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CTRI Number  CTRI/2024/03/063989 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Avabahuka management through ayurveda  
Scientific Title of Study   A controlled clinical study to evaluate the efficacy of Kkarpasasthayadi taila nasya along with rasnadi guggulu in the management of avabahuka 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 Sonam pathariya 
Designation  MD Scholar 
Affiliation  Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP 
Address  PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP

Bhopal
MADHYA PRADESH
462003
India 
Phone  7999313434  
Fax    
Email  pathariyasonam35@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Sharma 
Designation  Lecturer 
Affiliation  Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP 
Address  PG Department of Kayachikitsa Pt. Khushilal Sharma Government College and Institute Bhopal MP

Bhopal
MADHYA PRADESH
462003
India 
Phone  9827937247  
Fax    
Email  drvivek.sharma13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonam Pathariya  
Designation  MD Scholar 
Affiliation  Pt khushilal sharma government ayurveda college and institute Bhopal MP 
Address  PG Department of Kayachikitsa Pt. Khushilal Sharma Government College and Institute Bhopal MP

Bhopal
MADHYA PRADESH
462003
India 
Phone  7999313434  
Fax    
Email  pathariyasonam35@gmail.com  
 
Source of Monetary or Material Support  
Pt. Khushilal Sharma Government Autonomous Ayurveda College And Institute, Bhopal (M.P.) 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP  
Address  PG Department of Kayachikitsa Pt. Khushilal Sharma Government College and Institute Bhopal MP 
Type of Sponsor  Government funding agency 
 
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 Sonam Pathariya  Pt. Khushilal Sharma Government Ayurveda Hospital Bhopal MP  Room No. 221 PG Department of Kayachikitsa Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal MP
Bhopal
MADHYA PRADESH 		 7999313434

pathariyasonam35@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pt Khushilal Sharma Govt Ayurveda College & Institute Bhopal MP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Physiotherapy SWD - Short Wave Diathermy one time in a day 10 -12 minutes / 30 days Mobilization IFT - Interferential Therapy one time in a day 10 - 12 minutes / 30 day
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Vidyanath R. Sahasrayogam, Procedure details: Nasya Administration, Karpasasthayadi Taila)
(1) Medicine Name: Rasnadi Guggulu, Reference: Yogratnakara, Route: Oral, Dosage Form: Guggulu, Dose: 250(mg), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients have classical sign & symptoms of Avabahuka
Patients fit for Nasya Karma.
Patients willing to sign written consent form for participation in the study.
 
 
ExclusionCriteria 
Details  Either gender less than 30 and exceeding 60 years.
Pregnant & Lacting Women.
Dislocation and fracture affecting the shouler joint.
Patients with any disorders, which interfere the line of treatment of Avabahuka like OA etc. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Avabahuka is one among the vata pradhan vyadhi. It is characterised by bahu praspandanhara, shula and amsashosha.Avabahuka is considered to be a disease that usually affects the shoulder joint (amsa sandhi) and is produced by the Vata dosha.It is expected at the end of the study we should be able to demonstrate the efficacy of Ayurvedic treatment protocol in the management of Avabahuka (Frozen Shoulder).
RBS
X-ray 		 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Pain
Stiffness of the shoulder
Range of motion 		 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   25/03/2024 
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 Yet Recruiting 
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   It is expected that at the end of the study we would be able to demonstrate the efficacy of ayurvedic treatment protocol in the management of Avabahuka (Frozen Shoulder) 
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