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The clinical study for the evaluation of the efficacy and safety of YY-312(Herbal extract composition; Evodiae fructus, Imperatae rhizome and Citrus unshiu markovich) on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial

The clinical study for the evaluation of the efficacy and safety of YY-312 on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001225
Enrollment
60
Registered
2014-09-15
Start date
2014-04-08
Completion date
Unknown
Last updated
2019-03-11

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 : Subjects will be randomized to receive YY-312 1,800mg or placebo. Subjects will orally self-adminster YY-312 1,800mg or placebo, 3 capsules twice per day for 12 weeks.

Sponsors

Yuyu Phama
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male and female subjects between 19-60years of age inclusive. 2) BMI of 25.0 - 30.0kg/m2 3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion criteria

Exclusion criteria: 1) Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue 2) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL 3) Subjects with endocrinopathy or abnormal screening TSH(Thyroid-Stimulating Hormone) value(=0.1uU/ml or =10 uU/ml) 4) Subjects with hyperlipidemia) (fasting triglycerides > 600mg/dl) 5) Serum AST(aminotransferse)/ALT(alanine amintransferse) = 3 times the upper limit of normal 6) Serum creatinine = 1.5 times the upper limit of normal 7) Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon 8) Subjects with taking drugs that can affect the body weight within the 3 months 9) Subjects with clinically significant cardiovascular disease within the 6 months prior to screening 10) Subjects who change weight more than 4kg within 4 months 11) Subjects with pancreatopathy 12) Subjects with chronic malabsorption syndrome or bile secretion disorder 13) Subjects with undergoing gastrointestinal operation for reducing boy weight 14) Subjects with postoperative intestinal adhesion 15) Subjects with a history of cancer and intervention within the 5 years prior to screening 16) Subjects with a history of CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction) 17) Subjects with heart disease, kidney disease, liver disease, lung disease and cerebrovascular disease 18) Subjects with gallbladder diseases, gastrointestinal diseases, gout and porphyria 19) Subjects with asthma and allergic disease 20) Subjects with bulimia and abuse of relievers 21) Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period 22) Woman who are pregnant or lactating 23) Participation in any clinical trial within the 1 month prior to screening. 24) Subjects who could affect preclude evaluation of response in the opinion investigator

Design outcomes

Primary

MeasureTime frame
Fat percentage(by DEXA) ;Fat mass(by DEXA)

Secondary

MeasureTime frame
Body weight;Waist circumference

Countries

Korea, Republic of

Contacts

Public ContactMiyoung Lee

Inje University Seoul Paik Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 26, 2026