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CTRI Number  CTRI/2025/10/096626 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role Of Panchatikta Ksheera basti And Patra Pottali Swedana In Janu Sandhigata Vata (Knee Osteoarthritis) 
Scientific Title of Study   Comparative Clinical Evaluation Of Panchatikta Ksheera Basti And Patra Pottali Swedana In Janu Sandhigata Vata (Knee Osteoarthritis) 
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 Pravesh Kumar 
Designation  Associate Professor (Panchkarma) 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  O.P.D No 20 P.G. Department Of Panchkarma, Rishikul Campus, Haridwar,Uttarakhand Ayurved University (Deharadun) Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7417935825  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravesh Kumar 
Designation  Associate Professor (Panchkarma) 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  O.P.D No 20 P.G. Department Of Panchkarma, Rishikul Campus, Haridwar,Uttarakhand Ayurved University (Deharadun) Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7417935825  
Fax    
Email  praveshk312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Swati Rawat 
Designation  MD Scholar 
Affiliation  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  O.P.D No 20 P.G. Department Of Panchkarma, Rishikul Campus, Haridwar, Uttarakhand Ayurved University (Deharadun) Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  8449129928  
Fax    
Email  swatijangpangi4@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Ayurvedic college Rishikul Campus UAU Haridwar 249401  
 
Primary Sponsor  
Name  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Rishikul Campus, Haridwar, Uttarakhand, India 249401 
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 Swati Rawat  Rishikul Campus, Haridwar  OPD NO.20 Department of Panchkarma Rishikul Campus Haridwar UAU 249401
Hardwar
UTTARANCHAL 		 8449129928

swatijangpangi4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Rishikul Campus, Haridwar, Uttarakhand Ayurved University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma बJ6कम./वJ6कम (Procedure Reference: Charak Samhita Sutra Sthan 28/27, Procedure details: Panchatikta Ksheera basti along with Anuvasana basti of Murchit tila taila will be administered in Yoga basti manner. Before administering the basti dravya sthanik abhyang with murchit tila taila & bashpa sweda will be done. after ksheera basti pratyagamana ushna jal snan & laghu bhojan will be advised. after anuvasana basti sphik tadana, mardana of sole & palm will be done. Panchatikta ksheera basti dose- 480 ml Anuvasana basti dose- 120ml)
2Comparator ArmProcedure-sa~gkarasvedaH संकरeेदः (Procedure Reference: Charak samhita chikitsa sthan 28/78, Procedure details: Patient will be asked to sit on droni with his leg extended. Abhyang with Murchita tila taila will be performed on affected part for 10 minutes. prepared pottali will be heated with murchita tila taila in a hot iron pan. after checking the temerature over dorsum of hand it will be applied over affected part with mild pressure for a period of 30-40 minutes till sweating appears. after procedure oil will be wiped off from the body using clean dry towel & hot water bath will be advised to the patient. )
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having sign symptoms of Janu Sandhigata Vata.
2. Age: between 40- 65 years.
3. Patients with radiological finding of Osteoarthritis.
4. Patients willing to participate in the study and provide informed consent 
 
ExclusionCriteria 
Details  1. Known case of accidental injury or trauma and chronic debilitating disease like Tuberculosis, uncontrolled Diabetes mellitus, Rheumatoid arthritis, Gout, Cancer etc.
2. Cases which require surgical intervention.
3. Patient unfit for Basti and Swedana Karma.
4. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE PARAMETERS
1. Pain
2. Swelling
3. Crepitus
4. Stiffness
Relief in the above sign and symptoms  		 Follow up after 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
OBJECTIVE PARAMETERS
Goniometry readings and visual analogue score to be reduced 		 Follow up after 1 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/11/2025 
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="6"
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   This is an open randomized comparative clinical study to evaluate the efficacy of Panchatikta Ksheera Basti and Patra pottali Swedana in Janu Sandhigata Vata (Knee osteoarthritis).This study will be conducted upon 40 randomly selected patients from OPD/IPD of Panchkarma department of Rishikul Ayurvedic College and Hospital, Rishikul Campus, Haridwar based on inclusion and exclusion criteria. Patients will be divided into 2 groups. In Group A- 20 Patients will be given Panchatikta Ksheera basti and in Group B- 20 patients will be given Patra Pottali Swedana. The duration of treatment will be of 33 days. Follow up study will be conducted 1 month after the treatment.  Assessment will be done on the basis of Subjective and Objective parameters. 
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