Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: 30 ml liquid of Trikara Madhusanyam Ras: Orally in morning and evening, 30 minutes before meal with 100 mL water.
Control Intervention1: Group B (Placebo): 30 ml liquid of Placebo: Oral
Sponsors
HAS HERBAL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants between age 30-65 years (both inclusive);2. Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (alone or combination) and ready to change the current course of treatment;3.Glycated haemoglobin (HbA1c) greater than and equal to 6.5 percent and less than and equal to 10 percent (both inclusive);4. Fasting Plasma Glucose (FPG) greater than and equal to 130 mg per dL and less than and equal to 250 mg per dL (both inclusive);5. Participants willing to comply with the study procedure and sign written informed consent;6.Participants with a BMI of more than 28 and less than 35 kg per m2; 7.Participants with or without deranged lipid profile.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes; 2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including insulin treatment; 3.Participants with concurrent serious hepatic dysfunction (defined as AST and or ALT greater than 3 times of the upper normal limit) or renal dysfunction (defined as S. creatinine greater than 1.4 mg per dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) or other concurrent severe disease; 4.Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (greater than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment; 5. Smokers or alcoholics and or drug abusers; 6. Participants with evidence or history of malignancy; 7. Involvement in any other clinical trial requiring drug therapy; 8. Pregnant or lactating women or women of fertile age not using effective contraception; 9. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in glycemic profile by assessing a) Fasting, and post-meal plasma glucose levels from screening to the end of the study and b) HbA1c levels at screening and end of the study. Changes in insulin resistance by assessing fasting insulin, HOMA-IR score at screening and end of the study.Timepoint: screening, baseline, day 30, day 60 and day 90(end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in lipid profile by assessing total cholesterol, LDL, HDL, Triglycerides etc., at screening and end of the study. 2.Changes in antidiabetic medication from screening to end of the study. Changes in anthropometric parameters like body weight, BMI, and waist circumference from screening to end of the study.Timepoint: screening, baseline, day 30, day 60 and day 90(end of the study) | — |
Countries
India
Contacts
Public ContactMr Abhishek Birla
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed