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CTRI Number  CTRI/2025/09/094385 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Role of Ayurveda gel in Knee joint pain 
Scientific Title of Study   Effect of Gel Containing Plumbago Zeylanica in Mild to Moderate Knee Osteoarthritis –A Single Armed Open Label Pilot Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep L Grampurohit 
Designation  Professor  
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  09964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep L Grampurohit 
Designation  Professor  
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  09964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep L Grampurohit 
Designation  Professor  
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  OPD no 04 and IPD Department of Panchakarma KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  09964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Source of Monetary or Material Support  
KLE AYURVEDA PHARMACY KHASBAG SHAHAPUR BELGAUM 590003 
 
Primary Sponsor  
Name  ICMR Belgaum 
Address  Accounts Department RMRC ICMR Layout, Nehru Nagar, Belagavi, Karnataka 590016. 
Type of Sponsor  Government funding agency 
 
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 Pradeep L Grampurohit  KLE Ayurveda Hospital and MRC   OPD no 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and MRC Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA 		 09964144197

pradeepgrampurohit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHERS Shri B M Kankanwadi Ayurveda mahavidhyalaay, Belgaum   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Pulbago Gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Twice in a Day for a period of 7days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Mild and Moderate cases of knee osteoarthritis
Willing to give consent for participating in the study
Patients who are currently on analgesics NSAID will be given a washout period of 8 days prior to recruitment 
 
ExclusionCriteria 
Details  Patients having severe knee osteoarthritis
Those who are suffering from dermatitis or had a history of dermatitis
Pregnant and lactating women
Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain (VAS) Tenderness Shotha swelling Inflammation Stabdata Stiffness walking velocity  0th Day. 7th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in following parameters between day 0day 8 day in CBC, LFT, RFT
 		 0 day 8 th day 
 
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   Phase 2 
Date of First Enrollment (India)   10/11/2025 
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="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   Effect of Gel Containing Plumbago Zeylanica in Mild to Moderate Knee Osteoarthritis A Single Armed Open Label Pilot Clinical Trial Objectives To evaluate the efficacy of Plumbago zeylanica gel as topical application in mild to moderate Knee Osteoarthritis in pain To assess the safety of Plumbago zeylanica gel as topical application in mild to moderate Knee Osteoarthritis 
Single centric Single Group clinical conditions having pain and inflammation with Pretest and Posttest design
30 patients with knee osteoarthritis meeting all inclusion/exclusion criteria will be included in the study
Trial medication Twice in a Day for a period of 7days Gel Containing Plumbago Zeylanica This will be applied at the site of pain 
Follow-up will be on 0th & 8th day
 
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