Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Ayurswasthya Yojana, Centre of excellence Scheme, Ministry of Ayush, Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: i. Subjects of either sex aged between 18-70 years. ii. Newly diagnosed or drug naïve (in the preceding 3 months) known subjects of diabetes with HbA1c 7-9.0 % (both values inclusive) iii. Subjects who submit a written informed consent form.
Exclusion criteria
Exclusion criteria: i. Subject diagnosed with type 1 Diabetes Mellitus. ii. Subjects with Type-2 Diabetes who are on any type of Anti-hyperglycemic agents in the past 3 months iii. Subjects with Haemoglobin percentage less than 10 g/dl iv. Subjects with uncontrolled hypertension (with or without medication more than 160/100 mmHg after 10 minutes of rest) v. Subjects with recent (less than 6 months) acute coronary syndrome, PTCA, CABG, CVA or any other major acute Cardiovascular event or intervention vi. Subjects with recent (less than 6 months) major surgical procedure vii. Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) viii. Subjects with Renal Dysfunction (defined as eGFR less than 60 ml/min. calculated by CKD-EPI eGFR calculator 2021) ix. Subjects with Hypothyroidism or Hyperthyroidism currently not euthyroid on therapy x. Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids xi. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy xii. Pregnant / Lactating women xiii. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy xiv. Subjects with current diagnosis of malignancy or in last five years xv. Subjects suffering from major systemic illness necessitating long term drug treatment (defined as more than 3 months) xvi. Subjects who have completed participation in any other clinical trial during the past three months xvii. Any other condition which the Investigator thinks may jeopardize the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) from baseline to 12 weeks & 24 weeks.Timepoint: baseline to 12 weeks & 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Change in blood glucose levelsTimepoint: baseline to 12 weeks & 24 weeks.;ii. Change in Plasma Insulin levelsTimepoint: baseline & end of 24 weeks;iii. Change in HOMA IR, HOMA%B, HOMA%STimepoint: baseline & end of 24 weeks;iv. Change in Lipid profileTimepoint: baseline to 12 weeks & 24 weeks.;v. Change in Renal function (Sr. Creatinine, Cystatin-C, e-GFR and Urine Albumin- creatinine ratio)Timepoint: baseline to 12 weeks & 24 weeks.;viii. Change in Hs-CRPTimepoint: baseline & end of 24 weeks;ix. Change in SymptomsTimepoint: baseline and at 12 weeks and 24 weeks.;x. Change in QOLIDTimepoint: baseline to 12 weeks & 24 weeks.;xi. Changes in the Gut microbiome in selected subjectsTimepoint: baseline and 24 weeks;xii. Any SAE /ADRTimepoint: at any time during the study and till 1 month after end of study (EOS) visit. | — |
Countries
India
Contacts
Public ContactDr Kavya N
Central Ayurveda Research Institute
Outcome results
None listed