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Prevention and management of diabetic complications by an Ayurvedic formulation

Prevention and management of type-2 diabetes mellitus and associated vascular complications by a poly herbal formulation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005366
Enrollment
1000
Registered
2015-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type-2 Diabetes mellitus

Interventions

Intervention1: Test formulation 500mg twice per day for a period of 6 months.: In order to propose a novel plant based Ayurvedic formulation the standard extract derived out of four plants dried root

Sponsors

SRM University
Lead Sponsor
Department of Science Technology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of type-2 diabetes mellitus 2. Fasting blood glucose level 3. Postprandial blood glucose level Elevated pro-inflammatory markers like TNF-alpha, IL-6, hs.CRP, Resistin, low concentration of adiponectin

Exclusion criteria

Exclusion criteria: Patients of type-1 diabetes mellitus Age <35 years and >65 years Fasting Blood glucose level >225mg/dl Postprandial blood glucose level >350mg/dl Patients suffering from chronic illness like T.B., Rheumatoid arthritis, diagnosed CHD cases. Pregnant and lactating women Sudden deterioration in patients health during the period of study Non compliance of the patient

Design outcomes

Primary

MeasureTime frame
The test formulation prevents the development of nephropathy, neuropathy and retinopathy among diabetic patients. It has beneficial role in the management of diabetic microvascular complications.Timepoint: Parameters measured at baseline (initial), 3 months, 6 months and 12 months. The blood glucose level was estimated at the end of every month upto 12 months

Secondary

MeasureTime frame
The test formulation prevents the onset of adverse coronary event among diabetic patientsTimepoint: Parameters measured at baseline (initial), 3 months, 6 months and 12 months. The blood glucose level was estimated at the end of every month upto 12 months

Countries

India

Contacts

Public ContactDr R Mohankumar

Interdisciplinary School of Indian System of Medicine

gpdubey13@gmail.com9450963942

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026