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CTRI Number  CTRI/2025/07/091111 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study to see the effect of retention time of enema and its outcome in knee joint pain 
Scientific Title of Study   An open labelled single arm interventional clinical study to assess the effect of prathyagamana kala of anuvasana basti and its outcome in janu sandhigata vata vis-a-vis osteoarthritis of knee joint 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakshitha O 
Designation  Post Graduate Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028

Mysore
KARNATAKA
570028
India 
Phone  07259544100  
Fax    
Email  rakshuom98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seetha Devi P 
Designation  Reader 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028

Mysore
KARNATAKA
570028
India 
Phone  8431444499  
Fax    
Email  drsitadevi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seetha Devi P 
Designation  Reader 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD2 Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028

Mysore
KARNATAKA
570028
India 
Phone  8431444499  
Fax    
Email  drsitadevi@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028  
 
Primary Sponsor  
Name  Dr Rakshitha O 
Address  Department of Panchakarma,JSS ayurveda hospital # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028  
Type of Sponsor  Other [self] 
 
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 Rakshitha O  JSS Ayurveda College and Hospital  Room no 2,Department of Panchakarma OPD, # 41/ E,Lalithadripura Road, Mysuru, Karnataka 570028
Mysore
KARNATAKA 
07259544100

rakshuom98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, JSS Ayurveda Medical College, Mysuru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: Caraka Samhita SiddhiStana 4, Procedure details: Purvakarma:Stanika Abyanga Pradhana Karma: Anuvasana Basti 100ml with Balaaswagandhalakshadi Taila from Day 1 to 8. Paschat Karma: When the administration is over, buttocks of the patient are patted with palms for three times and is advised to relax in supine position.then pillow is kept under the head of the patient and soles of the patient are gently rubbed. In this relaxed position patient should wait for 100 Vak (time taken to count up to 100), The patient may be allowed to take rest on the comfortable bed.)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects fulfilling the diagnostic criteria.
Subjects of either gender, aged between 30-70 years.
Subjects fit for Basti karma.  
 
ExclusionCriteria 
Details  Traumatic, Infective, Neoplastic, Congenital diseases of joint and Rheumatoid
arthritis, Psoriatic arthritis.
Subjects with systemic disorders which interfere with the course of treatment.
Pregnant and lactating women.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess the effect of retention period of anuvasana Basti and its outcome in janusandhigata vata  To Assess the effect of retention period of anuvasana Basti for 8 days and its outcome in janusandhigata vata 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess the improvement in signs & symptoms of janusandhigata vata  9th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/07/2025 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
       Basti chikitsa which is being called Ardha Chikitsa is considered as the best treatment for Vata Vyadhi. Anuvasana basti is a type of Snehabasti which is indicated in Vata vikaras. Janusandhigata vata is one among the vata vyadhi characterized by sandishula, shotha, vedana during prasarana and akunchana of sandhi, vatapurna druthi sparsha and occurs mostly in old age due to Dhatukshaya which limits a person’s routine activities. Acharya Charaka has mentioned the use of Snehana, Swedana, Basti and Mruduvirechana as the treatment of Vatavyadhi. Janusandhigata vata can be correlated to Osteoarthritis of Knee Joint. Osteoarthritis of Knee Joint is characterized by focal loss of Articular Cartilage, Subcondral osteosclerosis, osteophyte formation at the joint margin and remodelling of joint contour with enlargement. Principally targets the patella-femoral and medial tibio-femoral compartments but eventually spreads to affect the whole of the joint. 
       The prevalence of osteoarthritis of Knee Joint rises progressively with age and it has been estimated that 45% of all people develop knee osteoarthritis at some point during life. Management includes Analgesics/topical NSAID, Oral NSAID, Joint replacement surgery, Strengthening exercises, etc. Now a days because of multiple influencing factors and bala of the patient, 1152ml/Dwadasha prasrutika niruha quantity is rarely practiced. Approximately 100ml will be given as anuvasana basti considering the routine practice of 8 to 9 prasruta quantity of niruha basti. Balaashwagandhalakshadi taila which is mentioned in Sahasrayoga is indicated in Vata vikaras. So, this study is intended to Assess the Prathyagamana kala of Balaashwagandha lakshadi taila anuvasana basti and its outcome in Janu sandhigata vata  
 
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