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Clinical Trials/KCT0000840
KCT0000840
Recruiting
N/A

The clinical study for the evaluation of the efficacy and safety of Monascus-fermentation (Monascus-fermented black bean) on reducing body weight of overweight or obese subjects

Inje University Seoul Paik Hospital0 sites60 target enrollmentTBD
ConditionsNot Applicable

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not Applicable
Sponsor
Inje University Seoul Paik Hospital
Enrollment
60
Status
Recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional Study
Sex
All

Investigators

Sponsor
Inje University Seoul Paik Hospital

Eligibility Criteria

Inclusion Criteria

  • 1\) Male and female subjects between 20\-65years 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

  • 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 value(\=0\.1uU/ml or \=10 uU/ml).
  • 4\. Serum AST/ALT \= 3 times the upper limit of normal.
  • 5\. Serum creatinine \= 2 times the upper limit of normal.
  • 6\. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
  • 7\. Subjects with clinically significant cardiovascular disease within the 6 months prior to screening.
  • 8\. Subjects with a history of cancer and intervention within the 5 years prior to screening.
  • 9\. Subjects with a history of CNS disorder(depressive disorder, schizophrenia, alcoholism, drug addiction).
  • 10\. Woman who are pregnant or lactating or women of childbearing age who are disagreed with effective contraceptions in the clinical trial period.

Outcomes

Primary Outcomes

Not specified

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