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

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,

• Registration Number: CTRI/2023/08/056468
• Lead Sponsor: Principal Parul Institute of Ayurved

Brief Summary

DiabeticNeuropathy (DN) is an early and common complication affecting approximately 50%of the Diabetic patients. DN is caused by degeneration of myelinated andnon-myelinated nerve fibers. It most commonly presents as diminished perceptionof sensation of vibration in distal part of limbs in glove and stockingpattern, impairment of perception of sensory stimuli, loss of tendon reflexes, etc.In patients showing symptoms predominant sensory abnormalities include paraesthesiain feet, pain in limbs, burning sensation in palms and soles, cutaneoushyperesthesia, numbness in feet. Muscle weakness and wasting develop in advancedstages of DN. Line of treatment in contemporary system of medicine focusesmainly on strict glycemic control with anti-convulsant (gabapentin, pregabalin)and antidepressants (amitriptyline, imipramine),opiates and in clinicalpractice analgesics, NSAIDs or corticosteroids are also used to relieveneuropathy pain.Diabetes and its complications are major causes of mortality, morbidity andpoor quality of life. Long term use of anti-convulsant andanti-depressants produce many side effects- nausea, increased appetite, weightgain, loss of libido, erectile dysfunction, fatigue, drowsiness, insomnia, drymouth, constipation, dizziness, agitation, irritability, etc. Anxiety, liverdamage, brain damage due to hypoxia resulting from respiratory depression,development of tolerance and dependence on opiates. In Ayurvedic classicalsthere is no disease which can be correlated with DN, however detaileddescription of Prameha and its Upadrava available in classical treatises canhelp in understanding DN from Ayurveda’s perspective. Symptoms mentioned inPurvarupa and Upadrava of Prameha and Madhumeha show close resemblance withsigns and symptoms of DN. Recent researches in Ayurveda have proved efficacy ofvarious herbal and Herbomineral drugs in Diabetic Neuropathy. Ayurvedicmedicines such as Ashwagandha, Amalki, Guduchi, Shilajatu etc. evaluated through differentpreclinical or clinical studies. But still effective treatment is not availableeven on long term use of Ayurvedic or conventional management.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Last Update Posted: 2024-09-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

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

• Patients suffering from any of the following diseases: 1.Rheumatic disease.
• 2.K/C/O Vitamin deficiency.
• 3.Alcoholism and any other drug abuse.
• 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 Neuropathy	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.	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.	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.	Baseline, Day 90

Trial Locations

Locations (1)

Parul Ayurveda Hospital; 🇮🇳 Vadodara, GUJARAT, India

Parul Ayurveda Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Ankit Kumar

Principal investigator

08527738148

rockingdeshant@gmail.com