A randomized, double blind, placebo controlled comparative study to assess the efficacy and safety of Gogo Pain Relief & MSM (M) oil in treatment of osteoarthritis (OA) of the knee

Gods Own Store LLP0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Participants must be adults, aged at least 35 to 80 yrs old with radiographically established OA.
•2.At screening, subjects must complete questionnaires that would provide investigators with information on their medical and OA history and demographics. Pain level in the last week will be evaluated using the Visual Analog Scale (VAS) and functionality in activities of daily living with the Western Ontario and McMaster Universities Osteoarthritis Index.
•3.Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
•4.Subjects should be having a pre-randomization score of 40 to 90 on the Western Ontario and McMaster Universities Osteoarthritis Index.
•5.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
•6.Participants must be willing to apply the test product and return for assessment visits for evaluation.
•7.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications that has not been recommended by the study physician.

•1.Participants with rheumatoid arthritis; fibromyalgia; recurrent or active pseudogout, cancer, or other serious medical conditions
•2.Single or married subjects who are pregnant or have borne children in past one year.
•3.Participants with a history of signs or history of kidney or liver failure OR asthma requiring use of corticosteroids OR use of oral corticosteroids within the past 4 weeks
•4.Participants with a history of intra-articular knee depo corticosteroids within the previous 3 months, or intra-articular hyaluronate within the previous 6 months.
•5.Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome such as arthroscopy of the knee within the previous year; significant injury to the knee within the previous 6 months; or a rash or open wound over the knee.
•6Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
•7.Participant with known allergies to the main components of the test product or placebo.
•8.Participation in another clinical trial or taking an investigational product in the past three months
•9.Any participant who is not able to give informed consent.

发起方

Gods Own Store LLP