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CTRI Number  CTRI/2025/05/087823 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Dhanadanayanadi Kashay in neuropathy. 
Scientific Title of Study   Randomised controlled clinical trial to evaluate efficacy of Dhanadanayanadi Kashay in management of Distal Symmetrical Polyneuropathy in chronic type 2 Diabetes Mellitus in comparison with Pregabalin. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNeha Dipak More  
Designation  PG Scholar 
Affiliation  Dr.G.D.Pol Foundations Y.M.T. Ayurvedic Medical College Sector 4 Kharghar, Navi Mumbai. 
Address  OPD No.8 Kayachikitsa Department,Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7020718428  
Fax    
Email  nehamore01999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAparna Ninad Sathe 
Designation  Associate Professor  
Affiliation  Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai  
Address  OPD No.8 Kayachikitsa Department,Dr.G.D.Pol Foundations Y.M.T Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9819216230  
Fax    
Email  vdaparnasathe@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNeha Dipak More  
Designation  PG Scholar  
Affiliation  Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai  
Address  OPD No.8 Kayachikitsa Department,Dr.G.D.Pol Foundations Ayurvedic Medical College, Sector 4 Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7020718428  
Fax    
Email  nehamore01999@gmail.com  
 
Source of Monetary or Material Support  
G.D.Pol Foundations Y.M.T.Ayurvedic Medical College,Sector-4,Kharghar,Navi Mumbai,410210,Maharashtra,India 
 
Primary Sponsor  
Name  Dr Neha Dipak More 
Address  OPD No 8 G.D.Pol Foundations Y.M.T.Ayurvedic Medical College and Hospital,Sector 4,Kharghar,Navi Mumbai 410210 Maharashtra,India. 
Type of Sponsor  Other [NIL] 
 
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 Neha Dipak More  Y.M.T.Ayurvedic Medical College and Hospital  OPD No.8 Kayachikitsa Department,Dr.G.D.Pol Foundations Y.M.T Ayurvedic Medical College Sector 4 Kharghar,Navi Mumbai 410210,Maharashtra,India.
Raigarh
MAHARASHTRA 		 7020718428
-
nehamore01999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G628||Other specified polyneuropathies. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dhanadanayanadi Kashay , Reference: Sahastrayoga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: -
2Comparator Arm (Non Ayurveda)-Pregabalin75mg,once a day at 7:00PM
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group within 40-70years.
2.Patients irrespective of gender will be included and who are willing to take medicine.
3.Patients haning TCNS score more than or equal to 6 and less than or equal to 11.
4.Patients having HBA1C upto 10%.
5.Type 2 DM patients presenting with any of the signs like pain,numbness, tingling sensation,burning sensation. 
 
ExclusionCriteria 
Details  1)Patients having type1 DM.
2)Causes of neuropathy other than diabetes mellitus like alcoholic neuropathy, neuropathy due to vit.B12 difficiency,due to thyroidism etc.
3)Patients with K/C/0 – Tuberculosis,AIDS ,Mlignancies,Leprosy
4)Pregnant and lactating women.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Dhanadanayanadi Kashay in comparison with Pregabalin in Distal Symmetrical
Polyneuropathy. 		 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess efficacy of Dhanadanayanadi Kashay in management of distal symmetrical polyneuropathy in the parameters of Toronto Clinical Neuropathy Score  3 months 
To study probable mode of action of drug of study.  3 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/06/2025 
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)   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   The current study aimed as randomised control parallel group trial comparing the efficacy of Dhanadanayanadi Kashay and Pregabalin in the management of Distal Symmetrical Polyneuropathy.Total 52 diagnosed patients of Distal Symmetrical Polyneuropathy are equally
divided into two groups,namely experimental and control group.The symptoms of Distal Symmetrical Polyneuropathy are numbness, tingling,burning sensations and pain in stocking -glove distribution affecting feets and hands.Dhanadanayanadi Kashay 96ml used as experimental group medicine for
single use in the morning empty stomach will be given for 3 months.Pregabalin used as control group medicine for single use at 7:00Pm will be given for 3 months. The study will be
conducted for 3 months.
clinical assessment after every month.
Diabetic neuropathy is a common complication of Diabetes Mellitus. Most common among diabetic neuropathies is Distal Symmetrical Polyneuropathy, accounting for about 75%.
Distal Symmetrical Polyneuropathy (DSPN) is a common form of peripheral neuropathy that primarily affects the distal portions of the extremities in a symmetrical pattern. In Ayurveda, diabetes mellitus is associated with "Prameha," which, when left untreated, 
progresses to "Madhumeha," a chronic and incurable condition. The complications of diabetic 
neuropathy are attributed to "Vataprakopa," presenting symptoms such as Toda, Vyatha, Shul, Supti, Shosha , which closely align with DSPN.In modern medicine line of treatment for neuropathy involves use of tricyclic antidepressants ,anti convulsants like pregabalin ,gabapentin,duloxetine which causes various side effects like dizziness,drowsiness,lack of coordination,blurred
vision,constipation,weight gain etc. again affecting quality of life.
Dhanadanayanadi Kashay is one of the Ayurvedic formulations mentioned in Sahastrayoga,which mainly have katu ,tikta rasatmak,katu vipaka and ushna viryatmak dravyas showing kapha-vaat shaman properties and by ushna virya mainly vaat shamak ,which can be used in diabetic neuropathy.It is easily available and cost effective in nature hence selected for the present study.

 
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