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IRCT20240406061427N1 IRCT 2024-07-15 Shahre-kord University of Medical Sciences Effect of Terminalia chebula gel in reducing the pain of patients with knee arthritis Effect of Terminalia chebula gel in reducing the pain of patients with knee osteoarthritis: triple-blind randomized clinical trial 2024-07-22 anticipated 78 Complete https://irct.ir/trial/76472 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The random unit The random unit will be an individual participant. Each participant is randomly assigned to one of the two groups of intervention (Black Haliley gel) or control group (placebo gel). Layered randomization In layered randomization, participants are layered based on key variables such as age, gender and primary pain in order to ensure balanced distribution among therapeutic groups. For example, layers are defined by age groups (less than 5 years, 2 years and older), gender (male, female) and primary pain (low, medium, severe). The random sequence of random numbers generated by the computer will be used. This sequence is produced using statistical software such as SPSS, R or SAS to ensure randomness in randomization if the individual is observed, the individual is entered into the intervention group and if the number is even, the control group is entered into the control group. Allocation Concealment: The study coordinator delivers the relevant gel to the participant after completing the initial evaluation of the participant and confirming his or her qualification to participate in the study, and reviewing the allocated treatment group (intervention/ control), Blinding description: The samples prepared by the pharmacognosist colleague are packed in tubes marked with A, B and C so that the researcher, the patient and the statistician of the project are not aware of the content of the three types of tubes A, B and C. 3 knee osteoarthritis. Intervention 1: The first intervention group: 26 patients with knee osteoarthritis are selected. The first intervention group consumes 5% Halileh black topical gel 3 times a day locally on the knee. Participants will be informed that the type of treatment they received will not be known to avoid bias. They are also encouraged not to guess which treatment they received during the study. Intervention 2: The second intervention group: 26 patients with knee osteoarthritis are selected. The second intervention group uses diclofenac 1% topical gel 3 times a day. Intervention 3: Control group: 26 patients with knee osteoarthritis are selected. The control group consumes placebo gel 3 times a day. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions. Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address navid.1999@yahoo.com or the contact number 00989103259963. How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Navid Oboudiat
Molavi St.
Shahrekord Iran (Islamic Republic of) 8179947161 +98 31 3650 5792 navid.1999@yahoo.com Shahre-kord University of Medical Sciences scientific Navid Oboudiat
Molavi St.
Shahrekord Iran (Islamic Republic of) 8179947161 +98 31 3650 5792 navid.1999@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) All patients with a definite diagnosis of osteoarthritis based on diagnostic criteria by a specialist doctor Age range between 45 and 75 years 45 years 75 years Both The presence of simultaneous severe diseases such as metabolic and gastrointestinal diseases Severe infection Pregnancy and breastfeeding and abnormal liver tests History of old fracture or knee surgery Rheumatoid arthritis and seronegative and seropositive arthropathy History of intra-articular injection in the last 6 weeks M19.9 Osteoarthritis, unspecified site Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: 26 patients with knee osteoarthritis are selected. The first intervention group consumes 5% Halileh black topical gel 3 times a day locally on the knee. Participants will be informed that the type of treatment they received will not be known to avoid bias. They are also encouraged not to guess which treatment they received during the study. The second intervention group: 26 patients with knee osteoarthritis are selected. The second intervention group uses diclofenac 1% topical gel 3 times a day. Control group: 26 patients with knee osteoarthritis are selected. The control group consumes placebo gel 3 times a day. Knee pain. Timepoint: The first, third and the first, third and sixth weeks after the start of the intervention. Method of measurement: Based on VAS and WOMAC Patients' pain is measured through the VAS (Visual Analogue Scale) questionnaire and their performance through the Womac (Western Ontario and McMaster Universities Index) questionnaires. Shahre-kord University of Medical Sciences Approved 2024-01-03 Ethics Committee of Medical School of Medical Sciences of Shahrekord University of Medical Sciences Kashani street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)