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CTRI Number  CTRI/2023/05/052162 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial Of Ayurved Intervention And Contemporary Protocol In Snayugata Aghataja Shoth With Special Reference To Ankle Sprain 
Scientific Title of Study   A Randomized Controlled Trial Of Ayurved Intervention And Contemporary Protocol In Snayugata Aghataja Shoth With Special Reference To Ankle Sprain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swapnil Khandagale 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9970228982  
Fax    
Email  swapnilkhandagale71@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narinder Singh 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9549370912  
Fax    
Email  narinder.1973@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapnil Khandagale 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Shalya Tantra National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur Rajasthan – 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9970228982  
Fax    
Email  swapnilkhandagale71@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Deemed To Be University (De-Novo) Jorawar Singh Gate Amer Road Jaipur Rajasthan – 302002 
Type of Sponsor  Research institution and hospital 
 
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 Swapnil Khandagale  NIA HOSPITAL  OPD NUMBER - 28 National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002
Jaipur
RAJASTHAN 		 9970228982

swapnilkhandagale71@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:S934||Sprain of ankle. Ayurveda Condition: LD-6-स्नायुमर्मविद्ध,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-PRICE protocolInflammatory Phase (0-5 days) 1.PRICE - Protocol: Protection, Rest, Ice Compression and Elevation. 2.Ankle Immobilization 3.Anti-inflammatory (Serratiopeptidase with Diclofenac Potassium) twice daily with water. Proliferative Phase (6-10 days) 1. Patient education regarding gradual increase in activity level, guided by symptoms. 2. Practise Foot and Ankle Functions focussing Range of Motion Active Stability Motor Coordination 3. Ankle brace 4.Anti-inflammatory (Serratiopeptidase wi
2Intervention ArmDrugClassical(1) Medicine Name: Gandha Taila, Reference: Sushrutha samhita Bhagna Chikitsa 3/ 55-66, Route: Oral, Dosage Form: Taila, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Punarnavaadi Guggulu, Reference: Bhaishaja Ratnavali Vatarakta Rogadhikar -109- 113, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -
4Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sushrutha samhita Bhagna Chikitsa 3/ 55-66, Procedure details: Luke warm gandha taila will be appiled to all over injuried ankle followed by bandaging of injuried ankle)
(1) Medicine Name: Nishadhi Lepa, Reference: Sharangdhar Uttar Khand Lepa Aadhya 11 /83, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 10 Days
(2) Medicine Name: Gandha Taila, Reference: Sushrutha samhita Bhagna Chikitsa 3/ 55-66, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Duration: 10 Days
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Patients with typical history & clinical features pertaining to Acute ankle sprain of grades I & II presented with in initial 72 hours of injury.
2.Grade I : No laxity, minimal pain and mild swelling .
3.Grade II : Mild to moderate laxity, soft tissue swelling, anterior drawer and talar tilt is slightly positive. 
 
ExclusionCriteria 
Details  1.Ankle Impingement
2.Tarsal Tunnel Syndrome
3.Sinus Tarsi Syndrome
4.Cartilage or osteochondral injuries
5.Peroneal Tendinopathy or subluxation
6.Posterior Tibial Tendon Dysfunction
7.Systemic disease - CVS , CKD
8.Wound over ankle
9.Ankle dislocation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall improvement in the symptoms of ankle sprain using the ayurved intervention  Day of presentation ,5TH day ,11th day ,21st day  
 
Secondary Outcome  
Outcome  TimePoints 
To test the efficacy of the protocol developed for Ankle Sprain in terms of improvement as per Ayurvediya Preview in comparison to standard treatment protocol  3 weeks  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) 15/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/09/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Clinical review to develop Protocol for Ankle Sprain in Ayurveda Sunil Kumar1 , Swapnil Khandagale2 , Sarvesh Kumar Agrawal3 , Narinder Singh4 1Post Graduate Scholar, Department of Swasthavritta, National Institute of Ayurveda, Jaipur, Rajasthan, India. 2Post Graduate scholar, Department of Shalya Tantra, National Institute of Ayurveda, Jaipur, Rajasthan, India. 3Associate Professor, Department of Swasthavritta, National Institute of Ayurveda, Jaipur, Rajasthan, India. 4Associate Professor, Department of Shalya Tantra, National Institute of Ayurveda, Jaipur, Rajasthan, India 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will
be selected. All the participants who voluntarily agree to participate and provide informed written
consent for participation will be recruited in the study.
Total 30 participants will be selected after details examination and divided in 2 group of 15 patients
each as per study protocol. All Procedures will be executed done under aseptic condition . Patient will be taken for follow-up
initially 5 th day ,11 th day , 21 st day ,follow up for next 3 weeks ( weekly interval ).
 
 
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