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IRCT20161022030424N10 IRCT 2023-12-29 Tabriz University of Medical Sciences The effect of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet in patients with knee osteoarthritis The effect of oral administration and topical application of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet on anthropometric indices, pain, physical function, and serum indices of oxidative stress in patients with knee osteoarthritis 2024-04-18 anticipated 88 Complete https://irct.ir/trial/74425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: A block randomization method will be used to allocate participants to the groups with a 1:1:1:1 allocation using random allocation software (RAS) with block sizes of 4 and 8. Similarly sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package, Blinding description: Flaxseed and placebo food supplements are prepared and presented by Barij Essan Pharmaceutical Company, Kashan, Iran, and there will be no difference in color, shape, or taste between them. Liquid paraffin is packaged in containers similar to Flaxseed oil containers. Blocking and random allocation of the investigated subjects is done by a statistician outside the research team of the project. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study. 3 Knee osteoarthritis. Intervention 1: The first intervention group: was given one flax seed oil (Barij Essential Oil Company, Kashan, Iran) three times a day for 8 weeks, plus topical flax seed oil (Barij Essential Oil Company, Kashan, Iran) 20 drops every 8 hours to rub on the knees along with a low-calorie diet. Intervention 2: The second intervention group: for 8 weeks, they received a placebo of flaxseed oil and topical flaxseed oil (Barij Essan Pharmaceutical Company, Kashan, Iran) three times a day, 20 drops every 8 hours to rub on the knees along with a low-calorie diet. Intervention 3: The third intervention group: For 8 weeks, they will receive one flaxseed oil three times a day (Barij Essence Pharmaceutical Company, Kashan, Iran) plus topical paraffin oil as a placebo to rub on the knees along with a low-calorie diet. Intervention 4: Control group: for 8 weeks, they received a placebo of flaxseed oil and topical paraffin oil as a placebo to rub on the knees three times a day along with a low-calorie diet. 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 There is no further information.
public Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995749 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda Dolatkhah
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of knee osteoarthritis by a physical medicine specialist (mild, moderate) based on the diagnostic criteria of the American College of Rheumatology and the radiological evaluation of knee osteoarthritis by Clairgen Lawrence Overweight and obese people based on body mass index of 25-40 weight per square meter Not taking anticoagulants Absence of knee joint replacement surgery Absence of fractures involving the surface of the knee joint Absence of skin diseases in the knee area Absence of other systemic rheumatic diseases or RA, neuropathy, sensory disturbances due to drug, sedative or tobacco use 40 years no limit Both Treatment with oral or intra articular corticosteroids in the past 3 months M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo The first intervention group: was given one flax seed oil (Barij Essential Oil Company, Kashan, Iran) three times a day for 8 weeks, plus topical flax seed oil (Barij Essential Oil Company, Kashan, Iran) 20 drops every 8 hours to rub on the knees along with a low-calorie diet. The second intervention group: for 8 weeks, they received a placebo of flaxseed oil and topical flaxseed oil (Barij Essan Pharmaceutical Company, Kashan, Iran) three times a day, 20 drops every 8 hours to rub on the knees along with a low-calorie diet. The third intervention group: For 8 weeks, they will receive one flaxseed oil three times a day (Barij Essence Pharmaceutical Company, Kashan, Iran) plus topical paraffin oil as a placebo to rub on the knees along with a low-calorie diet. Control group: for 8 weeks, they received a placebo of flaxseed oil and topical paraffin oil as a placebo to rub on the knees three times a day along with a low-calorie diet. Physical performance. Timepoint: Evaluation of physical performance at baseline (before intervention) and 8 weeks after starting the oral and topical supplement of flaxseed oil. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Pain intensity. Timepoint: Measurement of the pain intensity at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Visual Analogue Scale. Anthropometric indices. Timepoint: Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Seca digital scale. Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Biochemical analysis. Tabriz University of Medical Sciences Approved 2023-09-25 Research ethics committee of Tabriz University of Medical Sciences Emam Reza hospital, Golgasht str., Azadi ave., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)