A Clinical trial to study the effect of Vajra Guggulu in the management of Diabetic Neuropathy
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2023/08/056468
- Lead Sponsor
- Principal Parul Institute of Ayurved
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparision of effect of Vajra Guggulu with Pregabalin in patients of Diabetic NeuropathyTimepoint: Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90
- Secondary Outcome Measures
Name Time Method 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