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IRCT20130313012810N103 IRCT 2026-06-11 Tabriz University of Medical Sciences Evaluation of a topical omega-3 gel for the reduction of pain and improvement of knee osteoarthritis Evaluation of the effects of a topical gel based on Nanostructured Lipid Carriers (NLC) loaded with Omega-3 compared to placebo on knee pain and inflammation in patients with knee osteoarthritis 2026-06-11 anticipated 30 Complete https://irct.ir/trial/90361 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed at the patient level to determine the treatment sequence for the knees (left vs. right) using a permuted block randomization method (with block sizes of 2 and 4). Each patient will be allocated to one of two sequences: Sequence A (Left knee: Omega-3 NLC gel; Right knee: Placebo gel) or Sequence B (Left knee: Placebo gel; Right knee: Omega-3 NLC gel). The unit of randomization is the individual patient. The allocation sequence will be generated using statistical software by an independent statistician who is not involved in clinical assessments. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be utilized. Upon enrollment of an eligible patient, the corresponding envelope will be opened in numerical order to determine which knee receives the active intervention and which receives the placebo, Blinding description: The investigational products (Omega-3 NLC gel and placebo gel) will be identical in all physical characteristics, including color, odor, consistency, and packaging in identical tubes. The formulations will be prepared and labeled with unique codes (e.g., Gel A and Gel B) by the principal investigator (the formulation pharmacist), who is aware of the assignments but will have no role in the clinical enrollment, management, or evaluation of the patients. The participants (patients) will be fully blinded to which knee receives the active or placebo gel throughout the study. The outcome assessor (the clinician responsible for measuring and recording the VAS pain scores at baseline and at the end of the study) will also be completely blinded to the identity of the gels. Furthermore, the compiled data will be provided to the data analyst (statistician) in a coded format, and unblinding of the treatment codes will only occur after the statistical analysis has been fully completed. 2 Knee Osteoarthritis. Intervention 1: Intervention group: 30 patients with bilateral knee osteoarthritis will topically apply an omega 3 nanostructured lipid carrier gel formulation twice daily (morning and evening) to the randomly assigned knee for a duration of one month (30 days). For each application, 1 gram of the gel will be applied topically to the affected knee areas. The formulation is prepared under standard laboratory conditions at the Drug Applied Research Center, Tabriz University of Medical Sciences, and packaged into identically coded tubes. The chemical composition of the gel consists of a lipid phase (omega 3 fatty acids, Precirol ATO 5, and gamma oryzanol), an aqueous surfactant phase (Tween 80 and Poloxamer), and a gel base matrix (Carbopol 940, triethanolamine, and distilled water). All participants will receive standardized education regarding proper topical application techniques and daily adherence protocols before initiating the trial. Intervention 2: Control group: The same patients will topically apply the placebo gel formulation twice daily (morning and evening) to the contralateral knee (opposite to the intervention knee) for a duration of one month (30 days). For each application, 1 gram of the gel will be applied topically to the affected knee areas. The formulation is prepared under standard laboratory conditions at the Drug Applied Research Center, Tabriz University of Medical Sciences, and packaged into coded tubes identical to the active gel. The chemical composition of the placebo gel is identical to the intervention gel except that Miglyol oil replaces the omega 3 fatty acids in the lipid phase (consisting of Miglyol, Precirol ATO 5, and gamma oryzanol)؛ while the aqueous surfactant phase (Tween 80 and Poloxamer) and the gel base matrix (Carbopol 940, triethanolamine, and distilled water) remain the exact same. All participants will receive standardized education regarding proper topical application techniques and daily adherence protocols before initiating the trial. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is University approval is required
public Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age greater than or equal to 50 years Confirmed diagnosis of knee osteoarthritis based on the American College of Rheumatology (ACR) clinical criteria Baseline pain score between 2 and 7 on the Visual Analog Scale (VAS) despite receiving standard care Radiographic evidence of knee osteoarthritis with Kellgren-Lawrence grade 1 to 3 Physical ability to apply the topical gel twice daily and attend all follow-up sessions Willingness to provide written informed consent and comply with study protocols 50 years no limit Both Presence of severe knee osteoarthritis with Kellgren-Lawrence grade 4 History of hypersensitivity or intolerance to fish oil, omega-3, or any component of the gel formulation Severe systemic comorbidities including uncontrolled diabetes (HbA1c greater than 9 percent), recent cardiovascular events, renal or hepatic impairment, or active malignancy Use of systemic anti-inflammatory drugs (NSAIDs, corticosteroids, biologics) or omega-3 supplements within the past 4 weeks Active skin diseases, open wounds, severe inflammation, redness, or extreme local warmth at the knee site preventing topical application Pregnancy, lactation, or planning to become pregnant during the study period Inability to ambulate without assistance or inability to complete assessments due to severe cognitive impairment History of intra-articular knee injections within the past 3 months Receipt of physical therapy or hydrotherapy for the knee within the past 3 months Presence of lower extremity radiculopathy, neuropathy, or other neurogenic conditions such as polio ​Concomitant pain in the hip or ankle joints that confounds the assessment of knee pain Body Mass Index (BMI) greater than 30 kilograms per square meter Secondary knee osteoarthritis resulting from previous bone fractures or trauma Requirement for concurrent treatment with regular systemic NSAIDs (except for a maximum of 10 tablets of 500 mg acetaminophen without codeine per month) Participation in any other clinical trial within the past 30 days M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: 30 patients with bilateral knee osteoarthritis will topically apply an omega 3 nanostructured lipid carrier gel formulation twice daily (morning and evening) to the randomly assigned knee for a duration of one month (30 days). For each application, 1 gram of the gel will be applied topically to the affected knee areas. The formulation is prepared under standard laboratory conditions at the Drug Applied Research Center, Tabriz University of Medical Sciences, and packaged into identically coded tubes. The chemical composition of the gel consists of a lipid phase (omega 3 fatty acids, Precirol ATO 5, and gamma oryzanol), an aqueous surfactant phase (Tween 80 and Poloxamer), and a gel base matrix (Carbopol 940, triethanolamine, and distilled water). All participants will receive standardized education regarding proper topical application techniques and daily adherence protocols before initiating the trial. Control group: The same patients will topically apply the placebo gel formulation twice daily (morning and evening) to the contralateral knee (opposite to the intervention knee) for a duration of one month (30 days). For each application, 1 gram of the gel will be applied topically to the affected knee areas. The formulation is prepared under standard laboratory conditions at the Drug Applied Research Center, Tabriz University of Medical Sciences, and packaged into coded tubes identical to the active gel. The chemical composition of the placebo gel is identical to the intervention gel except that Miglyol oil replaces the omega 3 fatty acids in the lipid phase (consisting of Miglyol, Precirol ATO 5, and gamma oryzanol)؛ while the aqueous surfactant phase (Tween 80 and Poloxamer) and the gel base matrix (Carbopol 940, triethanolamine, and distilled water) remain the exact same. All participants will receive standardized education regarding proper topical application techniques and daily adherence protocols before initiating the trial. The severity of knee joint pain intensity in patients with mild to moderate osteoarthritis. Timepoint: At baseline before the intervention and four weeks after the start of the treatment. Method of measurement: Using the zero to ten centimeter visual analog scale questionnaire. The severity of local inflammation and swelling in the knee joint area. Timepoint: At baseline before the intervention and four weeks after the start of the treatment. Method of measurement: Through local physical examination and knee joint palpation by an orthopedist specialist. The requirement and consumption amount of rescue analgesic medication by the patient during the study period. Timepoint: At baseline, two and four weeks after the start of the trial. Method of measurement: By counting the number of consumed acetaminophen tablets recorded in the patient daily diary log. Tabriz University of Medical Sciences Approved 2026-05-24 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Daneshgah Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)