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CTRI Number  CTRI/2023/01/048704 [Registered on: 03/01/2023] Trial Registered Prospectively
Last Modified On: 02/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Curative]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare the combined effect of viddha plus agnikarma with only viddha karma in avabahuka special reference to frozen shoulder 
Scientific Title of Study   A randomized comparative clinical trial to evaluate combined efficacy of viddha karma plus agnikarma with only viddha karma in avbahuka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneha Jadhav 
Designation  PG Scholar 
Affiliation  PDEAS College of Ayurved and Research Centre, Nigdi, Pune 
Address  PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044

Pune
MAHARASHTRA
411044
India 
Phone  08390616669  
Fax    
Email  jsneha58@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi S Banarase 
Designation  HOD Shalyatantra Department 
Affiliation  PDEAS College of Ayurved and Research Centre, Nigdi, Pune 
Address  PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044

Pune
MAHARASHTRA
411044
India 
Phone  9423207569  
Fax    
Email  dr.madhavibanarase209@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sneha Jadhav 
Designation  PG Scholar 
Affiliation  PDEAS College of Ayurved and Research Centre, Nigdi, Pune 
Address  PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044

Pune
MAHARASHTRA
411044
India 
Phone  08390616669  
Fax    
Email  jsneha58@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurved and Research Centre, sector no. 25, Pradhikaran, Nigdi, Pune 411044 
 
Primary Sponsor  
Name  PDEAS College of Ayurved and Research Centre, Nigdi Pune 
Address  PDEAS College of Ayurved and Research Centre, Sec.no.25 Pradhikaran, Nigdi, Pune 411044  
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 Sneha Jadhav  Ayurved Rugnalay and Sterling Multispeciality Hospital  Shalyatantra OPD, OPD no. 123, ground floor, Sector.27, bhel chowk, pradhikaran, nigdi, pune 411044
Pune
MAHARASHTRA 
08390616669

jsneha58@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
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: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म plus vedhan karma (Procedure Reference: SUSHRUT SAMHITA, Procedure details: Most tender point will be marked then cleaned with spirit swab and disposable needle will be pierced at 45 degrees of angle upto 3 to 4 mm depth and then later Agnikarma will be done with panchdhatu shalaka in once a week for 21 days.)
2Comparator ArmProcedure-vedhana-karma, वेधन-कर्म (Procedure Reference: SUSHRUT SAMHITA, Procedure details: Most tender point will be marked then cleaned with spirit swab and disposable needle will be pierced at 45 degrees of angle upto 3 to 4 mm depth in once a week for 21 days.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed as frozen shoulder.(adhesive capsulitis)
Patients of age group 20-60 years.
Patients irrespective of gender, caste, religion, economical status.
All patients having pain and restricted movements at shoulder joint in presence of
normal plane. 
 
ExclusionCriteria 
Details  Pregnancy
Patient suffering from major trauma having dislocation, Rotator cuff injury or fracture.
Patient suffering from any major systemic disorders like, Hypertension, Ischemic Heart
disease, Gout and rheumatoid arthritis.
Those patients who need other emergency interventions like surgery and other means
are excluded.
K/C/O HIV, HBsAg.
Patient with Malignancy and Immuno-compromised disorders.
Patients with uncontrolled Diabetes mellitus 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
In once a week for 21 days the effect of Viddha karma plus Agnikarma on the Avabahuka pain relief will be accessed with the effect of only viddha karma.  Total 21 days treatment
Difference in pain and stiffness will be observed on 0, 7th, 14th, and 21st day. 
 
Secondary Outcome  
Outcome  TimePoints 
To study adverse effects, if any  Total 21 days treatment
Difference in pain and stiffness will be observed on 0, 7th, 14th, and 21st day. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   05/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In textual refrences of Ayurveda, Avabahuka is described as vata vadhi in which vata dosha is localized in the shoulder region, when Vata gets vitiated, it dries up the ligaments of the shoulders and constricts the Siras present there and causes Avabahuka.
In modern, Frozen shoulder is a condition characterized by stiffness and pain in the shoulder joint. Frozen shoulder is also called adhesive capsulitis as the shoulder capsule thickens and becomes stiff and tight. Thick bands of tissue called adhesions develop. This typically occurs in cycle of 3 stages as painful phase, stiff phass and thawing phase which can be correlated to avabahuka in ayurveda.
In Ayurveda literature, Acharya Sushruta has given the description of Viddha karma and Agnikarma as a parasurgical procedures are unique therapeutic procedures because of its primitive, preventive and prophylactic properties.
•Viddha Karma - viddha karma is a miniature of bloodletting procedure. A very small puncture or piercing certain points that helps in reducing pain. It acts as pain reliever by releasing Endorphin that helps to reduce pain in body.
• Viddha karma plus Agnikarma- With Viddha karma Agnikarma can be done in circular manner, or Appling dot at most tender point or parallel linings at the tender point.
So viddha karma and agnikarma to the maximum tenderness points of shoulder may release the Vataavrodha and ultimately pain will be decreased. When pain is relieved, the patient will definitely try to make the active movements of his arm.
 
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