Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
None listed
Sponsors
Ministry of AYUSH Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed drug naïve pre-diabetic subjects with HbA1c of 5.7- 6.4%. (Both values inclusive) 2. Subjects who submit a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject diagnosed with type 1 or type 2 Diabetes Mellitus. 2. Subjects who have been administered with any type of Anti-hyperglycaemic agents (OHA or injectable). 3. Subjects with Haemoglobin percentage 4. Subjects with uncontrolled hypertension (with or without medication >140/90mmHg after 5 mins of rest) 5. Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease. 6. Pregnant / Lactating women. 7. Any other condition which the Investigator thinks may jeopardize the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) from baseline and at 12 weeks.Timepoint: Change in Glycosylated Hemoglobin (HbA1c) from baseline and at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Post prandial blood sugar (2 hours after breakfast) from baseline and at 12 weeksTimepoint: at baseline, 4th week, 8th week and 12th week;Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ)Timepoint: at baseline, 4th week, 8th week and 12th week;change in symptoms, Ayurveda symptoms questionnaire (ASQ)Timepoint: at Baseline and 12th week;Any SAE /ADR or change in laboratory parametersTimepoint: at baseline, 4th week, 8th week and 12th week;Change in BMI and waist circumferenceTimepoint: at baseline, 4th week, 8th week and 12th week.;Change in Fasting blood sugar (min 8 hrs after dinner) from baseline and at 12 weeksTimepoint: at baseline, 4th week, 8th week and 12th week;Change in Lipid profileTimepoint: at baseline and 12th week | — |
Countries
India
Contacts
Public ContactDr Amulya Kannan
Central Ayurveda Research Institute
Outcome results
None listed