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IRCT20080901001165N62 IRCT 2020-07-02 Bagheiat-allah University of Medical Sciences The effect of licorice and ginger herbal composition on controlling patients' pain symptoms after knee joint replacement surgery Evaluation of the efficacy and safety of Glycyrrhiza glabra and zingiber officinale in controlling pain symptoms in patients after Total Knee Arthroplasty(TKA) 2020-09-21 anticipated 100 Complete https://irct.ir/trial/49058 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the Block Randomization method will be used using four and six blocks with random order. We will use Excel software and rand function to prepare random arrangements. The created files will be stored with the study epidemiologist during the production process of the random chain and its results, Blinding description: Concealment A four-digit numeric code will be assigned to each of the random loop loops. The chain is generated centrally through a responsible person using a phone call or through a website The Interactive Web Response System will be dedicated to the study centers. In this way, each of the centers will be given one or more usernames and passwords to enter the website through it. Upon arrival, the patient will receive the initial information and then, to ensure that he or she has the consent and the conditions to enter the study, the randomization code will be assigned to him / her based on a predetermined random chain. Blinding This is a triple blind study and a placebo drug was designed for it, which is completely compatible with the body in terms of safety and has no side effects. 1-2 Osteoarthritis, Total knee arthroplasty (TKA), Pain after surgery. Intervention 1: Intervention group:They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Furthermore, the herbal combination of licorice and ginger ( capsules 500 mg) will be prescribed every 12 hours for 8 weeks. Intervention 2: Control group: They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Also, 500 mg of plasbo capsule will be prescribed every 12 hours for 8 weeks. Yes - There is a plan to make this available What will be shared: Participants' data files, study protocol, statistical analysis map, statistical analysis, clinical study report and classification system will be shared. However, after making people unrecognizable, part of the data, such as information about the main consequence or the like, can be shared one hundred percent. When: The access period will start 6 months after publication To whom: Data will only be available to researchers working at academic and scientific institutions Conditions: After publishing the data and the article, any kind of analysis is allowed by mentioning the source Where to obtain: Sheikh Bahaie South Street, Mulla Sadra Street, Vanak Square, Tehran, IRAN.School of Pharmacy How to obtain: After the communication is established, the applicant must submit a written request to the relevant organization and the request will be answered within 4-5 months Comments:
public Alireza Rahimnia
Sheikh Bahaie South Street, Mulla Sadra Street, Vanak Square, Tehran, IRAN.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5131 dr.rahimnia@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Yunes Panahi
Sheikh Bahaie South Street, Mulla Sadra Street, Vanak Square, Tehran, IRAN.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5131 yunespanahi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients are candidates for complete knee replacement after surgery and hospital discharge no limit no limit Both Inflammatory underlying disease such as rheumatoid arthritis Drug addiction smoking M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Drugs Treatment - Drugs Intervention group:They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Furthermore, the herbal combination of licorice and ginger ( capsules 500 mg) will be prescribed every 12 hours for 8 weeks Control group: They will receive a diclofenac treatment (75 mg daily) one hour after meals daily. Also, 500 mg of plasbo capsule will be prescribed every 12 hours for 8 weeks Comparison of the effect of different doses of licorice and ginger herbal composition in one group and diclofenac drug in the second group. Timepoint: Before the intervention, and 8, 12 and 24 hours after consuming the herbal combination, licorice and ginger, every 12 hours to 8 weeks. Method of measurement: The pain VAS is a unidimensional measure of pain intensity. Post-intervention Quality of life score. Timepoint: Up to 28 weeks after the intervention. Method of measurement: It will be measured according to the Cop Corn questionnaire. Bagheiat-allah University of Medical Sciences Approved 2020-03-13 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah Hospital, Mollasadra St, Vanak Sq, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)