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CTRI Number  CTRI/2019/02/017768 [Registered on: 21/02/2019] Trial Registered Prospectively
Last Modified On: 07/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Ankylosing Spondylitis through Ayurveda  
Scientific Title of Study   An Open Label Randomized Clinical Study to evaluate the efficacy of Patrapinda Swedana and Erandamooladi Basti followed by Shamana with and without Virechana in the management of Kati-Prishtha-Trik Graha with special reference to Ankylosing Spondylitis. 
Trial Acronym  ASP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karishma Singh 
Designation  PhD Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  KARISHMA SINGH,DEPARTMENT-PANCHKARMA,NATIONAL INSTITUTE OF AYURVEDA, JAIPUR, RAJASTHAN PIN-302002

Jaipur
RAJASTHAN
302002
India 
Phone  8368749544  
Fax    
Email  dr.tejas01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  H.O.D. I/C, Department of Panchakarma, National Institute of Ayurveda. 
Affiliation  National Institute of Ayurveda 
Address  Department of Panchakarma, National Isntitute of Ayurveda, Jaipur, Rajasthan- 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karishma Singh 
Designation  PhD Scholar 
Affiliation  National Institute of Ayurveda 
Address  KARISHMA SINGH,DEPARTMENT-PANCHKARMA,NATIONAL INSTITUTE OF AYURVEDA, JAIPUR, RAJASTHAN PIN-302002

Jaipur
RAJASTHAN
302002
India 
Phone  8368749544  
Fax    
Email  dr.tejas01@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur, Rajasthan-302002. 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jaipur, Rajasthan-302002 
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 Karishma Singh  National Institute of Ayurveda  OPD No. 2, NIA Hospital, Jaipur
Jaipur
RAJASTHAN 
8368749544

dr.tejas01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, national Institute of Ayurveda  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 
Intervention  Group A  Patrapinda Swedana for 7 days, Virechana, Erandamooladi Basti for 16 days, Shamana for one month (Rasnasaptak Kashaya 40 ml orally twice daily and Trayodashanga Guggulu 1gm orally thrice daily) 
Comparator Agent  Group B  Patrapinda Swedana for 7 days, Erandamooladi Basti for 16 days, Shamana for one month (Rasnasaptak Kashaya 40 ml orally twice daily and Trayodashanga Guggulu orally 1gm thrice daily)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling the Assessment of Spondylo Arthritis International Society (ASAS) criteria for Ankylosing Spondylitis, or pre-diagnosed cases.
Patient having symptoms of Kati-Prishtha-Trik Graha, Patient having sign and symptoms of Ankylosing spondylitis, Chronicity: less than 10 yearsPatients indicated for Patrapinda Swedana, Virechana and Basti Karma.
 
 
ExclusionCriteria 
Details  Patients having serious Cardiac, Renal or Hepatic diseases, uncontrolled Hypertension, Diabetes. Pregnant & lactating women.
Patients contraindicated for Patrapinda Swedana, Virechana and Basti Karma.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in lumbar flexion  100 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in Pain, Stiffness  100 days 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   15/03/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Ankylosing spondylitis (AS) or Marie Strumpell Disease is a chronic inflammation of the spine that primarily involves the sacroiliac joints and the axial skeleton. The clinical features of AS can be divided in spinal and extra spinal features. The spinal involvement results in complaints of chronic inflammatory back pain with morning stiffness. This morning stiffness lasts at least one hour, but often many hours, and improves with exercise but is not relieved by rest. Nocturnal exacerbation of pain that forces the patient to rise and move may be frequent. Pain at the cervical region and of the thoracic spine, especially with chest expansion, is caused by involvement of the cervical and costovertebral joints. The spinal inflammation coincides with the formation of syndesmophytes and squaring of the vertebrae, sometimes evolving into the classical bamboo spine, can lead to spinal ankylosis with a limited chest expansion, limited neck motion, flattening of the lumbar spine and thoracic kyphosis. There is no direct correlation of Ankylosing spondylitis mentioned in Ayurveda. But due to the maximum proximity of symptoms and pathology, AS in present study is being correlated to Kati-Prishtha-Trik-Graha mentioned in classics. Shoola (Pain), and Graha (Stiffness) in Kati (Pelvis), Prishtha (Posterior region of trunk from neck to pelvis), and Trik pradesha (Region around shoulder girdle) are the cardinal features of Ankylosing Spondylitis. In Ayurved, Graha (Stiffness) is one of the characteristic features of aggravated Vata and Kapha Dosha. Hence in the treatment of Kati-Prishtha-Trik Graha (Ankolysing Spondylitis), primary concern should be effective treatment of Kapha and Vata Dosha, which includes sequential administration of Swedana, Srotoshodhana and Basti. The present study will be conducted on 38 pre-diagnosed cases of Ankylosing spondylitis or those fulfilling the Spondylo Arthritis International Society (ASAS) criteria for Ankylosing Spondylitis. The patients will be randomly divided into 2 Groups. Patients in Group A will be treated with Patrapinda Swedana, Virechana, Erandamooladi Basti and Shamana therapy, while Patients in Group B will receive the same treatment except Erandamooladi Basti. Assessment will be carried out before and after treatment. Observations will be recorded, compared and will be statistically tested. Final conclusion will be drawn after the statistical analysis of the observations.
 
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