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CTRI Number  CTRI/2023/08/056468 [Registered on: 14/08/2023] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to study the effect of Vajra Guggulu in the management of Diabetic Neuropathy 
Scientific Title of Study   Open Labelled Active Controlled Randomised Evaluation of Vajra Guggulu in the Management of Diabetic Neuropathy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankit Kumar 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  8527738148  
Fax    
Email  rockingdeshant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailesh V Deshpande 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaishali S Deshpande 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda & Research 
Address  OPD No 08 Department of Kayachikitsa Khemdas Ayurved Hospital Parul University Ishwarpura Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Parul University 
 
Primary Sponsor  
Name  Principal Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankit Kumar  Parul Ayurveda Hospital  OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia 391760 Vadodara Gujarat
Vadodara
GUJARAT 
08527738148

rockingdeshant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vajra Guggulu, Reference: Rasratnakar/ Vaatrakta , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-PregabalinDose: 150 mg BD, Route: Oral, Dosage form: Tablet, Duration: 3 Months
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparision of effect of Vajra Guggulu with Pregabalin in patients of Diabetic Neuropathy  Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Diabetic Neuropathy (DN) is an early and common complication affecting approximately 50% of the Diabetic patients. DN is caused by degeneration of myelinated and non-myelinated nerve fibers. It most commonly presents as diminished perception of sensation of vibration in distal part of limbs in glove and stocking pattern, impairment of perception of sensory stimuli, loss of tendon reflexes, etc. In patients showing symptoms predominant sensory abnormalities include paraesthesia in feet, pain in limbs, burning sensation in palms and soles, cutaneous hyperesthesia, numbness in feet. Muscle weakness and wasting develop in advanced stages of DN. Line of treatment in contemporary system of medicine focuses mainly on strict glycemic control with anti-convulsant (gabapentin, pregabalin) and antidepressants (amitriptyline, imipramine),opiates and in clinical practice analgesics, NSAIDs or corticosteroids are also used to relieve neuropathy pain. Diabetes and its complications are major causes of mortality, morbidity and poor quality of life. Long term use of anti-convulsant and anti-depressants produce many side effects- nausea, increased appetite, weight gain, loss of libido, erectile dysfunction, fatigue, drowsiness, insomnia, dry mouth, constipation, dizziness, agitation, irritability, etc. Anxiety, liver damage, brain damage due to hypoxia resulting from respiratory depression, development of tolerance and dependence on opiates. In Ayurvedic classicals there is no disease which can be correlated with DN, however detailed description of Prameha and its Upadrava available in classical treatises can help in understanding DN from Ayurveda’s perspective. Symptoms mentioned in Purvarupa and Upadrava of Prameha and Madhumeha show close resemblance with signs and symptoms of DN. Recent researches in Ayurveda have proved efficacy of various herbal and Herbomineral drugs in Diabetic Neuropathy. Ayurvedic medicines such as Ashwagandha,  Amalki,  Guduchi,  Shilajatu etc. evaluated through different preclinical or clinical studies. But still effective treatment is not available even on long term use of Ayurvedic or conventional management.

 
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