Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
Intervention1: Gymnema extract (Melitwocut ): Dose :500mg, Doasge form: Capusle, 1 capsule 15 minutes before breakfast and dinner , Total Duration 84days
Control Intervention1: Placebo: Dose :500mg, D
Sponsors
CELL GREEN BIOLAB Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female subjects aged between 20 and 65 years (both inclusive). 2. Individuals those in the prediabetic range (fasting blood glucose 100 to 125 mg per dL and postprandial blood glucose 140 to 199 mg per dL) who are not taking medication. 3. Subjects who are willing to provide informed consent and participate in the study.
Exclusion criteria
Exclusion criteria: 1. Individuals with drug dependence. 2. Individuals who have been administered hypoglycemic agents within the past 3 months. 3. Individuals with abnormal thyroid function. 4. Individuals with gastrointestinal dysfunction. 5. Individuals with congenital deficiency of sugar-degrading enzymes. 6. Individuals with lipid metabolism disorders and those with acute or chronic inflammation 7. Individuals with cardiovascular diseases such as heart failure, myocardial infarction or stroke. 8. Pregnant or lactating women or those planning to become pregnant. 9. Individuals with allergies or adverse reactions to the investigational product. 10. Individuals consuming alcohol males greater than or equal to 40 g per day females greater than or equal to 20 g per day (according to WHO daily alcohol intake standards) 11. Heavy smokers- greater than or equal to 20 cigarettes per day 12. Individuals who used any pharmacological treatment, medicinal herb, or supplement during the previous 3 months which has effect on study parameters will be excluded. 13. Individuals who have participated in another clinical trial within the past 3 months. 14. Individuals deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Blood Sugar Level Tests-Fasting blood sugar (FBS) & Post prandial blood sugar (PPBS) 2. Glycated hemoglobin (HbA1c) 3. Oral Glucose Tolerance Test (OGTT)Timepoint: Screening visit, Day 42,Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.HOMA-IR score (Screening visit, Day 42,Day 84) 2.Serum Insulin levels 3.Serum Adiponectin levels 4.C-Peptide test 5.Safety assessments-Biochemistry, Hematology (CBC) LFT & RFT, Lipid profile(Screening visit and Day 84)Timepoint: Day0,Day 42,Day 84 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed