Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Yesaka Liquid: contains Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Eugenia jambolana, Picorhiza kurroa, Swertia chirata, Tinospora cordifolia, Gymnema Sylvestere, Cu
Sponsors
Simandhar Herbal Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from Type 2 Diabetes Mellitus for more than one year, and stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months. 2. Subjects having HbA1C value 7-11% (both inclusive) at screening. 3. Subjects having Fasting Plasma Glucose between 126 -252 mg/dl (both inclusive) at screening. 4. Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia and X- ray chest not showing any active lesion of tuberculosis. 5. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years post menopause. 6. Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects on insulin therapy. 2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type-2 3. Subjects with known history of chronic hepatic or renal disease. 4. Subjects with known history of active malignancy. 5. Subjects with known history of significant cardiovascular event 12 weeks prior to randomization. 6. Subjects with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 7. Subjects with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 8. Subjects with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 9. History of Use of any other investigational drug within 1 month prior to randomization 10. Known history of hypersensitivity to ingredients used in study drug 11. Pregnant and Lactating females. 12. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in HbA1C (Glycosylated Hemoglobin) value between the groups (Pre and post) 2. Monthly changes in WHOQOL over three months of the study treatment between the groups Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Monthly changes in BSL F and PP levels 2. Change in HOMA IR score 3. Change in fasting serum Insulin level 4. Monthly change in dose of OHAs 5. Monthly change in weight, BMI, waist circumference, Hip Circumference, waist: Hip ratio, BMR, Body fat percentage 6. Changes in clinical symptoms of Type 2 DM 7. Change in global assessment for overall change by the subject and investigator 8. Change in tolerability of study drugs 9. Change in Laboratory parameters and ECG. Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed