prediabetes prediabetes, fasting plasma glucose, insulin, Andrographis paniculata
Conditions
Interventions
31 volunteers will be randomized to receive Andrographis paniculata extract capsules at daily dose of 40 mg/day (10 mg / cap, 2 capsules x twice a day, after meal) for 12 weeks.,31 volunteers will be
Experimental Dietary Supplement,Placebo Comparator No treatment
Andrographis paniculata extract capsule,placebo capsule
Sponsors
Agricultural Research Development Agency (ARDA)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Thai male or female aged between 18-70 years. 2. subjects with prediabetes diagnosis determined by fasting plasma glucose between 101-125 mg/dL and HbA1c from 5.7% - 6.4%. 3. Agree to refrain from alcohol consumption and smoking for at least one week prior to participation in the research and throughout the study period. 4. subjects who agree to continue with current diet and refrain from taking any other dietary supplements (as advised by the research physician) during the study. 5. subjects who agree to continue the regularly exercising and normal physical activity level during study period.
Exclusion criteria
Exclusion criteria: 1. Current daily use of any oral hypoglycemic drugs or insulin injection. 2. Elevated liver enzymes or abnormal renal function at baseline. 3. Current daily use of drug-induced glucose alterations (e.g. prednisolone). 4. Pregnancy or lactation. 5. Volunteers with a history of allergy to Andrographis paniculata or its extracts. 6. Volunteers with active cancer. 7. Volunteers deemed unsuitable for participation by the research physician due to health risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 6 (Fasting Plasma glucose, HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver enzymes pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 6 (AST, ALT),Kidney functions pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 6 (S-creatinine, S-BUN),Lipid profiles pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 6 (Triglyceride, Cholesterol, HDL, LDL) | — |
Countries
Thailand
Contacts
Public ContactJutamaad Satayavivad
Chulabhorn Research Institute
Outcome results
None listed