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CTRI Number  CTRI/2025/08/092843 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring Basti Techniques in Low Back Pain Management: An Analytical Comparison 
Scientific Title of Study   Comparative Efficacy of Different Basti Techniques within the kala Basti pattern in low Back pian: An Analytical Cross-sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Gopesh Mangal 
Designation  Professor and Head of Department 
Affiliation  National Institute of Ayurveda (De Novo) Jaipur 
Address  Prof Gopesh Mangal Professor and Head Department of Panchakarma National Institute of Ayurveda (De Novo) Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gopesh.pk@nia.edu.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Anusree D 
Designation  Panchakarma Vaidya 
Affiliation  National Institute of Ayurveda (De Novo) Jaipur 
Address  Dr Anusree D Panchakarma Vaidya National Institute of Ayurveda (De Novo) Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8547372325  
Fax    
Email  anusree.pk@nia.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Anusree D 
Designation  Panchakarma Vaidya 
Affiliation  National Institute of Ayurveda (De Novo) Jaipur 
Address  Dr Anusree D Panchakarma Vaidya National Institute of Ayurveda (De Novo) Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8547372325  
Fax    
Email  anusree.pk@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda (De Novo), Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda De Novo 
Address  National Institute of Ayurveda Deemed to be University JorawarSingh Gate Madhav Vilas Palace Amer Road 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 ANUSREE D  National Institute of Ayurveda Jaipur  Department of Panchakarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN 		 8547372325

anusree.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 JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 60 years
Patients presenting with a primary complaint of Low Back Pain (LBP)
Patients with a confirmed diagnosis of LBP based on clinical evaluation and/or imaging studies
Patients scheduled to undergo Basti therapy within the Kala Basti pattern as part of their treatment regimen
Patients willing to provide informed consent for
participation in the study 
 
ExclusionCriteria 
Details  Patients with contraindications to Basti therapy
Patients with a history of significant spinal pathology (vertebral fractures, spinal tumors), severe systemic illness, active infection, or uncontrolled bleeding disorders
Patients with a history of adverse reactions or
hypersensitivity to the substances commonly used in Basti formulations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Oswestry Low Back Disability Questionnaire, The Quebec Back Pain Disability Scale  Base line and 16th day 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life - SF 36   Base line & 16th day 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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)   20/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Primary purpose of protocol: To determine the relative 
effectiveness of various Basti formulations within the Kala 
Basti pattern for reducing Low Back Pain (LBP). Additionally, 
the study aims to assess the influence of Basti therapy on 
outcomes measured by the Oswestry Low Back Disability 
Questionnaire, The Quebec Back Pain Disability Scale, and 
SF-36 among individuals with LBP. 
 

 
 
The methodology of this study involves a comparative analysis 
of different Basti formulations within the Kala Basti pattern for 
managing Low Back Pain (LBP). Participants will be recruited 
and grouped based on specific Basti techniques administered. 
Data on pain intensity, functional disability, and quality of life 
will be collected using validated scales such as the Oswestry 
Low Back Disability Questionnaire, The Quebec Back Pain 
Disability Scale, and SF-36. Statistical analyses will be 
employed to compare the effectiveness of Basti formulations 
and assess their impact on LBP outcomes. Additionally, 
subgroup analyses may be conducted to explore the influence 
of potential confounding factors. 
 
Dissemination of findings: The findings of the study will be 
disseminated through peer-reviewed publications, conference 
presentations, and knowledge-sharing platforms within the 
Ayurvedic community to inform practice, policy, and future 
research endeavors.
 
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