST or ALP = 3 times the upper limit of normal 7) Subjects with complaint of severe gastrointestinal symptoms such as heartburn, dyspepsia 8) Subjects who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, health functional food for diet, antidepressants, ß- blocker, diuretics, contraceptives, steroid, and female sex hormone) within recent 1 months 9) Participation in commercial diet program within the 3 months prior to screening 10) Participation in any clinical trial within the 1 month prior to screening or have a plan to participate in other clinical trial 11) Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system 12) Subjects with the musculoskeletal disorders or restricted physical activity 13) Women who are pregnant of lactating or planning to pregnant 14) Subjects which in the opinion investigator could affect preclude evaluation of response

Design outcomes

Primary

MeasureTime frame
Whole body fat percentage by Dual Energy X-ray Absorptiometry

Secondary

MeasureTime frame
Body weight;Brachial circumference, Femoral circumference, Waist circumference, Hip circumference, Waist-hip ratio(WHR);Body mass index(BMI);Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT);Basal metabolism rate;Blood Lipid;hs-CRP, Adiponectin, Leptin

Countries

Korea, Republic of

Contacts

Public ContactJUNG SOOK

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026