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Clinical Study To Evaluate The Effect Of Bhavitha Shilajatu In Diabetic Peripheral Neuropathy

A Comparative Clinical Study To Evaluate The Effect Of Yashtimadhu Bhavita Shilajatu and Balamoola Bhavita Shilajatu In Diabetic Peripheral Neuropathy - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068675
Enrollment
200
Registered
2024-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

None listed

Sponsors

Dr Rakesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Metabolically stable diabetic Subjects with symptomatic Diabetic Peripheral Neuropathy. Subjects fulfilling the diagnostic criteria. Subjects whose HbA1c is between 6.5 to 9%. Subjects of all gender between the age group of 40 - 65 years

Exclusion criteria

Exclusion criteria: Subjects whose HbA1c is more than 9%. Subjects with other metabolic and endocrinal disorders. Subjects with other causes of Polyneuropathy. Subjects suffering from infectious diseases and non healing ulcer/ulcers. Subjects with cardiac aliments and Nephropathy. Subjects with Diabetic Neuropathy in stage N3 of Dyck’s staging

Design outcomes

Primary

MeasureTime frame
Vibration Perception Threshold (VPT) on BIOTHESIOMETER Before and After the TreatmentTimepoint: 1st Assessment – Before Treatment (0th day) 2nd Assessment – During Treatment (31st day) 3rd Assessment – During Treatment (61st day) 4th Assessment – After Treatment (91st day)

Secondary

MeasureTime frame
Diabetic Neuropathy Symptom (DNS) questionnaire Score Before and After the Treatment Diabetic Neuropathy Examination Score (DNE) Before and After the Treatment Visual Analog Scale (VAS) Before and After the Treatment WHO Quality of Life (WHO QoL) BREF Before and After the Treatment Timepoint: 1st Assessment – Before Treatment (0th day) 2nd Assessment – During Treatment (31st day) 3rd Assessment – During Treatment (61st day) 4th Assessment – After Treatment (91st day)

Countries

India

Contacts

Public ContactDr Rakesh

Government Ayurveda Medical College, Mysuru

mythreyrc@gmail.com8618570803

Outcome results

None listed

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