Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: DB 07: DB 07 is an amalgamation of 21 herbs. 15 ml of IP to be taken orally twice daily with equal quantity of water after food for 90 days.
Control Intervention1: NA: NA
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged between 30 - 70 years with BMI between 18 and 33 kg/m2. 2.Subjects diagnosed with the type 2 diabetes mellitus based on the physical, medical and laboratory assessments (fasting plasma glucose >126mg/dL 6.5% and poorly controlled glycemic status (200mg/dL to 3.Subjects on life style modifications with allopathic anti-diabetic therapy namely biguanides (metformin) and sulfonylureas (2nd/3rd Generation). 4.Subjects who are willing to maintain a diet plan applicable for diabetic subjects during the course of the study. 5.Subjects should be active; considered generally healthy as per health history and routine clinical investigations. 6.Ability to understand the risks and benefits of the protocol. 7.Subjects who provide written informed consent and agree to be available for regular follow up throughout the study duration.
Exclusion criteria
Exclusion criteria: 1.Subjects with clinical history of severe endocrine disorders which according to the physician might interfere with the trial medication 2.Subjects suffering from Type 1 Diabetes mellitus or patients diagnosed with type 2 diabetes mellitus receiving insulin, or subjects with poorly controlled glycemic status with HbA1c >9% and/or have severe complications of diabetes mellitus viz., neuropathy, nephropathy, retinopathy Subjects with concurrent serious hepatic dysfunction (defined as AST and/or ALT >3 times of upper normal limit) or renal dysfunction (defined as S. creatinine >1.2mg/dL),or uncontrolled pulmonary dysfunction (asthmatic and Chronic obstructive pulmonary disease (COPD) patients), subjects with known conditions like HIV or any other concurrent severe disease. 3.Subjects having a history stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months. 4.Subjects with the history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 5.Subjects consuming alcohol ( >2 standard drinks per week) or smoking ( >5 cigarettes a day), and who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products. 6.Subjects who underwent major surgical procedures in last 6 months. 7.Pregnant/lactating women; subjects on steroids, oral contraceptive pills or oestrogen replacement therapy 8.Evidence of malignancy; suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, psycho-neuro-endocrinal disorders, etc 9.Subject who has illness as per the opinion of investigator which would interfere to participate into the study. 10.H/O hypersensitivity to any of the trial drugs or their ingredients and subjects who participated in a clinical study within the last 180 days prior to recruitment or currently involved in another study, or other conditions as per the Investigator may jeopardize the study will be excluded from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to end of the study period in: 1.Fasting Blood Sugar level (FBS) 2.Post-prandial blood sugar (100-120 minutes after breakfast) Timepoint: Change from Baseline to end of the study period in: 1.Baseline, Day 1, Day 30, Day 60, and Day 90 2.Baseline, Day 1, Day 30, Day 60, and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to the end of the study period in: 1.Change in glycosylated hemoglobin (HbA1c level) 2.Change in symptoms- Scale of Diabetic symptoms (will be measured by Visual Analog Scale) 3.Clinical Global Impression Scale Timepoint: 1.Baseline, and Day 90th 2.Baseline, Day 1, Day 30th, Day 60th,and Day 90th 3.Day 90th | — |
Countries
India
Contacts
Public ContactMr Dheeraj Deep
Emami Ltd
Outcome results
None listed