Health Condition 1: null- Subjects newly diagnosed with mild to moderate Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Aloe vera: Two capsules twice daily 30 minutes prior to break fast and Dinner (1.5g/day)
Intervention2: Aloe vera: Dose and frequency-Two capsules twice daily 30 minutes prior to break
Sponsors
Department of Biotechnology
Vellore Institute of Technology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects in the age group of 35-65 years 2.Subjects newly diagnosed with mild to moderate Type 2 diabetes 3.Subjects having fasting plasma glucose level > 126 mg/dl 4.Subjects having HbA1c level range > 6.5% 5.Subject with a body mass index (BMI)>= 25 kg/m2 and 6.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 7.Subjects, willing to provide informed consent 8.Subjects, willing to comply with the study procedures
Exclusion criteria
Exclusion criteria: 1.Subjects with Type 1 diabetes 2.Subjects with any acute or chronic diabetes- associated complications 3.Subjects with severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarction. 4.Subjects with uncontrolled hypertension 5.Subjects with history of chronic or acute pancreatic disease 6.Subjects with hypersensitivity to investigational product or its additives 7.Women who are lactating, pregnant or to become pregnant during the study 8.Subject using any herbal drugs and dietary supplements for Type 2 diabetes. 9.Subjects with hepatic failure or with renal failure 10.History of drugs or alcohol abuse 11.Subjects with history of chronic infections 12.History of surgical procedures undergone in past six months 13.Participation in a study of another investigational drug within 1 month prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to day 90Timepoint: Change in HbA1c from baseline to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in fasting plasma glucose from baseline at Day 15, Day 30, Day 60 and Day 90 â?¢Change in insulin level from baseline to Day 90 â?¢Subjects with reduction in HbA1c â?¥ 0.5% from baseline to Day 90 â?¢Change in lipid profile from baseline to day 60 and day 90 â?¢Adverse event profile, frequency and severity Timepoint: Day 15, Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactSanjib Kumar Panda
Laila Pharmaceuticals Pvt Ltd
Outcome results
None listed