To evaluate the efficacy, safety and tolerability of Palmitoylethanolamide in subjects with symptoms of kneeosteoarthritis.
- Conditions
- Health Condition 1: 7- Osteopathic
- Registration Number
- CTRI/2023/09/057856
- Lead Sponsor
- Bio-gen Extracts Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in WOMAC total score from baseline to end of the study duration.Timepoint: From Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Change in inflammatory biomarkers (hs-CRP) from baseline to end of the treatment i.e., 12 weeks. <br/ ><br>Difference in the knee pain intensity measured by numerical rating scale from baseline to week 4, week 8 & week 12. <br/ ><br>Improvement in Quality-of-Life (PROMIS-29) measured from baseline to week 4, week 8 & week 12. <br/ ><br>Reduction in WOMAC total score from baseline to week 4 and week 8 as measured with WOMAC scale. <br/ ><br>Change in the usage of rescue medication in the study subjects from week 1 to week 12.Timepoint: from baseline to 12 weeks