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A Study to find the Effectiveness of Siddha treatment for Vathakarsanam (Diabetic Peripheral Neuropathy)

A Pilot clinical study to explore the effectiveness of selected siddha drugs for Vathakarsanam(Diabetic Peripheral Neuropathy) through MNSI (score and questionnaire ) at Ayothidoss Pandithar Hospital , NIS - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069492
Enrollment
30
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Intervention1: Internal medicine-Madhumegam Chooranam Aavarai kudineer Brahmi Nei and External medicine Adathodai nei: Internal medicine 3 Madhumegam Chooranam Capsules(IMPCOPS) Dosage 2 tid(before fo

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: NIDDN(Non Insulin Dependent Diabetic Medication) Glycated Hemoglobin 7% TO 10% Michigan Neuropathy Screening Instrument (MNSI)-Examination Score 2.5/5 and MNSI Questionnaire Score 7/15 Consider Positive for the presence of Neuropathy Known Diabetes Participants Already on OHAs With or without medication for more than 5 years with Numbness,Burning sensation of foot and Pricking Pain in both Leg and Foot and toes.

Exclusion criteria

Exclusion criteria: IDDM(Insulin Dependent Diabetes Mellitus) Secondary Uncontrolled Hypertension (150 TO 90 MM HG) Vitamin B12 Deficiency CVA,Old CVA,Seizure disorder Gestational Diabetes Mellitus CKA and AKD Participants Varicose Veins, Non Healing Ulcers,Amputation/Surgery in Lower Limb Participans with lumbosacral radiculopathy testing Positive for Straight Leg Raising and Las Segue Sign

Design outcomes

Primary

MeasureTime frame
Proportion of participants achieving a score of MNSi 2.5/5 and Questionnaire 7/15 as asseessed at baseline and end pointTimepoint: Baseline 0th day 30th day 60th day 90th day End point 120th day Base line 0 day 30th day 60th day 90th day End point 120th day

Secondary

MeasureTime frame
Comparing the Bipthesiometry score from baseline to end point in patients who attained Minimal Clinically Important Difference(MCID) Difference in FBS,PPBS,HbA1c from baseline to endpoint Difference in HOMA-IR from baseline to end point Improvement in quality of life from baseline to end pointTimepoint: Baseline -0 day 30th day 60th day 90th day 120th day

Countries

India

Contacts

Public ContactProf Dr G J Christian

National Institute of Siddha

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026