]>
IRCT20230628058606N1 IRCT 2023-08-07 Kerman University of Medical Sciences The effect of the Persian medicine product based on colchicum on knee osteoarthritis Investigating the effect of the Persian medicine product based on colchicum compared to placebo on pain and morning stiffness in patients with knee osteoarthritis: a triple-blind randomized clinical trial 2023-08-23 anticipated 70 Complete https://irct.ir/trial/70965 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are included in the study by block randomization in 35 blocks of size 2, Blinding description: Capsules containing herbal medicine and placebo are placed completely similar packages after matching in terms of shape, smell and color and the packages are coded and provided to the researcher. The study is triple blind. Patients, researchers, and data analysts are blinded to capsule contents and codes. The person who codes the drugs has no role in patient selection and interpretation of results until the end of the study. 3 Osteoarthritis. Intervention 1: Intervention group: 35 patients receiving capsules containing colchicum, ashwagandha and mustic gum twice a day for 42 days. Intervention 2: Control group: 35 patients receiving capsules containing corn starch twice a day for 42 days. 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 There is no further information
public Hossein Karegar-Borzi
Faculty of Persian Medicine; Kerman University of Medical Sciences; Haft-Bagh highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3133 6185 kbhossein@yahoo.com Kerman University of Medical Sciences scientific Hossein Karegar-Borzi
Faculty of Persian Medicine; Kerman University of Medical Sciences; Haft-Bagh highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3133 6185 kbhossein@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age of 45-75 years old Diagnosis of knee osteoarthritis based on the criteria of the American College of Rheumatology, which is confirmed by a rheumatology specialist. The presence of moderate knee pain within 24 hours based on linear-visual pain scale (VAS) between 3.5 and 7.5 cm. Completing the inform consent form 45 years 70 years Both Pregnancy or breastfeeding Lack of physical and mental ability to answer questions Occurrence of debilitating disease during treatment History of allergy to herbal medicines use of alcohol or drug abuse History of systemic diseases such as heart failure, kidney failure and uncontrolled blood pressure Routine use of oral analgesic (except 500 mg oral acetaminophen daily) Consuming nutritional and medicinal supplements on a regular and daily basis Intra-articular injection of corticosteroid drugs during the last six months M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: 35 patients receiving capsules containing colchicum, ashwagandha and mustic gum twice a day for 42 days Control group: 35 patients receiving capsules containing corn starch twice a day for 42 days Knee pain intensity. Timepoint: at the begining of intervention and 21 and 42 days after the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire, visual analogue scale (VAS) questionnaire. Morning stiffness of knee. Timepoint: at the begining of intervention and 21 and 42 days after the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Physical performance. Timepoint: at the begining of intervention and 21 and 42 days after the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Heel to thigh distance. Timepoint: at the begining of intervention and 21 and 42 days after the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Kerman University of Medical Sciences Approved 2023-05-01 Ethics committee of Kerman University of Medical Sciences Faculty of Persian medicine; Kerman university of medical sciences; Haft-Bagh highway Kerman Kerman Iran (Islamic Republic of)