FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023407 [Registered on: 18/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   effects of ayurvedic nasal drop therapy and trayodashang guggulu for treating frozen shoulder. 
Scientific Title of Study   Comparative study to evaluate the efficacy of Mahamasha Taila Nasya with Trayodashanga Guggulu in Avabahuka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tinkle Rani 
Designation  PG Scholar 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar

South West
DELHI
110073
India 
Phone  8506991603  
Fax    
Email  tinklekhowal.tk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishakha Rajesh Wetal 
Designation  Associate Professor 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Room No 143 first floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar

South West
DELHI
110073
India 
Phone  9518528493  
Fax    
Email  vishakhawetal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishakha Rajesh Wetal 
Designation  Associate Professor 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Room No 143 first floor Department of Panchakarma Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar

South West
DELHI
110073
India 
Phone  9518528493  
Fax    
Email  vishakhawetal@gmail.com  
 
Source of Monetary or Material Support  
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar Najafgarh New Delhi-110073 
Type of Sponsor  Government 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 tinkle rani  ch brahm prakash ayurved charak sansthan  Panchakarma Department therapy section room no 238
South West
DELHI 		 8506991603

tinklekhowal.tk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethical Committee-Ch Brahm Prakash Ayurved Charak Sansthan  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mahamasha Taila Nasya with Trayodashang Guggulu  Mahamasha Taila Nasya 4ml each nostril daily for seven days two sessions of Nasya ith rest period of seven days in between Trayodashang Guggulu with ushnodaka in dose of 3 gm in divided doses for 21 days 
Comparator Agent  Trayodashang Guggulu with Ushnodaka  Trayodashang Guggulu with ushnodaka in dose of 3 gm in divided doses for 21 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having the sign and symptoms of Avabahuka as Bahupraspanditahara (limited range of motion of the upper limb) and Amsa Shoola (pain in shoulder region), for more than one month and Patients fit for Nasya karma as per the text (Charaka Samhita Sidhi Sthana 2/22).
 
 
ExclusionCriteria 
Details  Patients of shoulder joint dislocation/fracture or has the history for the same, Pregnant women and lactating mothers, Patients suffering from major systemic disorders eg IHD, RA, Gout, SLE and Malignant and Immuno-compromised patients (AIDS).
5. Patients unfit for Nasya as with any anatomical deformity of the nasal passage e.g. cleft palate.
6. Patients with uncontrolled Diabetes Mellitus.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the reduction in SPADI Score.  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the reduction in gradings of Bahupraspanditahara (limited range of motion of shoulder joint)and amsa shula (pain in shoulder region)  28 days 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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/ Phase 3 
Date of First Enrollment (India)   18/02/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is a open label parallel group trial comparing the efficacy of Mahamasha Taila Nasya with Trayodashang Guggulu in Avabahuka. in one group Mahamasha Taila Nasya in the dose of 4 ml each nostril daily for two sessions of Nasya each comprising for seven days with the rest period of seven days in between two sessions, will be given. in another group Trayodshang Guggulu with Ushnodaka in dose of 3 gm in daily divided dose will be given. The trail will be conducted in Ch Brahm Prakash Ayurved Charak Sansthan India with primary outcome of improvement in SPADI score and secondary outcome of improvement in Bahupraspandita Hara (limited range of motion of the shoulder joint) and Amsa Shula (pain in shoulder joint).  
Close