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CTRI Number  CTRI/2025/03/082439 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Nagaradi Lepa Bandage in Ankle Sprain 
Scientific Title of Study
Modification(s)  		 Randomised Comparative Clinical Evaluation Of A Developed Nagaradi Choorna Patch And Herbal Patch In Pain Management Of Ankle Sprain 
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 Sweta Mer 
Designation  PG SCHOLAR 
Affiliation  PARUL INSTITUTE OF AYURVED 
Address  parul institute of ayurved department of shalya tantra 4th floor room no 403 parul university limda vadodara gujarat.

Vadodara
GUJARAT
391760
India 
Phone  06352267573  
Fax    
Email  swetamer17@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Hemant Toshikhane 
Designation  Dean & Principal Parul Institute of Ayurved, Vadodara 
Affiliation  PARUL INSTITUTE OF AYURVED 
Address  parul institute of ayurved department of shalya tantra 4th floor room no 403 parul university limda vadodara gujarat.

Vadodara
GUJARAT
391760
India 
Phone  9446023359  
Fax    
Email  hemant.toshikhane@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Aswin Haridas 
Designation  associate professor 
Affiliation  PARUL INSTITUTE OF AYURVED 
Address  parul institute of ayurved department of shalya tantra 4th floor room no 403 parul university limda vadodara gujarat.

Vadodara
GUJARAT
391760
India 
Phone  9446023359  
Fax    
Email  draswinharidas89@gmail.com  
 
Source of Monetary or Material Support  
Will be purchased from vaidyaratnam pharmacy with authentic certificate  
 
Primary Sponsor  
Name  PARUL INSTITUTE OF AYURVED 
Address  parul institute of ayurved department of shalya tantra 4th floor room no 403 parul university limda vadodara gujarat 
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 Sweta Mer  PARUL INSTITUTE OF AYURVED  403 room no, 4th floor Department of Shalya Tantra Parul Institute of Ayurved Limda ,Vadodara, Gujarat
Vadodara
GUJARAT 		 6352267573

swetamer17@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M256||Stiffness of joint, not elsewhereclassified. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Nagradi Choorna Patch, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - Nagaradi choorna patch is applyied over affected ankle joint for 7days
2Comparator ArmDrugOther than Classical(1) Medicine Name: Herbal patch , Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - Herbal patch is applied over affected ankle joint for 7days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Diagnose cases of first and second grade ankle sprain, radiologically absence of fracture or dislocation.
2.Both of the gender in the age group 18 to 50 years
3.Recent onset, less than two weeks.
4. Unilateral Ankle sprain
 
 
ExclusionCriteria 
Details  1.Patients associated with third grade and radiologically fracture or dislocation.
2.Patients below 18years and above 50years of age.
3.Chronicity more than two weeks.
4. Bilateral Ankle sprain
5. Wound site
6. HIV:+ve, HBsAg:+ve, VDRL:+ve,
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain Reduction, Swelling, and Range of Motion Assessed Using the Karlsson Peterson Scoring  From Commencement of Pain, Swelling, and Range of Motion on Day 1, Day 8, and Day 21





 
 
Secondary Outcome  
Outcome  TimePoints 
The duration needed for the patient to achieve full functional recovery & return to daily activities AND Recorded to determine whether patients required supplementary pain relief  From Commencement of Pain, Swelling, & Range of Motion on Day 1, Day 8, & Day 21
 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
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)   15/04/2025 
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
Modification(s)  		 Years="1"
Months="0"
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
Modification(s)  

Ankle sprain is a common musculoskeletal injury caused by activities such as sports, accidental falls, or walking on uneven surfaces, leading to pain, swelling, and restricted movement. Conventional treatments like analgesics, anti-inflammatory drugs, and immobilization mainly provide symptomatic relief but often fail to ensure sustained local action, resulting in delayed recovery and increased healthcare burden.

This study focuses on Nagaradi Choorna–based transdermal patch, inspired by the classical Ayurvedic formulation Nagaradi Lepa, which is known for its anti-inflammatory and analgesic properties. The transdermal patch allows localized, controlled, and sustained drug delivery directly at the site of injury, improving effectiveness and patient compliance.

Thus, this approach highlights a unique integration of traditional Ayurvedic medicine with modern drug delivery systems, offering a safer and more effective alternative for the management of ankle sprain.

Hence the need and uniqueness of study

 
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