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)

Determining the effect of oral turmeric (Domestica Val. Curcuma) and Serrapeptase in reducing painو improving range of motion and reducing joint stifness in patients with knee osteoarthritis compared to controls

80 participants (no=40 per group) are randomly assigned to intervention and placebo group using random digit table

This double blinded study will be performed in Fayaz Bakhsh Hospital. At base line and after 10 days of intervention with supplement/placebo, pain intensity using VAS and range of motion & stiffness using Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be recorded.

Inclusion criteria: 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 VAS (Visual Analog Scale) Able to walk independently Exclusion criteria: 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 NSAIDs unable to complete the study Body mass index>35

Patients will receive serapeptase and turmeric capsule or placebo BD for 10 days. Each capsule contains 30 mg serapeptase and 20 mg turmeric or maltodextrine in placebo group.

Main output: effect of turmeric/serapeltase on pain, range of motion and stiffness of patients with knee osteoarthritis

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

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.

All data would be available to public

starting 6 months after publication

To all

No other critaria

Email to soodehrazeghi@gmail.com

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