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CTRI Number  CTRI/2026/03/105918 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effect of Bhunimbadi Churna taken by mouth and Panchatikta Kashaya Parishek with Pregabalin in patients suffering from diabetic nerve damage 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF BHUNIMBADI CHURNA ORALLY WITH PANCHATIKTA KASHAYA PARISHEK AND PREGABALIN IN DIABETIC SENSORY POLYNEUROPATHY 
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 Gaurav Pradeep Bundela 
Designation  PG Scholar 
Affiliation  Seth Govindji Raoji Ayurveda Mahavidylaya Solapur 
Address  Opd no 2,3,10 Kayachikista Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9850750929  
Fax    
Email  gaurav.bundela@pg.sgrayurved.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh I Swami  
Designation  Associate Professor Kayachikitsa Department  
Affiliation  Seth Govindji Raoji Ayurveda Mahavidylaya Solapur 
Address  kayachikitsa department opd no 2 3 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya,118/119 shukrawar peth near juni faujdar chawdi Solapur

Solapur
MAHARASHTRA
413002
India 
Phone  8805774804  
Fax    
Email  santosh.swami@sgrayurved.edu.in   
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Pradeep Bundela 
Designation  PG Scholar 
Affiliation  Seth Govindji Raoji Ayurveda Mahavidylaya Solapur 
Address  Opd no 2,3,10 Kayachikista Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur

Solapur
MAHARASHTRA
413002
India 
Phone  9850750929  
Fax    
Email  gaurav.bundela@pg.sgrayurved.edu.in  
 
Source of Monetary or Material Support  
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India  
 
Primary Sponsor  
Name  Dr Gaurav Pradeep Bundela 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Gaurav Pradeep Bundela  Seth Sakharam Nemchand Jain Ayurveda Rugnalya   Kayachikista OPD 3 2 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India Solapur MAHARASHTRA
Solapur
MAHARASHTRA 		 9850750929

gaurav.bundela@pg.sgrayurved.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Govindji Raoji Ayurveda Mahavidyalya Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E134||Other specified diabetes mellituswith neurological complications. Ayurveda Condition: MADHURARASATIYOGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-PregabalinPregabalin 75mg bid after food orally for 45 days
2Intervention ArmDrugClassical(1) Medicine Name: Bhunimbadi churna, Reference: Ashtang hruday, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: madhu and ghrit), Additional Information:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Presence of one or more of the symptoms i.e allodynia, burning sensation, aching pain, pricking pain ect along with mild to severe impairment according to NTSS-6 score.
2) Patients of both sex of age between 30 to 70 years 
 
ExclusionCriteria 
Details  1) Patients having any other associated clinical conditions influencing peripheral nerve function like peripheral vascular, anemia disorders will be excluded.
2) Patients having any of neuropathic complication i.e. Diabetic foot will be excluded.
3) Patients having chronic alcoholism will be excluded.
4) Patients contraindicated for the pregabalin.
5) Mrudu koshta person will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To access the effect of Bhunimadi churna with Panchatikta Kashaya Parishek and Pregabalin separately on different clinical parameter
To access the effect of drugs and Kashaya Parishek by using the NTSS-6 score 		 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Study the pathogenesis of diabetic sensory polyneuropathy in both Ayurvedic and modern view
To study the co-incidental finding during study 		 45 days 
 
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   N/A 
Date of First Enrollment (India)   23/03/2026 
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="5"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 sensory polyneuropathy is a common and progressive complication of diabetes mellitus characterized by numbness burning sensation tingling pain and sensory loss predominantly in the lower limbs. It significantly reduces quality of life and may lead to serious complications. Current management mainly includes glycemic control and symptomatic treatment such as Pregabalin however long term relief and disease modification remain challenging.

In Ayurveda diabetic sensory polyneuropathy can be correlated with Madhumehajanya upadrava and Vata Pitta involvement. Bhunimbadi Churna mentioned in Ashtanga Hridaya along with Panchatikta Kashaya Parishek is described for conditions involving Kushtha Meha and Suptata and may provide neuroprotective and anti inflammatory effects.

This study is a randomized parallel group controlled clinical trial planned to evaluate the efficacy of Bhunimbadi Churna 1 gram twice daily with Madhu and Ghrita for 45 days along with Panchatikta Kashaya Parishek for 21 days in comparison to Pregabalin 75 mg twice daily for 45 days in patients aged 30 to 70 years suffering from diabetic sensory polyneuropathy.

A total of 60 participants will be randomly allocated into two groups with 30 participants in each group. Assessment will be done using Neuropathy Total Symptom Score 6 Toronto Clinical Neuropathy Score and required nerve conduction studies. Follow up assessments will be carried out on day 15 day 30 and day 45 with final assessment on day 50.

The primary objective is to evaluate and compare the efficacy of Ayurvedic intervention with standard modern treatment in reducing neuropathic symptoms. The results of this study may help in developing an evidence based Ayurvedic treatment protocol for diabetic sensory polyneuropathy.

 
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