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IRCT20081011001323N26 IRCT 2020-12-04 Yasouj University of Medical Sciences Effect of combined extracts of cinnamon , black pepper and Valerian on improvement of urinary tract pain Comparison effect of combined extracts of cinnamon , black pepper and Valerian with oral diclofenac on improvement of urinary tract pain in adults 2020-12-21 anticipated 80 Complete https://irct.ir/trial/51320 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients are allocated randomly with simple sequential allocation in one of the two study groups (combined extract of three herbs or diclofenac) by help of sealed envelope and receive the intervention of the same group. The unit of randomization will be the referred patient. In every envelope, one of two codes (A=combined extract) or (B=diclofenac) will be taken. The sealed envelopes will be placed at the disposal of the expert. With the referral of each patient one of the envelopes will be randomly selected by the patients and will be introduced as a study group. The stratification approach is not used. Concealment will not take place in the study. 2-3 Urinary tract pain. Intervention 1: Intervention group: The combination of cinnamon extract, black pepper and Valerian in equal proportions and in the form of capsules (Armaghan Salamat Zagros Yasuj Company) is prepared and prescribed at a dose of 500 mg every 8 hours after a meal with a glass of water for 10 days. Intervention 2: Control group: Tab diclofenac Na 50 mg every 8 hour is prescribed with a glass of water for two weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Sadrollah Mehrabi
Shahid Mofateh clinic, Montazeri street,Yasuj,Iran
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3322 1812 sadrollahm@yahoo.com Yasouj University of Medical Sciences scientific Sadrollah Mehrabi
Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3322 9297 dr.mehrabi@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Age older than 18 year old complain from flank pain or urinary tract pain Having informed consent to enter study 18 years no limit Both Uncontrolled coagulopathy Azotemia Pregnancy Presence of active urinary tract infection Allergy to medical or herbal drugs Suffering from cardiovascular or pulmonary disease Suffering from hepatic disease R39 Other and unspecified symptoms and signs involving the genitourinary system Treatment - Drugs Treatment - Drugs Intervention group: The combination of cinnamon extract, black pepper and Valerian in equal proportions and in the form of capsules (Armaghan Salamat Zagros Yasuj Company) is prepared and prescribed at a dose of 500 mg every 8 hours after a meal with a glass of water for 10 days. Control group: Tab diclofenac Na 50 mg every 8 hour is prescribed with a glass of water for two weeks. The severity of pain in urinary tract. Timepoint: During the study , two weeks and one month after starting treatment. Method of measurement: With Visual Analogue Scale (VAS). Developing drug allergy and hypersensitivity. Timepoint: During and at the end of study. Method of measurement: Patients records and exam. Developing renal complications. Timepoint: During and at the end of study. Method of measurement: Check of urine and renal function tests. Yasouj University of Medical Sciences Approved 2020-11-29 Ethics committee of Yasuj University of Medical Sciences Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)