Studying the effects of Boswellia serrata, Zingiber officinale and Elaeagnus angustifolia mixture on pain, physical activity, and joint stiffness in patients with knee osteoarthritis: A randomized, placebo-controlled clinical trial

Studying the effects of Boswellia serrata, Zingiber officinale and Elaeagnus angustifolia mixture on pain, physical activity, and joint stiffness in patients with knee osteoarthritis

This clinical trial study will be conducted in a double-blind phase 2-3 on 60 patients with knee osteoarthritis. Patients are randomly divided into two parallel groups. After completing the relevant questionnaires, patients will be given a herbal medicine bottle containing 60 herbal medicine capsules or placebo and its code (A or B) will be recorded in the patient's medical records.

Patients with knee osteoarthritis referring to Baghiatallah Hospital according to inclusion criteria randomly divided to herbal medicine or placebo groups. Except main investigator, non of the medical stuff, patients, data collector and who evaluate the outcome, are unaware of the medication type.

Inclusion criteria: Male or female patients aged 40 to 80 years who have osteoarthritis of the knee 1 or 2 according to the criteria of the American College of Rheumatology. Exclusion criteria: Secondary osteoarthritis; arthroscopy; surgery; injection into the target knee joint within the past 6 months; any serious systemic disease or chronic inflammatory disease; blood clotting disorders; use of anticoagulants such as warfarin and heparin; use of antiplatelet drugs such as aspirin and thrombolytic drugs

Herbal Medicine group: Patients take one capsule of 500 mg of herbal medicine orally every 12 hours after meals for 2 months. Placebo group: Patients take one capsule of 500 mg of placebo orally every 12 hours after meals for 2 months.

Joint pain using Visual Analog Scale questionnaire and joint stiffness and physical activity using Western Ontario and McMaster Universities Arthritis Index questionnaire

For randomization, the block randomization method will be used. By visiting the website www.sealedenvelope.com and selecting the 'Randomization' tab, the 'Make a list' option will be clicked. After specifying the number of intervention groups, the sample size, and the block size (which is set to 4 in this study), a randomized list containing specific patient codes will be generated and used for the randomization process. A randomly generated list will be used to create a series of sequentially numbered, sealed envelopes. Each envelope will be marked with a unique patient code, and inside will be a card indicating the assigned intervention group. Following the enrollment of each eligible patient, the envelope corresponding to the next sequential code will be opened by the researcher. The patient will then be assigned to their intervention group based on the card contained within the envelope.

Letters A or B are labeled on herbal medicine or placebo cans. Other specifications on the labels are completely identical. Physician, nurse, patient, data collector and those who evaluate the outcome, are unaware of the nature and meaning of the letters A or B on the labels. Only the main investigator knows the nature of the labels. Patients are aware that they are either in the drug or in the placebo groups, but they are not aware of the type of group they are in.