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IRCT20181218042039N1 IRCT 2019-04-27 Kerman University of Medical Sciences fenugreek extract effect on pain relief Study of the slow release fenugreek (Trigonella foenum-graecum ) seed formulation on pain relief in patients with temporomandibular disorder 2019-03-01 anticipated 60 Complete https://irct.ir/trial/36111 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, the studied and the standard drug in dosage form and packaging are quite similar. Each label has A or B letter that is known by investigator which letter belong to the studied or standard drug.Each patient receives only one arbitration package. After explaining the study process, the patients will be told that the chance of being in each group will be one second and after signing the consent form, with full knowledge of the research process, they will be included in the study. 3 Temporomandibular disorders. Intervention 1: Intervention group: Fenugreek seed extract, with amount of 600 mg in each capsule, twice a day, in two weeks, once every 12 hours, after meal. Intervention 2: Control group: naproxen capsules, with amount of 500 mg in each same capsules, twice a day, in two weeks, once every 12 hours, after meal, Pars darou company. No - There is not a plan to make this available Justification or reason for not sharing IPD is The results may show effectiveness of the drug, therefor we want to make patent.
public Mehdi Ansari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 761913555 +98 34 3132 5022 mansari@kmu.ac.ir Kerman University of Medical Sciences scientific Mehdi Ansari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5022 mansari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Men and women over 14 years of age Patients who be able to respond to the mentioned forms Patients wishing to enter the study 14 years no limit Both Pregnancy and lactation in women Patients with Diabetes Mellitus patients who take statin drugs Sensitivity to Fenugreek or other herbs Patients with history of coagulation disorders Patients undergoing orthodontic or orthopedic procedures Patients treated with anti psychotropic, anti-inflammatory and analgesic drugs and splint therapy Patients with dental caries that imitate pain in the head and face Patients with periodontal problems Patients with pathologic problems in the head and face M26.60 Temporomandibular joint disorder, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Fenugreek seed extract, with amount of 600 mg in each capsule, twice a day, in two weeks, once every 12 hours, after meal Control group: naproxen capsules, with amount of 500 mg in each same capsules, twice a day, in two weeks, once every 12 hours, after meal, Pars darou company Reduce pain in Visual Analogue Scale and Brief Pain Inventory questionnaire. Timepoint: at beginning of the study and after 14th , 28th days of the beginning of the study. Method of measurement: Visual Analogue Scale and Brief Pain Inventory of pain questionnaire. GI upset. Timepoint: Two and four weeks after drug administration. Method of measurement: Patient claim and Questionnaire fullfilment. Kerman University of Medical Sciences Approved 2018-12-18 Ethics commitee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Deputy of research and technology, Student research committee, Tahmasebad acrossroads, beginning at Ibn Sina street Kerman Kerman Iran (Islamic Republic of)