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CTRI Number  CTRI/2023/03/050228 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 22/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Dashmoolabalamash Taila Nasya in Avabahuka[Frozen Shoulder] 
Scientific Title of Study   A Single Arm Clinical Study to evaluate the efficacy of Dashmoolabalamash Taila Nasya in the management of Avabahuka[Frozen Shoulder] 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sidhi Sharma 
Designation  PG Scholar 
Affiliation  Dr. D.Y.Patil College of Ayurved and Research Centre 
Address  Dr. D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India

Pune
MAHARASHTRA
411018
India 
Phone  7876611218  
Fax    
Email  bhardwajsidhi123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamata Nakade 
Designation  HOD and Professor 
Affiliation  Dr. D.Y.Patil College of Ayurved and Research Centre 
Address  Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India

Pune
MAHARASHTRA
411018
India 
Phone  9850241887  
Fax    
Email  mamta.nakade@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sidhi Sharma 
Designation  PG Scholar 
Affiliation  Dr D Y Patil College of Ayurved and Research Centre 
Address  Dr. D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra,India

Pune
MAHARASHTRA
Dr Sidhi Sharma
India 
Phone  7876611218  
Fax    
Email  bhardwajsidhi123@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Ayurved and Research Centre, sant tukaram nagar, pimpri, Pune 411018 
 
Primary Sponsor  
Name  Dr Sidhi Sharma 
Address  Dr. D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra,India 
Type of Sponsor  Other [[self]] 
 
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 Sidhi Sharma  Dr. D. Y. Patil College of Ayurved and Research Centre  Department of Panchakarma , OPD 9, Dr. D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra,India 411018
Pune
MAHARASHTRA 		 7876611218

bhardwajsidhi123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nAvanam, नावनम् (Procedure Reference: भा.प्र.मध्यमखंड २४/८७, Procedure details: After proper sthanika snehana and swedana, the nasya karma will be done.  Firstly, neck of the patient will be slightly tilted upward i.e. 45⁰.  The nasya oil will be lukewarm by immersing the oil container in hot water.  Then the tip of nose of patient will be raised with middle finger and oil will be poured in the nostril while using the index and ring fingers to close the alternate nostril.  Patient will be advised to inhale the medicated oil slowly.  The whole procedur)
(1) Medicine Name: dashmoolabalamash oil, Reference: भा.प्र.मध्यमखंड २४/८७, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 16(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details   Patients having textual symptoms of Avabahuka and will be taken as a subject to study i.e., Amsa shoola, Amsa stambhta, Aachukanchan Prasarana Kashtata.  
 
ExclusionCriteria 
Details   Patients who having diseases Vishvachi, Sandhigatavata, Aamvata, Manyastambha.
 Patient having history of fracture of shoulder joint will be excluded.
 Patient having known case of uncontrolled diabetes will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Dashmoolabalamaash Tail Nasya in joint restriction using Goniometric measurements.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Dashmoolabalamash Tail Nasya in pain reduction of Avabahuka [Frozen Shoulder] using VAS scale.  7 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   03/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
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 - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhardwajsidhi123@gmail.com].

  6. For how long will this data be available start date provided 03-07-2023 and end date provided 03-07-2028?
    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   Title- A Single Arm Clinical Study to evaluate the efficacy of Dashmoolabalamash Taila Nasya in the management of Avabahuka (Frozen Shoulder).
Study Design-Single arm study.
Number of Participants-32
Duration of study- 07 days.
Assessment will be done on 1st and 7th day of treatment. 


 
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