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CTRI Number  CTRI/2024/06/069615 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 20/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Pain Management through Ayurveda In Ankylosing Spondylitis. 
Scientific Title of Study   An Open Labelled Clinical Study To Evaluate The Efficacy Of Virechana Karma Followed By Baladi Yapna Basti With Prishtha Dhara In The Management Of Kati-Prishtha-Trika Graha With Special Reference To Ankylosing Spondylitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneh Kanwar Rathore 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  Room No. 114, Panchkarma Department, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9351049597  
Fax    
Email  rathoresneha467@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopesh Mangal 
Designation  PROFESSOR AND HOD,PANCHKARMA DEPARTMENT 
Affiliation  National Institute Of Ayurveda 
Address  Room No. 114, Panchkarma Department, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gopesh.pk@nia.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Gopesh Mangal 
Designation  PROFESSOR AND HOD,PANCHKARMA DEPARTMENT 
Affiliation  National Institute of Ayurveda 
Address  Room No. 114, Panchkarma Department, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gopesh.pk@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav Vilas palace ,Amer road,joravar Singh gate , Jaipur (Rajasthan), India PIN code 302022  
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  National Institute Of Ayurveda,amer road ,joravar Singh gate ,Jaipur(Rajasthan) India PIN code 302022 
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 Gopesh Mangal  National Institute of Ayurveda  OPD No 2, Panchkarma OPD National Institute of Ayurveda Hospital Block, Madhav Vilas Palace,Joravar Singh Gate,Amer Road,Jaipur.
Jaipur
RAJASTHAN 		 8619849011

gopesh.pk@nia.edu.in 
 
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. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita siddhi sthana uttar basti siddhi adhyaya 12/6, Procedure details: deepana pachana with panchkola churna 3 to 7 days then snepana with shudha goghrita as per koshtha & agni 3 to 7 days followed by sarvanga abhyanga with dashmoola taila and swedana with dashmoola bashpa for 4 days followed by virechana karma with eranda taila and triphala kwatha samsarjana karma as per shuddhi then prishtha dhara with bhutikadi taila for 14 days kaala basti with baladi yapna basti and bhutikadi taila anuvasana basti )
(1) Medicine Name: eranda taila , Reference: chakradatta virechanadhikara 71, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: triphala kwatha, Reference: chakradatta virechanadhikara 71, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having symptoms of Kati-Prishtha-Trika Graha.
Patient having sign and symptoms of Ankylosing spondylitis.
Chronicity: Less than 10 years.
Patients indicated for Virechana,Basti Karma and Prishtha Dhara.
Age 18-60 years.
 
 
ExclusionCriteria 
Details  Patients having serious Cardiac, Renal or Hepatic diseases, uncontrolled Hypertension,
Diabetes.
Pregnant & lactating women.
Patients contraindicated for Virechana, Basti Karma and Prishtha Dhara.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes In Lumbar Spine Motion   15th day from completion of procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in :
1.Pain
2.Stiffness
3.Quality of life 		 15th day from completion of procedure  
 
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   N/A 
Date of First Enrollment (India)   22/07/2024 
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="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Ankylosing spondylitis is a type of arthritis that causes inflammation in the joints and ligaments of the spine. It may also affect peripheral joints like the knees, ankles, and hips. Normally, the joints and ligaments in the spine help us move and bend. If you have ankylosing spondylitis, the inflammation in the joints and tissues of the spine can cause stiffness. In severe cases, this may cause the vertebrae (bones in the spine) to fuse (grow together). When the vertebrae fuse, it can lead to a rigid and inflexible spine. The most common symptom of ankylosing spondylitis is lower back and/or hip pain and stiffness. Over time, the symptoms may progress to other areas of the spine or body. The pain typically worsens during periods of rest or inactivity, which may cause some people to experience more pain during the middle of the night or after prolonged sitting. Usually, moving and exercise can help improve pain. On the basis of pathogenesis and Symptoms can be correlated to clinical conditions Pravruddha Amavata (TrikSaruja Shotha),Asthimajjagata Vata (Asthi, parva bheda,Sandhishoola, Aswapna, Satat ruk, Vinaamta), Kaphavrit Vyana (Guruta Sarvagatranam, Kati Sarva Sandhyasthi Ruja, Gatisanga) mentioned in classical texts.
 But due to the maximum proximity of symptoms and pathology,  AS in present study is being correlated to Kati-Prishtha-TrikaGraha. 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 Ayurveda, Graha (Stiffness) is one of the characteristic features of aggravated Vata associated with Ama Dosha.
AIM:
To evaluate the efficacy of Virechana karma followed Baladi YapnaBasti, Bhutikadi Taila Anuvasna Basti and Prishtha Dhara in the management of Kati-Prishtha-Trika graha (Ankylosing Spondylitis)
OBJECTIVE:
To evaluate the efficacy of Virechana Karma followed by Baladi Yapna Basti, Bhutikadi Taila Anuvasna Basti and Prishtha Dhara in the management of Kati-Prishtha-Trika Graha with special reference to Ankylosing spondylitis
RESEARCH QUESTION:
Is there any efficacy of Virechana Karma followed by Baladi Yapna Basti , Bhutikadi Taila Anuvasna Basti and Prishtha Dhara in tha management of Kati Prishtha-Trik Graha (Ankylosing Spondylitis)?
HYPOTHESIS:
Null Hypothesis [H0]: There is no efficacy of Virechana Karma followed by Baladi Yapna Basti,  Bhutikadi Taila Anuvasna Basti and Prishtha Dharain the management of Kati-Prishtha-Trik Graha(Ankylosing Spondylitis)
Alternative Hypothesis [HA]: There is significanct efficacy of Virechana karma followed by Baladi Yapna basti , Bhutikadi Taila Anuvasna Basti and Prishtha Dhara in the management of Kati-Prishtha Trik Graha (Ankylosing Spondylitis)
 
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