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CTRI Number  CTRI/2024/04/066484 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Modified method of agnikarma in patient of Frozen shoulder 
Scientific Title of Study   A Clinical study of experienced based modified method of agnikarma in the management of avabahuka with special reference to frozen shoulder 
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 Dhruvi Kanani 
Designation  PG Scholar  
Affiliation  J S Ayurveda mahavidyalaya 
Address  Department of Panchkarma J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital college road kheda nadiad

Kheda
GUJARAT
387001
India 
Phone  8849612993  
Fax    
Email  kananidhruvi80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Jaimin Patel 
Designation  MD Panchkarma 
Affiliation  J S Ayurveda mahavidyalaya 
Address  Department of Panchkarma J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital College road kheda nadiad

Kheda
GUJARAT
387001
India 
Phone  9427859535  
Fax    
Email  vd.jaimin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Jaimin Patel 
Designation  MD Panchkarma 
Affiliation  J S Ayurveda mahavidyalaya 
Address  Department of Panchkarma J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital College road kheda nadiad

Kheda
GUJARAT
387001
India 
Phone  9427859535  
Fax    
Email  vd.jaimin@gmail.com  
 
Source of Monetary or Material Support  
Sundar ayurveda pharmacy nadiad 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  J S Ayurveda Mahavidyalaya college road nadiad 387001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
J S Ayurveda mahavidyalaya  J S Ayurveda mahavidyalaya college road nadiad 387001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhruvi Kanani  J S Ayurveda Mahavidyalaya  Department of Panchkarma J S Ayurveda Mahavidyalaya P D Patel Ayurveda Hospital Kheda Nadiad
Kheda
GUJARAT 		 8849612993

kananidhruvi80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MAM University Nadiad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Nil, Procedure details: Instead of hot Shalaka, flaming cotton swab hold by artery forceps and Arkapatra are used for Agnikarma in this method. The point for Agnikarma is decided by finding most tender location on body surface. The point is covered with an Arkapatra. Then a flaming cotton swab soaked in sprit is brought close to the cover point and kept on it till patient feels burning sensation moderately on that point. Agnikarma procedure will be continue daily for 21 days.)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient will be diagnosed with avabahuka with the help of presence of sign and symptoms like painful movement of shoulder shoulder joint, stiffness of shoulder joint, restricted range of motion of affected shoulder joint. 
 
ExclusionCriteria 
Details  a)Participant suffering from severe systemic illnesses like Diabetic polyneuropathy, tuberculosis, HIV, hepatitis B, known cases of malignancy, gastritis.
b)Patients having uncontrolled Diabetes mellitus.
c)Patient have past history of shoulder joint surgery, fracture, malunion, dislocation of shoulder joint, traumatic arthritis.
d)Pregnant lady, lactating mother. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe and find out changes in signs and symptoms of avabahuka after application of modified method of agnikarma.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1]To find out the changes in the sign and symptoms of the Avabahuka (Frozen Shoulder) after
Agnikarma procedure.
2]To evaluate the changes in the Quality of life of the patient. 		 8 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/05/2024 
Date of Study Completion (India) 07/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  

A statistically highly significant response was obtained to provide relief in pain in the patients of Avabahuka after the treatment. At the end of the study, none of the patient remained unchanged.

Present study concludes that Agnikarma treatment is effective in reducing pain as well as other sign and symptoms of frozen shoulder and improve the quality of daily living activities in the patients.

Since the study has shown positive results, it is recommended that the study should be carried out in large number of patients to evaluate and analyse the results. No any unwanted effect noticed during the entire study period.


 
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