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CTRI Number  CTRI/2024/03/064758 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the comparative effect of panchmuli kashaya and meshashrungyadi kashaya with agnikarma in the management of grudhrasi. 
Scientific Title of Study   A randomized parallel arm comparative clinical study to evaluate the efficacy of panchmuli kashaya and meshshrungyadi kashaya in combination with agnikarma in the management of grudhrasi.  
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 Sanjoli Jitendra Waykos 
Designation  PG Scholar 
Affiliation  Seth Govindji Raoji Ayurved Mahavidhyala solapur 
Address  OPD No 2,3,10,Kayachikitsa department,Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur. Solapur MAHARASHTRA 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9421084108  
Fax    
Email  sanjoli.waykos@pg.sgrayurved.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Chandurkar 
Designation  HOD Kaychikitsa Department 
Affiliation  seth govindji raoji ayurved mahavidhyalaya solapur 
Address  OPD No 2,3,10,Kayachikitsa department, Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur. Solapur MAHARASHTRA 413002

Solapur
MAHARASHTRA
413002
India 
Phone  9422788569  
Fax    
Email  vivek.chandurkar@sgrayurved.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sanjoli Jitendra Waykos 
Designation  PG Scholar 
Affiliation  Seth Govindji Raoji Ayurved Mahavidhyala solapur 
Address  OPD No 2,3,10,Kayachikitsa department, Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 Shukrawar peth, Near juni faujdar chawdi, Solapur. Solapur MAHARASHTRA 413002

Solapur
MAHARASHTRA
413002
India 
Phone  9421084108  
Fax    
Email  sanjoli.waykos@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 MAHARASHTRA413002 
 
Primary Sponsor  
Name  Dr Sanjoli Jitendra Waykos 
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  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 Sanjoli Jitendra Waykos  Seth Sakharam Nemchand Jain Ayurvedic Rugnalaya Solapur  OPD NO. 2,3 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA 		 9421084108

sanjoli.waykos@pg.sgrayurved.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Govindji Raoji Ayurved Mahavidhyalaya Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: nerve disorder, (2) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: charak chikitsa28/101, Procedure details: treatment duration 30 days follow up of agnikarma on 0th 10th 20th 30th day.)
(1) Medicine Name: meshashrungyadi kashaya, Reference: vangasen vatvyadhi rogaadhikar 584/585, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 45(ml), Frequency: bd, Duration: 30 Days
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: charak chikitsa 28/101, Procedure details: treatment duration 30 days follow up of agnikarma on 0th 10th 20th 30th day)
(1) Medicine Name: panchmuli kashaya, Reference: chakradatta vaatvyadhi, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 45(ml), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Participant with classical sign & symptoms of Grudhrasi i.e Ruk Toda, Stambha (at affected right or left leg)

2) Participant between age group of 20-60 years irrespective of religion, occupation and socio-economic status will be selected. 
 
ExclusionCriteria 
Details  1) Participant who are suffering from any other known case of systemic diseases i. e. tuberculosis, Cancer, HIV etc.

2) Pregnant and lactating women.

3) Participant taking immunosuppressive medications.

4) Participant with known case of diabetes mellitus will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine effect of Panchmuli Kashaya with Agnikarma in the management of Grudhrasi.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate the safety of Panchmuli Kashaya with Agnikarma & Meshashrunayadi Kashaya with Agnikarma in the management of Grudhrasi.
2)To understand in detail Samprapti of Grudhrasi. 		 30th 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)   31/03/2024 
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="0"
Months="11"
Days="0" 
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   Grudhrasi (sciatica) is a nerve disorder that causes difficulty in walking ,pain and numbness in lower limb so one unable to do his/her daily work easily. It disturb physical and mental status of one who suffer. Keeping in view prevalence of grudhrasi ,limitations in treatment the present study has been designed to compare the efficacy of Panchmuli kashaya and Meshashrungyadi  kashaya with Agnikarma in the management of Grudhrasi The study will be conducted for 30 days. There will be follow up on 10th, 20th and 30th day,  kashaya given after food for 30 days and agnikarma will be done on each follow up.Before and after treatment assessment will be done with the help of SLR Test,Bragards sign and VAS Scale. 
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