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CTRI Number  CTRI/2024/10/075318 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Agnikarma with Suvarnashalaka in the management of Gradhrasi (Sciatica) 
Scientific Title of Study   RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF AGNIKARMA WITH SUVARNSHALAKA IN THE MANAGEMENT OF GRIDHRASI WITH SPECIAL REFERENCE TO SCIATICA. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShubham Vilas Patil 
Designation  MS Scholar -Shalya Tantra 
Affiliation  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya 
Address  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india

Aurangabad
MAHARASHTRA
431002
India 
Phone  7770055886  
Fax    
Email  shubhampatil2554@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSwapnil More 
Designation  Asso. Professor and Pg Guide 
Affiliation  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya 
Address  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india

Aurangabad
MAHARASHTRA
431002
India 
Phone  8983357106  
Fax    
Email  dr.swapnilmore23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSwapnil More 
Designation  Asso. Professor and Pg Guide 
Affiliation  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya 
Address  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india

Aurangabad
MAHARASHTRA
431002
India 
Phone  8983357106  
Fax    
Email  dr.swapnilmore23@gmail.com  
 
Source of Monetary or Material Support  
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya, Kanchanwadi, Chatrapati Sambhajinagar,431001  
 
Primary Sponsor  
Name  DrShubham Patil 
Address  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya, Paithan Road, Kanchanwadi,Aurangabad MAHARASHTRA 431002 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 
DrShubham Patil  Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi   Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya,opd no 16 Paithan Road, Kanchanwadi
Aurangabad
MAHARASHTRA 
7770055886

shubhampatil2554@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chhatrapati shahu maharaj shikshan sanstha institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Charak.Che 28/100, Procedure details: Latral position will be given. Agnikarma will be done by Suvarna Shalaka at the site of maximum Sparshasathva on 1st, 7th day. After Agnikarma immediately Ghrut will be applied as a cooling agent.)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient having age group of 30-70 yrs.
Irrespective of any gender, any socioeconomic site occupation.
Patient with sign and symptoms sciatica.
 
 
ExclusionCriteria 
Details  Patient associated with known H/O any spinal surgery.
Malignancy, Lumbar Spine injury.
Osteoarthritis, Osteoporosis, Scoliosis.
Patient not eligible for Agni karma as per Ayurveda
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
pain relief,increase leg range of movement  1st,7th,14th dayu
 
 
Secondary Outcome  
Outcome  TimePoints 
easy to walk  14th day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   18/10/2024 
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="1"
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  
 The prevalence of Gridhrasi is 1.2%, Untreated Gridhrasi can cause problems such as: erectile dysfunction (ED), menstrual problems, constipation, incontinence, urinary problems, leg swelling or edema, reproductive issues, and other problems. Gridhrasi is the commonest disease we observed as per the previous research there are various drugs that have been explored scientifically on Gridhrasi while reviewing the literature it was observed Agni karm with suvarnashalaka was not much studied till date hence hoping this studing may contribute further to public health. we have decided to use Agni karma with suvarnashalaka in the management of Gridhrasia
The effect of the Kati Basti on different parameters gridhrasi. After a course of the Kati Basti, the analysis of the patients revealed that there is a statistically significant improvement seen in the parameters like sthambha, Ruk, toda, magnitude of pain, neurological deficit, functional ability, and functional disability.
 Agnikarma are simple, cheap, safe, and effective in the management of Gridhrasi but Agnikarma is more effective than Siravedha in relieving the main symptoms of the disease.
Pain is chief cause of visiting a doctor in most patient. it is known asruja which is one of the symptoms of gradhrasi. It disturb physical and mental status of patient.
 
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