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A Clinical To Study Evaluate The Effect of Meha Mudgar Rasa in Diabetic Neuropathy

Phase 3
Conditions
Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Registration Number
CTRI/2024/04/066544
Lead Sponsor
Parul Institute of Ayurved
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Age between 40 and 75 years (both years inclusive).

2. Both male and female.

3. Known case of Diabetes mellitus with symptoms of Diabetic Neuropathy.

4. Patients with good to moderate glycemic control.

5. Known case of Diabetes mellitus with MNSI Questionnaire score of more than or equal to 7 and MNSI Examination

Score of =2.5.32

6. Patients showing altered perception of sensory stimulus on the basis of Biothesiometer.

Exclusion Criteria

1. Known case of Rheumatic disease.

2. Known case of Vitamin deficiency.

3. Alcoholism and any other drug abuse.

4. Known case of Paraneoplastic disorder and any other SOL causing nerve dysfunction.

5. Known case of Cerebral vascular disease.

6. Known case of Parkinsonism and any other nerve degenerative disorders.

7. Known case of Leprosy, HIV-AIDS, sexually transmitted disease, and other immune-compromised conditions.

8. Patients with acute complications of Diabetes mellitus.

9. Known case of uncontrolled Hypertension.

10. Patients with known allergy to any drug ingredients of study medicine in trial group and control group

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of effect of Meha Mudgara Rasa with Pregabalin in patients of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening Instrument.Timepoint: Baseline, Day 15, Day 30, day 45, Day 60, Day 75, Day 90
Secondary Outcome Measures
NameTimeMethod
Compare the efficacy of Meha Mudgara Rasa with Pregabalin 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;Compare the safety of Meha Mudgara Rasa and Pregabalin on the basis of adverse events and biochemical parameters –haemogram, renal and hepatic function test, urine routine and microscopic and glycosylated hemoglobin.Timepoint: Baseline, Day 90
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