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CTRI Number  CTRI/2023/09/058073 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Ashwagandha Churna In Diabetic Neuropathy 
Scientific Title of Study   A Controlled Clinical Study To Evaluate The Effect Of Ashwagandha Churna In The Management Of Madhumeha w.s.r. To 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 Ayush Dhankhar 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  7665144279  
Fax    
Email  dr.ayushdhankhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukumar Nandigoudar 
Designation  Professor 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9986125625  
Fax    
Email  vaidyasukumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ayush Dhankhar 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  7665144279  
Fax    
Email  dr.ayushdhankhar@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College And Post Graduation Centre  
 
Primary Sponsor  
Name  Dr Ayush Dhankhar 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka 
Type of Sponsor  Other [SELF] 
 
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 Ayush Dhankhar  Padma Ayurvedic Hospital And Research Centre  OPD Department Of Kayachikitsa Ground floor Padma Ayurvedic Hospital And Research Centre Terdal 587315
Bagalkot
KARNATAKA 		 7665144279

dr.ayushdhankhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  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: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Dashamoola, Reference: Charaka Samhita Sutra Sthana 4/15, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha Choorna, Reference: Bhavprakasha Nigantu, Guduchyadi Varga, Purva Khanda,189-190, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukhosna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients having cardinal symptoms of Madhumeha Upadrava like Daha, Harsha, Suptata and Shula will be selected.
2.Diagnosed case of Type 2 Diabetic Neuropathy will be included.
3.Mild to moderate Neuropathy patients having Toronto score between 6 to 11 will be included.
4.Both fresh and treated cases will be included in the study.
5.On-going oral hypoglycaemic agents will be continued during study.
6.No other neuropathy managing drugs are allowed during study period.
7.Patient who are willing to sign written consent will be included. 
 
ExclusionCriteria 
Details  1.IDDM (Type 1 DM) will be excluded from study.
2.Diabetic patients with chronic alcoholism will be excluded.
3.Pregnant and lactating women will be excluded.
4.Patient with any other serious condition which have negative impact on the nerves like Meningitis/encephalitis/Polio etc. will be excluded.
5.Patient having any other associated clinical condition like Dementia, Parkinson, Stroke which influence peripheral nerve function will be excluded.
6.Patient having ulceration/infection of feet.
7.Medical/Surgical condition limiting functional mobility.
8.Non ambulatory patients.
9.Patients who are not willing to participate / consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of trial drug in classical symptoms of Diabetic Neuropathy and neuro-regeneration assessed by Toronto clinical neuropathy score and Vibration perception Threshold(VPT)
 		 15day,30day, 60day 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of Trial drug & Adverse drug Reaction & Aggravation of the Symptoms of Diabetic Neuropathy   15day,30day,60day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/10/2023 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 Neuropathy (DN) is serious diabetic complication and may affect about 50% to 90% of diabetic patients, out of these, 15% to 30% suffers from painful Diabetic Neuropathy. In Ayurveda, Madhumeha Vyadhi is nearly similar with Diabetes mellitus. The Upadravas of Madhumeha like Daha, Harsha, Suptata, Shoola, are similar with the symptoms of Diabetic Neuropathy. Pathological features of Diabetic Neuropathy can occur in peripheral nerves that includes axonal degeneration of both myelinated and unmyelinated fibres. In myeline sheath discontinuity, Ashwagandha helps to repair myelin sheath as per prior research works. Classical texts of Ayurveda have mentioned Shodhana and Shamana for the management of Prameha hence, here is an effort made to find a simple remedy which is cost effective.
  • Ashwagandha have the properties like neuroprotective, synaptic & neurotic regenerative, myelin sheath repair, analgesic and anti-inflammatory, so it will be helpfull in reducing the symptoms of the DN.
  • Objectives of the study are to evaluate the effect of Ashwagandha Choorna and Dashmoola Kwatha individually and compare the effects of both in the management of Madhumeha w.s.r. to Diabetic Neuropathy.
  • It is a Randomised Controlled Clinical Trial. 40 patients of Diabetic Neuropathy will be selected incidentally and randomly assigned into two groups; Group ‘A’ and ‘B’ by software generated chart.
  • Group A and group B patients will be given Ashwagandha Churna and Dashmoola Kwatha repectively.
  • Subjects will be assessed on the basis of TCNS (Toronto Clinical Neuropathy Score) Score and VPT Value (Vibration perception threshold).
  • Total Study duration will be 60 days and contain 4 visits (0th day, 15th day,30th day, 60th day.), which includes administration of trial drug for 30 days and post medication follow up on 60th day. After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. 
  • On that basis of results, conclusion will be drawn. 
 
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