Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: I10- Essential (primary) hypertension
Conditions
Interventions
None listed
Sponsors
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with diabetes mellitus and hypertension, both on conventional treatment (Metformin or Amlodipine) for at least 6 months of duration 2. Willing and able to give informed consent for participation in the trial. 3. Patients who are willing to adhere to conventional care for the duration of the trial 4. Individuals of any gender aged 18 years or above. 5. Patients on medication for Diabetes with good and fair control of Diabetes mellitus (HbA1c 6.5-8) 6. Patients with grade 1 Hypertension, Systolic hypertension 140 -159 mmHg and diastolic hypertension 90- 99 mmHg
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. History of allergy or drug hypersensitivity to any of the Ayurveda interventions 3. Having participated in other clinical trials within 12 weeks before the screening or currently enrolled in another trial. 4. Known kidney disease 5. Patients with blood pressure greater than 159 mmHg Systolic or greater than 99 mmHg diastolic 6. Patients with HbA1c greater than 8.0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Blood pressure, HbA1c, and Lipid Profile from baseline to Month 24Timepoint: Baseline, 8 weeks, 24 weeks,48 weeks, 72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Oxidative stress through d-ROMs (Reactive Oxygen-Free Radical Metabolites) from baseline to Month 18.Timepoint: Baseline, 8 weeks, 24 weeks,48 weeks, 72 weeks | — |
Countries
India
Contacts
Public ContactDr Ranjan Solanki
AIIMS Nagpur
Outcome results
None listed