A clinical trial to evaluate the effect of Sarivadi Lauha in patients of Diabetic Neuropathy

An Open Labelled Randomised Active Controlled Evaluation of Sarivadi Lauha in the Management of Diabetic Neuropathy - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082532

Enrollment

Registered

2025-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Eligibility

Inclusion criteria

Inclusion criteria: 1 Known case of Diabetes Mellitus with clinical signs and symptoms of Diabetic neuropathy (Tingling/Pricking/Burning/Numbness) 2 Patient with good to moderate glycemic control 3 Known case of Diabetes mellitus with MNSI Questionnaire score of greater than or equal to 7 and MNSI Examination score of greater than or equal to 2.5. 4 Patient showing altered vibration perception on the basis of biothesiometer. 5 Nerve condution velocity showing the altered velocity of selected nerves in diabetes patients.

Exclusion criteria

Exclusion criteria: 1. Known case of vitamin B12 deficiency. 2 Patients who present with alcohol abuse. 3 Known cases of autoimmune diseases; including Sjogrenâ??s syndrome, lupus, rheumatoid arthritis, vasculitis and Para neoplastic disorders, and any other SOL-causing nerve dysfunction. 4 Known cases of infection - Leprosy, HIV, STDs, and hepatitis B and C. 5 Known cases of uncontrolled Hypertension. 6 Known cases of Parkinsonism and any other nerve degenerative disorders.7 Patients with known allergy to any drug ingredients of study medicine in the trial group and control group

Design outcomes

Primary

Measure	Time frame
Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patient of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening InstrumentTimepoint: Baseline, day 15, day 30, day 45, day 60, day 75 and day 90	—

Secondary

Measure	Time frame
Compare the efficacy of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of symptoms observed in patientsTimepoint: Baseline, Day 15, Day 30, day 45, Day 60, Day 75, Day 90;Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of Nerve Conduction Velocity Test( In 7 patient of each group)Timepoint: Baseline, Day 90;Compare the safety of Sarivadi Lauha and Pregabalin+ Methylcobalmine on the basis of adverse events and biochemical parameters â??haemogram, renal and hepatic function test, urine routine and microscopic and glycosylated hemoglobin.Timepoint: Adverse events on Day 15, Day 30, Day 45, Day 60, Day 75 and Day 90 Biochemical parameters on Baseline, Day 90	—

Measure

Time frame

Compare the efficacy of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of symptoms observed in patientsTimepoint: Baseline, Day 15, Day 30, day 45, Day 60, Day 75, Day 90;Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of Nerve Conduction Velocity Test( In 7 patient of each group)Timepoint: Baseline, Day 90;Compare the safety of Sarivadi Lauha and Pregabalin+ Methylcobalmine on the basis of adverse events and biochemical parameters â??haemogram, renal and hepatic function test, urine routine and microscopic and glycosylated hemoglobin.Timepoint: Adverse events on Day 15, Day 30, Day 45, Day 60, Day 75 and Day 90 Biochemical parameters on Baseline, Day 90

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Countries

India

Contacts

Public ContactDr Shailesh V Deshpande

Parul Institute of Ayurved

dr.shaileshd@gmail.com9763104451

Outcome results