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IRCT20200105046009N7 IRCT 2023-01-09 Babol University of Medical Sciences The effect of topical chamomile herbal product on the symptoms of patients with muscle cramps The effect of topical chamomile herbal product on the symptoms of patients with leg cramps in comparison with standard treatment: a double-blind clinical trial 2023-01-20 anticipated 64 Complete https://irct.ir/trial/67879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using the permuted block randomization method. The size of the blocks is 4 and the ratio of drug to control (diclofenac gel) in each group is equal to (1:1). In each block, random permutations of 4 combinations of chamomile formulation and diclofenac gel are considered. Random sequence generation will be done by the design methodologist. In order to hide the treatment process, random codes are written on the boxes containing medicine (chamomile product/diclofenac) and after assigning the medicine to the patients, the corresponding code is recorded on the patients' files. The opening of the codes will be done after the end of the study. In case of side effects, the code of that medicine will be opened, Blinding description: Chamomile product and diclofenac gel in a single form, with the same label and the same smell and color (with the addition of color and essential oil) will be prepared by a pharmaceutical specialist in the medicinal plant laboratory of the Faculty of Iranian Medicine in Babol. The only person who knows the nature of drugs is the pharmacist who makes the drug. 3 muscle cramp. Intervention 1: Chamomile topical product (combination of chamomile oil and wax made in the laboratory of the Iranian Faculty of Medicine) in the amount of one knuckle every eight hours is used topically on the leg muscles and the VAS index, before the intervention and on even days after The start of the intervention is measured and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. Intervention 2: 1% diclofenac gel of Soban company is used topically on the calf muscles in the amount of one knuckle every eight hours, and the VAS index is measured before the intervention and on even days after the intervention, and the treatment is continued until the day the pain index is reached. Continued to number 4 or a rate of change of 1.7 based on MCID. 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 more information
public Seyyed Ali Mozaffarpur
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4728 dr.mozaffarpur@mubabol.ac.ir Babol University of Medical Sciences scientific Seyyed Ali Mozaffarpur
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4728 dr.mozaffarpur@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Men and women aged 20 to 60 years Presence of muscle cramp in the gastrocnemius muscle The presence of pain with a vas score greater than six 20 years 60 years Both Lack of complete evaluation to monitor the treatment process Lack of satisfaction during treatment The presence of underlying diseases related to cramps Using other painkillers Performing procedures that lead to the improvement of muscle cramps History of recurrent cramps without clear cause R25.2 Cramp and spasm Treatment - Drugs Treatment - Drugs Chamomile topical product (combination of chamomile oil and wax made in the laboratory of the Iranian Faculty of Medicine) in the amount of one knuckle every eight hours is used topically on the leg muscles and the VAS index, before the intervention and on even days after The start of the intervention is measured and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. 1% diclofenac gel of Soban company is used topically on the calf muscles in the amount of one knuckle every eight hours, and the VAS index is measured before the intervention and on even days after the intervention, and the treatment is continued until the day the pain index is reached. Continued to number 4 or a rate of change of 1.7 based on MCID Pain index. Timepoint: The VAS measurement is measured before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. Method of measurement: Pain intensity measurement using VAS tool. Duration of treatment. Timepoint: VAS is measured before the intervention and on even days after the start of the intervention, and the examination of the pain index continues until the day it reaches the number 4 or the change rate of 1.7 based on the MCID. Method of measurement: Pain intensity measurement using VAS tool. Redness. Timepoint: Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. Method of measurement: By patient report or evaluator observation. Itching. Timepoint: Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. Method of measurement: By patient report or evaluator observation. Swelling. Timepoint: Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID. Method of measurement: By patient report or evaluator observation. Babol University of Medical Sciences Approved 2023-01-02 Ethics committee of Babol University of Medical Sciences Babol University of Medical sciences, Sargord Ghasemi avenue, Babol Babol Mazandaran Iran (Islamic Republic of)