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IRCT20140804018677N8 IRCT 2021-03-02 Shahid Beheshti University of Medical Sciences Effects of tumeric and Serrapeptase capsule on reducing pain and improve range of motion in patients with osteoarthritis of the knee Effects of tumeric (Curcuma longa) and Serrapeptase supplementation on reducing pain and improve range of motion in patients with osteoarthritis of the knee ( a double blind randomized controlled trial) 2021-02-28 anticipated 80 Complete https://irct.ir/trial/54200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling, Blinding description: It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code at the time of sampling. The following groups of people involved in the trial: participants, Research team including principle investigator, data collectors, and outcome assessors will be blind. 3 knee osteoarthritis. Intervention 1: Intervention group: Serapeptase (30 mg)/turmeric (20 mg) per cap- for 10 days- rayan pharmed company. Intervention 2: Control group: placebo containing maltodextrine-for 10 days- rayan pharmed company. Yes - There is a plan to make this available What will be shared: All data would be available to public When: starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: sending email Comments:
public Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razeghi Jahromi
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 1981619537 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age>45y and having knee osteoarthritis according to American College of Rheumatology diagnostic criteria Knee pain with at least three of the followings: age>50, morning stiffness<30 min, crepitation, bone tenderness at knee, knee bone enlargement, warmness or pain in addition to osteophyte according to radiography Grade 2 or 3 of osteoarthritis according to Kellgren and Lawrence system Pain intensity between 5-8 at baseline according to Visual analog scale-VAS Able to walk independently 45 years no limit Both not having joint arteritis, orthopedic or severe cardiovascular diseases intra-articular injection of corticosteroids in past 3 months, as well as gel, and Platelet-rich plasma (PRP) in past year Severe pain or allergic reaction during intervention that need for Nonsteroidal anti-inflammatory drugs (NSAIDs) unable to complete the study BMI>35 M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: Serapeptase (30 mg)/turmeric (20 mg) per cap- for 10 days- rayan pharmed company Control group: placebo containing maltodextrine-for 10 days- rayan pharmed company Pain. Timepoint: Baseline and at the end of the study. Method of measurement: VAS (visual analog scale). Range of Motion and stiffness. Timepoint: Baseline and at the end of the study. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC). Shahid Beheshti University of Medical Sciences Approved 2021-02-08 Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)