A Double-blind, Randomized, Placebo-controlled Intervention Study of the Efficacy and Safety of “ID1216“ in the Overweight Subject

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000836

Enrollment

Registered

2013-09-05

Start date

2013-09-24

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 polygonatum sibiricum 2.0g or placebo. Subjects will orally self-adminster polygonatum sibiricum or placebo bid, 2 capsules twice per day fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female subjects between 20-60years of age inclusive. 2) BMI of 25.0-29.9kg/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)Clinically significant abnormality reaction in the history of investigational drugs or health functional food. 2)Have a gastrointestinal disease history that can affect drug absorption (Crohn’s disease) or surgery (except simple appendectomy or hernia surgery) 3)Defined by the following laboratory parameters: - AST, ALT = 2 times the upper limit of normal. 4)Defined by the following clinical disease: -Subjects who use of beta blocker or hydragogue -Subjects with diabetes (use of hypoglycemic agent or insulin) -Subjects with endocrinopathy or abnormal screening TSH value -Subjects with medical conditions, including depression, schizophrenia, psychosis, alcohol abuse and drug abuse -Subjects with clinically significant cardiovascular disease (heart failure, angina pectoris, myocardial infarction, etc.) -Subjects with clinically significant liver disease (Hepatitis B, Hepatitis C, Liver cancer, etc.) 5)Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon. 6)Woman who are pregnant or lactating. 7)Subjects who are registered on the other clinical research within 1 month before enroll. 8)An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.

Design outcomes

Primary

Measure	Time frame
Body weight	—

Secondary

Measure	Time frame
Fat mass(by DEXA);Fat distribution(by CT);Body mass index(BMI);waist circumference ;waist-hip ratio(WHR)	—

Countries

Korea, Republic of

Contacts

Public ContactYunjung Choi

Inje University Seoul Paik Hospital

Outcome results