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IRCT20220531055045N1 IRCT 2022-06-11 Shiraz University of Medical Sciences Curcumin organogel for osteoarthritis treatment The effect of a Curcumin organogel on knee osteoarthritis: a randomized placebo trial 2022-06-06 anticipated 70 Complete https://irct.ir/trial/63936 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: not included, Randomization description: Computer-generated randomization is employed, and the subjects are assigned with a three-digit randomization code number, Blinding description: After definite diagnosis of osteoarthritis and agreement to participate in the study, the patients will be interviewed and practically trained on how to use the Curcumin OGs. The patients in the intervention group will receive Curcumin OGs and the patients in the placebo group will receive curcumin-free placebo gels. However, both groups will receive similar educations and have no contact with each other. The clinical observer and the outcome assessor will also have no knowledge of the type of intervention during the study. 3 Osteoarthritis. Intervention 1: Intervention group: Applying Curcumin OG 2% twice a day for 8 weeks on the knee area. Intervention 2: Control group: Applying Curcumin-free OG, twice a day, up to 8 weeks, on the knee area. Yes - There is a plan to make this available What will be shared: Patients' information, Methodology and Results. When: As soon as the results are provided. To whom: People working in academic institutions or people working in pharmaceutical industries. Conditions: Statistical and scientific analyses with respecting to intellectual rights Where to obtain: Dr. Gholamhossein Yousefi using the phone 09123956292 How to obtain: Contact with investigators and official request expressing the reasons and the how of using data. Comments: Any usage of information is solely permitted via official channels and by informing and citing to the investigators.
public Gholamhossein Yousefi
Department of pharmaceutics, school of pharmacy, karafarin street, Shiraz Town, Iran
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4127 ghyousefi@sums.ac.ir Shiraz University of Medical Sciences scientific Gholamhossein Yousefi
Shiraz
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 5305 Ghyousefi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Having symptom of pain in joint Osteoarthritis (at Knee), stiffness, difficulty in flexion and extension, swelling for more than 3 months prior to the study Being free of any systemic or dermatological diseases Willing to refrain from using any lotion, gel, balm, moisturizer, cleanser, cosmetic or cream on the treatment areas during the treatment period Being able to give written informed consent in a manner approved by the Institutional Ethics Committee and complying with the requirements of the study Willing to avoid participation in any other interventional clinical trial during current study No known allergy to Curcumin and plants of the ginger family 50 years 70 years Both Showing a systemic or local allergic reaction to Curcumin organogel Discontinuation of the treatment before end of intervention, or stopping it for at least three consecutive days A decision to withdraw from the study Death Hospitalization Moving to another city M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: Applying Curcumin OG 2% twice a day for 8 weeks on the knee area. Control group: Applying Curcumin-free OG, twice a day, up to 8 weeks, on the knee area. Pain, Stiffness, Difficulty in knee movement. Timepoint: Before, 1, 2, 4 and 8 weeks after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index. Personal Approved 2022-04-30 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)