Health Condition 1: null- Type II Diabetes mellitus
Conditions
Interventions
Intervention1: TLPL/AY/04/2008: Each Film coated tablet contains Madhunashini extract (Gymnema sylvestre R.Br), Asana extract (Pterocarpus marcupium Roxb.), Amalaki extract (Emblica officinalis Gaertn
Sponsors
Tulip Lab 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 oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) for at least last 3 months. 2. Subjects having HbA1C value between 7-10% (both inclusive) at screening. 3. Subjects having Fasting Plasma Glucose 126-252 mg/dL (both inclusive) at screening. 4. Subjects of male gender or a nonpregnant, nonlactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal. 5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2. 6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides. 2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2. 3. Subjects having known hepatic or renal disease. 4. Subjects having an active malignancy. 5. Subjects giving history of significant cardiovascular event 6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 9. Use of any other investigational drug within 1 month prior to randomization 10. Known hypersensitivity to ingredients used in study drug 11. Pregnant and Lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of TLPL/AY/04/2008 in comparison with matching placebo as add-on therapy to OHA in patients suffering from type 2 Diabetes mellitus by assessing, 1.Changes in Fasting and Postprandial Plasma Glucose levels 2.Changes in HbA1C% Value Timepoint: Day 0, Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in fasting Serum insulin level 2.Reduction in dose of OHAs 3.Improvement in clinical symptoms of Type 2 DM 4. Global assessment for overall improvement by the subject 5. Global assessment for overall improvement by the investigator 6. Tolerability of study drugs assessment by study subject and investigator 7. Laboratory parameters like Liver function tests (LFT), renal function tests (RFT), Lipid Profile, Complete blood count (CBC), ESR, Hb% and Urine Examination Timepoint: Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Dileep Mane
Noble Hospital
Outcome results
None listed