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CTRI Number  CTRI/2026/04/107894 [Registered on: 08/04/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study on the Effect of a Cannabis-Based Herbal Formulation for Reducing Inflammation in Osteoarthritis Patients 
Scientific Title of Study   A SINGLE-ARM, OPEN-LABEL INTERVENTIONAL STUDY TO EVALUATE THE ANTI-INFLAMMATORY EFFECT OF A CANNABIS BASED FORMULATION WSR TO OSTEOARTHRITIS. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIOA/PCAH/CT/2026 Version 1 Date: 11/01/2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravishankar A G 
Designation  Professor and HOD 
Affiliation  Prasanna College of Ayurveda and Hospital 
Address  Department of Shalyatantra, Prasanna Ayurveda Medical College, Laila Belthangady

Dakshina Kannada
KARNATAKA
574214
India 
Phone  9448260242  
Fax    
Email  agravishankar75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravishankar A G 
Designation  Professor and HOD 
Affiliation  Prasanna College of Ayurveda and Hospital 
Address  Department of Shalyatantra, Prasanna Ayurveda Medical College, Laila Belthangady

Dakshina Kannada
KARNATAKA
574214
India 
Phone  9448260242  
Fax    
Email  agravishankar75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh T S 
Designation  Professor and HOD 
Affiliation  Prasanna College of Ayurveda and Hospital 
Address  Department of Dravyaguna, Prasanna Ayurveda Medical College, Laila Belthangady

Dakshina Kannada
KARNATAKA
574214
India 
Phone  9448160784  
Fax    
Email  dtsmv2002@gmail.com  
 
Source of Monetary or Material Support  
Hempceuticals LLP 
 
Primary Sponsor  
Name  Hempceuticals LLP 
Address  Q6, KSSIDC INDUSTRIES ESTATE JIGNI II PHASE, ANEKAL TQ 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Epistemex innovations Private Limited  304 Janani Apartments Nagarakatte Moodbidri 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh T S  PRASANNA COLLEGE OF AYURVEDA HOSPITAL  Department of Shalya Tantra Ujire Belthangady Road, Laila, Belthangady
Dakshina Kannada
KARNATAKA 		 9448160784

dtsmv2002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PCAH Institutional Clinical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: CFD-Cannoflam, Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 20(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water after 5 minutes of administration), Additional Information: -
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Male or female subjects who are suffering from Osteo Arthritis.
Subjects willing to give a written informed consent and agree to come for a regular follow-up visit.
Subjects willing to abide by and comply with the study protocol.
Subjects who have not participated in a similar investigation in the past three months.
Subjects who have not taken any analgesics or NSAIDs, etc for a period of 15 days before the start of the trial and are willing to avoid them till the end of the trial. 
 
ExclusionCriteria 
Details  Subjects who have undergone invasive treatments like surgery within 3 months before screening into the study.
Subjects having any active disease that may interfere with the study.
Any history of underlying uncontrolled medical illness, including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness.
A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products.
Subjects who had been part of any other clinical study within 3 months before screening into the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Anti-Inflammatory Effect in Osteo-Arthritis Patients treated with Cannabis based Polyherbal formulation  Baseline, 30 Days (After Treatment) and 90 Days (After follow-up) 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Pain Reduction.  Baseline, Day 7, Day 15, Day 21, Day 30 (After Treatment), Day 60 & Day 90 (After Follow-up) 
Evaluation of Quality of Life  Baseline, Day 7, Day 15, Day 21, Day 30 (After Treatment), Day 60 & Day 90 (After Follow-up) 
Evaluation of ESR & CRP  Baseline & Day 30. 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   10/04/2026 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Inflammation is a fundamental pathological process underlying several acute and chronic clinical conditions, including pain syndromes, musculoskeletal disorders, gynaecological conditions, metabolic disorders, and sleep disturbances. Persistent low-grade inflammation is often reflected by elevated inflammatory biomarkers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and pro-inflammatory cytokines.

Cannabis and certain herbal constituents possess documented anti-inflammatory, analgesic, and immunomodulatory properties, mediated through modulation of the endocannabinoid system, cyclooxygenase pathways, and cytokine signalling. Polyherbal formulations incorporating cannabis are traditionally used in integrative medicine systems for inflammatory conditions; however, systematic clinical evidence supporting their anti-inflammatory effects remains limited.

This study is designed as a single-arm, open-label, exploratory clinical trial to generate preliminary evidence on the anti-inflammatory potential, clinical response, and safety profile of a cannabis-based formulation using objective inflammatory markers and clinical assessments on patients with Osteo Arthritis. The present study will enable us to observe the efficacy of a Cannabis based polyherbal formulation in joint pain management on those patients who are suffering from Osteoarthritis.

 
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