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CTRI Number  CTRI/2024/04/066544 [Registered on: 30/04/2024] 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 To Study Evaluate The Effect of Meha Mudgar Rasa in Diabetic Neuropathy 
Scientific Title of Study   Open Labelled Active Controlled Randomised Evaluation of Meha Mudgara Rasa 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 Meha Gandhi 
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  9824566322  
Fax    
Email  gandhimeha007@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 Ayurveda 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, AP-Limda, TAL- Waghodia, Vadodara ,Gujarat, India - 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat 391760 
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 Meha Gandhi  Parul Ayurved Hospital  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia 391760
Vadodara
GUJARAT 		 9824566322

gandhimeha007@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
1Comparator Arm (Non Ayurveda)-Tab. PregabalinDose:150 mg BD Dosage Form :Tablet Route : Oral Duration :3 Months
2Intervention ArmDrugClassical(1) Medicine Name: Meha Mudgara Rasa, Reference: Bhaisjya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.  
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of effect of Meha Mudgara Rasa with Pregabalin in patients of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening Instrument.  Baseline, Day 15, Day 30, day 45, Day 60, Day 75, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the efficacy of Meha Mudgara Rasa with Pregabalin in patients of Diabetic neuropathy on the basis of symptoms observed in patients  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.  Baseline, Day 90 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   13/05/2024 
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.1 At present India have 35 million diabetics (5.5% of population), which is likely to reach 80 million by 2030. Prevalence of peripheral diabetic neuropathy is high (40.3%). Patients with type 2 diabetes (42.2%) are more often affected than those with type 1 diabetes (29.1%).2 Diabetic neuropathy is a nerve damaging disorder associated with diabetes mellitus, which causes micro-vascular complications involving small blood vessels that supplies to nerves, i.e. vasa nervorum are responsible for diabetic neuropathy. Diabetic peripheral neuropathy is a common condition, often unreported (asymptomatic / painless neuropathy) and inadequately treated resulting in a great deal of morbidity. Type A and Type C fibre generated distal peripheral neuropathy is the most common type of diabetic neuropathy. Peripheral diabetic neuropathy is pathologically characterized by distal motor axonal loss, decrease in the nerve conduction and sensory axonal loss leading to degeneration of small myelinated, large myelinated and demyelinated sensory nerve fibres. It affects the feet and legs first, followed by the hands and arms. Signs and symptoms of peripheral neuropathy are often worse at night and may include. 1. Numbness or reduced ability to feel pain or temperature changes. 2. Tingling or burning sensation. 3. Sharp pains or cramps. 4. Increased sensitivity to touch - for some people, even the weight of a bedsheet can be painful. 5. Muscle weakness. 6. Loss of reflexes, especially in the ankle. 7. Loss of balance and coordination. 3 In Ayurvedic classicals there is no disease which can be correlated with DN, however detailed description of Prameha and its Upadarava 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 the signs and symptoms of DN. The symptoms of Upadrava (complication) of Prameha are Daha (burning sensation), Suptata (numbness), Harsha (tingling sensation), Shosha (wasting), Dourbalya (weakness), Angasada. 4 Line of treatment in contemporary system of medicine focuses mainly on strict glycemic control along with anti-convulsant (gabapentin, pregabalin) and antidepressants (amitriptyline, imipramine), opiates3 and in clinical practice analgesics, NSAIDs or corticosteroids are also used to relieve neuropathy pain .But still effective treatment is not available even on long term use of Ayurvedic or conventional management. 
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