A Clinical trial to study the effect of Vajra Guggulu in the management of Diabetic Neuropathy

Open Labelled Active Controlled Randomised Evaluation of Vajra Guggulu in the Management of Diabetic Neuropathy - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056468

Enrollment

Registered

2023-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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.Age- 40-70 years (both years inclusive). 2.Gender- Both male and female. 3.Known cases of Diabetes mellitus with symptoms of Diabetic Neuropathy. 4.Patients with good to moderate glycemic control. 5.Patients with MNSI Questionnaire score of =7 and MNSI Examination Score of =2.5. 6.Patients showing altered Vibratory perception of sensory stimulus on the basis of Bio-thesiometer.

Exclusion criteria

Exclusion criteria: Patients suffering from any of the following diseases: 1.Rheumatic disease. 2.K/C/O Vitamin deficiency. 3.Alcoholism and any other drug abuse. 4.K/C/O Paraneoplastic disorder and any other SOL causing nerve dysfunction. 5.K/C/O Cerebral vascular disease. 6.K/C/O Parkinsonism and any other nerve degenerative disorders. 7.K/C/O Leprosy, HIV-AIDS, STDs, and other immune-compromised conditions. 8.Patients with acute complications of Diabetes mellitus. 9.K/C/O uncontrolled Hypertension. 10.Patients with known allergy to any drug ingredients of study medicine in trial group and control group.

Design outcomes

Primary

Measure	Time frame
Comparision of effect of Vajra Guggulu with Pregabalin in patients of Diabetic NeuropathyTimepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90	—

Secondary

Measure	Time frame
Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of Biothesiometer & Michigan Neuropathy Screening Instrument.Timepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90;Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of symptoms observed in patients.Timepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90;Compare the safety of Vajra Guggulu & Pregabalin on the basis of adverse events & biochemical parameters – hemogram, renal & hepatic function test, urine routine & microscopic & glycosylated haemoglobin.Timepoint: Baseline, Day 90	—

Measure

Time frame

Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of Biothesiometer & Michigan Neuropathy Screening Instrument.Timepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90;Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of symptoms observed in patients.Timepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90;Compare the safety of Vajra Guggulu & Pregabalin on the basis of adverse events & biochemical parameters – hemogram, renal & hepatic function test, urine routine & microscopic & glycosylated haemoglobin.Timepoint: Baseline, Day 90

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Countries

India

Contacts

Public ContactDr Vaishali S Deshpande

Parul Institute of Ayurveda

dr.shaileshd@gmail.com9763104451

Outcome results