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IRCT20081011001323N23 IRCT 2019-05-03 Yasouj University of Medical Sciences Effect of Nigella sativa and tamsulosin on urinary stones Comparison effect of Nigella sativa and tamsulosin on pain improvement and passage of renal and ureteral stones sized 4-10 millimeter 2019-02-09 anticipated 80 Complete https://irct.ir/trial/35993 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 (Nigella sativa or tamsulosin) 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=Nigella sativa) and or (B=tamsulosin) 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 Calculus of kidney and ureter. Intervention 1: Intervention group: Nigella sativa in form of capsule(produced by Salamat Zagros company) will prepare and prescribed in divided dosage of 15mg/kg (milligram/kilogram) per day after meal with one glass of water for two weeks. Intervention 2: Control group: Tamsulosin capsule 0.4 mg (produced by Abidi Company) will prescribe every night with one 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
Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
Yasuj Iran (Islamic Republic of) 7591741417 +98 33346070 dr.mehrabi@yums.ac.ir Yasouj University of Medical Sciences scientific Sadrollah Mehrabi
Vice chancellor for Education, Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3334 6070 dr.mehrabi@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Age more than18 years old Suffering from renal or ureteral stone less than 10 millimeter Having informed consent form 18 years 99 years Both Uncontrolled coagulopathy Pregnancy Azotemia Allergy to medical or herbal drugs Severe cardiovascular or pulmonary disease N20.2 Calculus of kidney with calculus of ureter Treatment - Drugs Treatment - Drugs Intervention group: Nigella sativa in form of capsule(produced by Salamat Zagros company) will prepare and prescribed in divided dosage of 15mg/kg (milligram/kilogram) per day after meal with one glass of water for two weeks. Control group: Tamsulosin capsule 0.4 mg (produced by Abidi Company) will prescribe every night with one glass of water for two weeks. Passage of renal and upper ureteral stones with sizes from 4-10 millimeter. Timepoint: Two weeks and one month after start of treatment. Method of measurement: Taking KUB(kidney,ureter and bladder) and ultrasonography and report of patients. Pain severity score due to passage of stones. Timepoint: During study and two weeks and one month after start of treatment. Method of measurement: With Visual Analogue Scale(VAS). Yasouj University of Medical Sciences Approved 2019-03-09 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)