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CTRI Number  CTRI/2019/06/019786 [Registered on: 20/06/2019] Trial Registered Prospectively
Last Modified On: 16/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management regime of Ankylosing Spondylitis. 
Scientific Title of Study   A Comparative Clinical Study on the efficacy of Vaaluka Svedana followed by Kati-pristha-trikabasti with or without Erandamooladi Yogabasti in the management of Kati-Pristha-Trika Graha w.s.r. to Ankylosing Spondylitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Bansal 
Designation  Pg Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Panchakarma,OPD no 6, Ground Floor, Gautam Puri,Sarita VIhar,New Delhi-110076

North West
DELHI
110076
India 
Phone  9560370553  
Fax    
Email  naveenbansal707@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santoshkumar Bhatted 
Designation  Head of Department, Department of Panchakarma 
Affiliation  All India Institute of Ayurveda 
Address  Department of Panchakarma, 7th floor,Academic Block Gautampuri, Sarita Vihar, Mathura road, NEW DELHI-110076

South West
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanth Dharmarajan 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Panchakarma, 7th floor,Academic Block Gautampuri, Sarita Vihar, Mathura road, NEW DELHI-110076

South West
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, NEW DELHI-110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita Vihar, Mathura road, NEW DELHI-110076 
Type of Sponsor  Research institution and hospital 
 
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 Naveen Bansal  All India Institute of Ayurveda  Opd no. 6,Hospital Block,Gautampuri, Sarita Vihar, Mathura road, New Delhi-110076
South West
DELHI 
9560370553

naveenbansal707@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: M450||Ankylosing spondylitis of multiplesites in spine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Vaaluka Svedana followed by Kati-Pristha-Trikabasti   Vaaluka Svedana followed by Kati-Pristha-Trika Basti with Dhanwantharam taila each for a period of 7 days for 30 minutes daily followed by Simhanad Guggulu 2 tab. twice a day and Rasna Saptak Kwatha 40 ml twice a day for 15 days. 
Intervention  Vaaluka Svedana followed by Kati-Pristha-Trika Basti followed by Erandamooladi Yogabasti  Vaaluka Svedana followed by Kati-Pristha-Trika Basti with Dhanwantharam taila each for a period of 7 days for 30 minutes daily followed by Erandamooladi Yogabasti for 8 days followed by Simhanad Guggulu 2 tab. twice a day and Rasna Saptak Kwatha 40 ml twice a day for 15 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1 Duration of the disease: 1yr to 10 years

2 Socio- economic status: All

3 Diagnosed cases of Ankylosing Spondylitis
 
 
ExclusionCriteria 
Details  1 Chronicity of disease more than 10 yrs.

2 Severely deformed joints.

3 Cardiac disease, pulmonary tuberculosis,
severe lung disease and pregnant women.

4 Patients unfit for Snehana,Svedana and Basti
Karma.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain  67 days 
 
Secondary Outcome  
Outcome  TimePoints 
Overall improvement in quality of life

 
67 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2019 
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   Article will be published later in reputed journal. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ankylosing spondylitis (AS) is a systematic rheumatic disorder, which is characterized clinically by pain and stiffness of the back, and radiologically by arthritic changes in the sacroiliac joints and the entire spine. The chronic inflammation leads to progressive ossification of the spinal ligaments and facet joints.

Kati-Pristha-Trika Graha may be considered similar to Ankolysing Spondylitis in Ayurveda.Graha is one of the characteristic features of aggravated Vata Dosha.Moreover Kati,Prishtha and Trika are the places of Asthi Sandhi which again are the places for localisation of aggravated Vata Dosha.Graha/Stambha could be seen when Kaphavritta Vata condition develops.Hence in the treatment of Kati-Pristha-Trika Graha(Ankolysing Spondylitis), primary concernshould be effective treatment of Vata Dosha, which includes administration of Snehana, Svedana and Basti.

In this study,patients of ankylosing spondylitis will be taken according to inclusion criteria.Selected patients will be divided into two  groups by permuted block randomization.In first group ,vaaluka svedana followed by katipristhatrika basti with dhanwantharam thailam for 7 days each will be done followed by rasnasaptak kwath and simhanaad guggulun as follow up medications for 15 days.In second group,vaaluka svedana for 7 days will be done followed by katipristhabasti with dhanwantharan thailam for 7 days followed by yogabasti for 8 days.Follow up medications with Simhanaad Guggulu and Rasnasaptak Kwatha will be given for 15 days.In both groups,patients will be assessed as per assessment criteria.

 
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