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
|
|
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
|
|
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. |