Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Ratnaprash Sugarfree: Dabur Ratnaprash Sugarfree is a poyherbal formulation contains permissible alternate sweeteners instead of conventional sugar. It has to be taken one teaspoon foll
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / poly drug oral anti-diabetic therapy. 2. Subjects having HbA1c value below 8% at screening. 3. Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening. 4. Subjects in the age group of 18 to 70 years, both inclusive. 5. Subjects of female gender or non-pregnant, non-lactating females, . A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal. 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. 2. Known cases of Severe/Chronic hepatic or renal disease. 3. Known subject of any active malignancy. 4. Subjects giving history of significant cardiovascular event 5. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 6. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 7. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 8. Subjects using any other investigational drug within 1 month prior to recruitment 9. Known hypersensitivity to any of the ingredients used in study drug 10. Pregnant and Lactating females. 11. Subjects currently participating in any other Clinical study 12. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in HbA1c % (Glycosylated Hemoglobin %) levels. 2. Assessment of quality of life (QOL) on WHO QOL QuestionnaireTimepoint: 90 Days (3 Months) | — |
Secondary
| Measure | Time frame |
|---|---|
| To Assess changes in fasting & pp plasma glucose,energy level, stamina, physical strength , stress level, symptoms of Diabetes, micro-albuminuria, dose of OHAs, Physicianâ??s Global evaluation for overall change on CGI-I Scale,clinically significant abnormal laboratory parameters, Global assessment of overall safety of Dabur Ratnaprash Sugar free as per the physician & Subject Timepoint: 90 Days (3 Months) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India Limited
Outcome results
None listed