Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Chyawanprash 1: 1 teaspoonful in a day for 2 days
Intervention2: Chyawanprash 2: 1 teaspoonful in a day for 2 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Patanjali Ayurved Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age 35 to 65 yrs 2 Subjects having Fasting Blood Glucose level from 90-150 mg/dL (both inclusive) 3 Subjects having current Doctorâ??s note for confirmation of Type II Diabetes Mellitus and willing to let a copy of the Doctorâ??s note be maintained with the study data 4 Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within 03 months prior to enrollment 5 Patients who have taken only Metformin 500 mg twice daily, and no other oral hypoglycemic agent, for at least 3 months prior to the screening visit 6 If any patient is on anti-hypertensive therapy, lipid-lowering agents, or thyroid medications, the dosage must be constant for at least 2 months prior to the screening visit 7 Subjects willing to give a written informed consent for their voluntary participation in the study 8 Subjects willing to abide by the study requirements and visit the site as per study schedule
Exclusion criteria
Exclusion criteria: 1 Subjects having Type 1 Diabetes Mellitus 2 Currently taking or is required to take any herbal products and dietary supplements, during the past 3 months 3 Diagnosed with an eating disorder such as bulimia or binge eating 4 Any acute gastrointestinal disease within 2 weeks prior to study entry 5 History of Cancer 6 Clinically significant cardiac disease or endocrine abnormalities other than stable thyroid disorders 7 History of Bariatric surgery 8 Participation in a clinical study within the previous 30 days 9 Any relevant surgical treatment during the previous two months or planned during the study 10 Subjects on any prescription medications that might interfere with the study outcome 11 Known history of positive HIV 12 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of test product will be measured in terms of mean change in blood glucose (from FBG to post-dose blood glucose level)Timepoint: On Day 1 and Day 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the test product in terms of adverse events reported by subjects or assessed by Investigator during studyTimepoint: On Day 01 and Day 02 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed