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CTRI Number  CTRI/2025/07/091521 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Other (Specify) [Para surgical Procedure]  
Study Design  Other 
Public Title of Study   Compare of viddhakarma and Agnikarma in the management of Avabahuka  
Scientific Title of Study   Comparative clinical study of viddhakarma and Agnikarma in the management of avabahuka w.s.r. 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 Jay Mangal Yadav 
Designation  MS PG Scholar SHALYA TANTRA 
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  7376410802  
Fax    
Email  iamjaymangal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Arjun  
Designation  Associate Professor Department of Shalya Tantra  
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  6360340886  
Fax    
Email  drarjunanil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof DR Elizabeth P John 
Designation  Professor and HOD Department of Shalya Tantra  
Affiliation  Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshahar Uttar Pradesh 
Address  OPD no. 05 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Khurja Bulandshahar Uttar Pradesh

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9448345918  
Fax    
Email  elizajhn@yahoo.co.in  
 
Source of Monetary or Material Support  
Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalay and PLRD Hospital Khurja Bulandshahar Uttar Pradesh 
 
Primary Sponsor  
Name  Dr Jay Mangal Yadav 
Address  OPD No. 05 department of shalya tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalya Khurja Bulandshahar 203131 Uttar Pradesh 
Type of Sponsor  Private medical college 
 
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 Jay Mangal Yadav  Vaidya Yagya Dutt Sharma Ayuarveda Mahavidyalay Khurja Bulandshahar   OPD no 5 Department of Shalya Tantra Vaidya Ygya Dutt Sharma Ayurveda Mahavidyalya Khurja Bulandshar Uttar Pradesh
Bulandshahar
UTTAR PRADESH 		 7376410802

iamjaymngal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalay Khurja Buulandshar Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M672||Synovial hypertrophy, not elsewhere classified. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patient of either sex above 30 years and below 70 years of age
Pain vedna and stiffness over affected shoulder
Inability to do daily routine work loss of strength dourbalyata.
Paients fit for Viddh Karma
patientas Fit for Agnikarma  
 
ExclusionCriteria 
Details  Patients below 30 years and above 70 years of age
Patients having joints disorders that is RA Osteoarthritis Gouty Arthritis
Patients with HTN and DM
HIV HCV HBsAg positive patients  
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evaluate the effcacy of viddha karma and agnikarma in management of avabahuka Pain reduction and Range of motion improvement   1 month alternate day  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Phase 3 
Date of First Enrollment (India)   08/08/2025 
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   Years="0"
Months="10"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [iamjaymangal@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A vabahuka is one of the Vatavyadhi which hampers the routine activity of the upper arm of an individual and is prevalent in middle and old age population .According to Sushruta  Samhita a condition with symptom of vitiated Vata Dosha in and around shoulder reason causes shosha of Anshbandhana and constraction of blood vessels resulting in  Avabahuka .Avabahuka can be compared with frozen shoulder in modern medicine .In frozen shoulder it is believed to involve synovial membrane inflammation and fibrosis of the shoulder joint capsule.VIddha Karma involves puncturing the skin with a needle .Viddha karma eliminates the obstruction of vatadi dosha and removes the vitiated dosha from the body.Hence Viddha karma and Agnikarma can be an  inmoduled as a proper treatment method for treating Avabahuka.  
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