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CTRI Number  CTRI/2023/09/057856 [Registered on: 19/09/2023] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the efficacy, safety and tolerability of Palmitoylethanolamide in subjects with symptoms of knee osteoarthritis. 
Scientific Title of Study   A multi-centre, double-blind, randomized, three-arm, interventional, parallel, placebo-controlled study to evaluate the efficacy, safety and tolerability of Palmitoylethanolamide in subjects with symptoms of knee osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AR022-23, 01, 30 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr U Lakshmi Mallikarjuna Vivek 
Designation  Trial Co-Ordinator/Medical Monitor 
Affiliation  ADVITY Research Private Ltd 
Address  ADVITY Research Private Ltd 3rd & 4th Floors, Archies Continental, P. No. 2A, 3, S. No. 1094 & 1095, Adj: Kukatpally Metro station, Kukatpally, Hyderabad 500072 Telangana, India

Hyderabad
TELANGANA
500072
India 
Phone  04069089999  
Fax    
Email  vivek.uppuluri@advityresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Penchala Kalyan Reddy Mule 
Designation  Director — Clinical Operations 
Affiliation  ADVITY Research Private Ltd 
Address  ADVITY Research Private Ltd 3rd & 4th Floors, Archies Continental, P. No. 2A, 3, S. No. 1094 & 1095, Adj: Kukatpally Metro station, Kukatpally, Hyderabad 500072 Telangana, India

Hyderabad
TELANGANA
500072
India 
Phone  04069089999  
Fax    
Email  kalyan.mule@advityresearch.com  
 
Details of Contact Person
Public Query  
Name  Penchala Kalyan Reddy Mule 
Designation  Director — Clinical Operations 
Affiliation  ADVITY Research Private Ltd 
Address  ADVITY Research Private Ltd 3rd & 4th Floors, Archies Continental, P. No. 2A, 3, S. No. 1094 & 1095, Adj: Kukatpally Metro station, Kukatpally, Hyderabad 500072 Telangana, India

Hyderabad
TELANGANA
500072
India 
Phone  04069089999  
Fax    
Email  kalyan.mule@advityresearch.com  
 
Source of Monetary or Material Support  
Bio-gen Extracts Private Limited 
 
Primary Sponsor  
Name  Bio-gen Extracts Private Limited 
Address  Bio-gen House, 254/1-9, 3rd Floor, 11th Main Road, 3rd Phase, Peenya Industrial Area, Bangalore 560 058, Karnataka, INDIA 
Type of Sponsor  Other [Nutraceutical Industry-India] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V V Satyanarayana E  Aware Gleneagles Global Hospitals  OPD, Room Number 11, Ground Floor, Division and Department of Orthopedics, LB Nagar, Hyderabad-500035
Hyderabad
TELANGANA 		 8332868579

sat_veera@yahoo.co.in 
Dr Ram Kumar Reddy  Mahatma Gandhi Memorial Hospital  Room Number 12&13,Ground Floor, Division and Department of Orthopedics, M G Road, Sherpura,Warangal-506002
Warangal
TELANGANA 		 9849255864

drramkumar.krcwgl@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Gleneagles Global Hospitals  Approved 
Kakatiya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 7||Osteopathic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Palmitoylethanolamide 150mg  150 mg orally to be administered twice daily for 12 weeks.  
Intervention  Palmitoylethanolamide 300mg  300 mg orally to be administered twice daily for 12 weeks. 
Comparator Agent  Placebo  Placebo orally to be administered twice daily for 12 weeks 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Males and females between 35 to 65 years of age (including both).
2.Subjects having pain associated to mild to moderate Knee Osteoarthritis in one or both Knees.
3.A pain intensity score of ≥ 4 as evaluated by the NRS (Numerical Rating Scale).
4.Ability to communicate effectively.
5.Voluntary participation.
6.Self-reported average knee pain over the past month at least 4 out of 10 on a 0-10 NRS (Numerical rating scale).
7.No anticipated surgical procedures.
8.Assessed as otherwise healthy (except for Knee Osteoarthritis), based on a pre-study examination including medical history, physical examination, and clinical laboratory investigations. The examination will be performed by a physician.
9.Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements. 
 
ExclusionCriteria 
Details  1.Known history of hypersensitivity to PEA or herbal extracts or dietary supplements.
2.Having a pain intensity score <4 on NRS.
3.Subjects diagnosed to have arthritis other than Knee osteoarthritis.
4.BMI >35kg/m2
5.Knee injury in the past 06 months.
6.Knee surgery in the past 12 months or total knee replacement.
7.Enrolled in other knee osteoarthritis rehabilitation programs or clinical trials.
8.Any condition likely to interfere with normal gastro-intestinal absorption of PEA.
9.History or presence of diseases attributable to psychiatric disorders and subjects undergoing, or scheduled to undergo, physiotherapy, radiotherapy, or chemotherapeutic treatment.
10.Presence of systemic diseases like hyper- cholesterolemia, renal disorder, liver disorder, and other debilitating diseases.
11.Oral or intra-articular glucocorticoid use in the prior 3 months; intra-articular hyaluronate use in the prior 6 months.
12.Allergy to oat, coconut, citrus, olive, or sunflower oils, or maltodextrin.
13.On-going treatment with herbals drugs.
14.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
15.Females who are pregnant, lactating or nursing.
16.Females who intend to become pregnant during the study.
17.Have a family history (more than one first degree relative) of multiple thrombotic events (more than one per person) or a personal history of any venous or arteria thrombotic event including deep vein thrombosis, stroke, myocardial infarction, pulmonary embolus, and peripheral arterial thromboembolic events or abnormal ECG which may impact the subject’s safety as per Investigator’s opinion.
18.Positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti- hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody screen, based on the current medical data of the subject.
19.History of active or latent tuberculosis.
20.Abnormal hepatic function [alanine aminotransferase (ALT)/aspartate aminotransferase (AST) or bilirubin > 2 x upper limit of normal] at the time of the Screening Visit.
21.Abnormal renal function [Blood Urea Nitrogen (BUN) or creatinine >1.25 x upper limit of normal] at the time of the Screening Visit.
22.Clinically significant out-of-range values on hematology panel, at the discretion of the investigator.
23.Any other relevant abnormalities in the routine laboratory tests.
24.Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study.
25.History of substance abuse or alcohol abuse.
26.History of blood donation within 3 months before screening.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in WOMAC total score from baseline to end of the study duration.  From Baseline to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in inflammatory biomarkers (hs-CRP) from baseline to end of the treatment i.e., 12 weeks.
Difference in the knee pain intensity measured by numerical rating scale from baseline to week 4, week 8 & week 12.
Improvement in Quality-of-Life (PROMIS-29) measured from baseline to week 4, week 8 & week 12.
Reduction in WOMAC total score from baseline to week 4 and week 8 as measured with WOMAC scale.
Change in the usage of rescue medication in the study subjects from week 1 to week 12. 		 from baseline to 12 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 molecule, researched for its unique and wide range of health benefits for eighty years, is now receiving attention because of its crucial role in the endocannabinoid system (ECS). The ECS is a communication network that maintains cellular homeostasis especially when tissues are damaged, inflamed or injured. PEA is an endocannabinoid produced locally by the cells, following any injury, physical stress or pain. By inhibiting the activation of mast cells that cause additional inflammation (such as the release of histamine), PEA acts as a potent anti-inflammatory agent. This unique molecule has other direct and indirect mechanisms of action; it enhances the action of other endocannabinoids through its “entourage effect” and the action on numerous novel cellular receptors including PPAR. It has been clinically demonstrated that the PEA molecule has the capacity to relieve pain in osteoarthritis of the knee as well as to reduce symptoms of low back pain, Rheumatoid Arthritis, Neuropathic and inflammatory pain, Neurodegenerative conditions, Ischaemic stroke and brain injury, Topical use for dermatitis, use for allergies (preventing mast cell de-granulation) and is well tolerated.

The aim of Clinical trial is to evaluate the efficacy, safety and tolerability of Palmitoylethanolamide in subjects with symptoms of knee osteoarthritis.
 
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