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IRCT20161022030424N4 IRCT 2019-09-02 Tabriz University of Medical Sciences Probiotic saccharomyces boulardi in knee osteoarthritis The effect of probiotic saccharomyces boulardi on anthropometric indecies, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese patients with knee osteoarthritis 2019-09-23 anticipated 70 Complete https://irct.ir/trial/41506 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with block sizes of four and eight using RASS software and the allocation ratio of 1:1. Randomization and allocation concealment will be carried out for both the researchers and participants, by a trained staff at the research center, Blinding description: Main investigators, caregivers, outcome assessors, data analyser and the participants will be all masked to treatment assignment throughout the study. Since the supplements and placebo capsules have similar packaging, patients and researchers will be unaware of the content of the package until the end of study. 3 Knee osteoarthritis. Intervention 1: Intervention group: The intervention group will take BioDigest capsules once daily for 12 weeks. Each capsule contains 250 mg of SB (1010 CFU) plus a lactose filler and a magnesium stearate lubricant. The intervention capsules will be produced and packed by Takgene Pharmaceutical Company, Tehran, Iran. Intervention 2: Control group: The control group will take placebo capsules once daily for 12 weeks. In terms of shape, size, taste, smell, and other exfoliation characteristics, they are quite similar to the Biodigest capsules except that they do not contain any microorganisms. The placebo capsules will also be produced and packed by Takgene Pharmaceutical Company, Tehran, Iran. 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 No more information.
public 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 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) Patients diagnosed with knee osteoarthritis according to the diagnostic criteria of American College of Rheumatology Being 40 years of age or older Chronic knee pain for the last 3 months Radiologic confirmation of knee osteoarthritis (Kellgren–Lawrence grade II or III ) Body mass index in the range of 25 to 40 kg/m2 40 years no limit Both Previous knee surgery Rheumatoid arthritis Metabolic disorder (such as diabetes and cancer) Liver or kidney failure Use of corticosteroids and/or intra-articular injections during the preceding 3 months Use of fish oils and glucosamine Participation in a weight loss program in the preceding 6 months Unable to express their pain (such as those with any mental condition) M19.9 Osteoarthritis, unspecified site Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will take BioDigest capsules once daily for 12 weeks. Each capsule contains 250 mg of SB (1010 CFU) plus a lactose filler and a magnesium stearate lubricant. The intervention capsules will be produced and packed by Takgene Pharmaceutical Company, Tehran, Iran. Control group: The control group will take placebo capsules once daily for 12 weeks. In terms of shape, size, taste, smell, and other exfoliation characteristics, they are quite similar to the Biodigest capsules except that they do not contain any microorganisms. The placebo capsules will also be produced and packed by Takgene Pharmaceutical Company, Tehran, Iran. Weight. Timepoint: Weight measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Seca 813 bt digital scale. Functional status. Timepoint: Functional status evaluation at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Western Ontario and McMaster (WOMAC) Index. Pain intensity. Timepoint: Pain intensity measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Visual Analogue Scale. Quality of life. Timepoint: Quality of life evaluation at baseline (before intervention) and 12 weeks after intervention. Method of measurement: 36-Item Short Form Survey (SF-36). Inflammatory indices. Timepoint: Inflammatory indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Oxidative stress indices. Timepoint: Oxidative stress indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods. Tabriz University of Medical Sciences Approved 2019-07-29 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)