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IRCT20170725035305N4 IRCT 2020-05-02 Shahid Beheshti University of Medical Sciences The effects of Portulaca Oleracea extract on thirsty and 24 hour urine indices The effects of Portulaca Oleracea extract on thirsty and 24 hour urine indices in patients with renal stone: a double-blind randomized placebo-controlled clinical trial 2020-07-22 anticipated 60 Complete https://irct.ir/trial/42388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of balanced block randomization used with a block size of 4. For the allocation sequence, we applied computer-generated by random numbers. Medicines containing Oleracea extract or placebos with the same shape and color numbered with a code in sealed envelopes. Each coded prepared medication with a label by one number from 1 to 60. The patients allocated into two groups: group 1(n=30) received Oleracea extract, and group2 (n=30 ) received placebo . Both groups were identical in terms of characteristics and comorbid conditions; the participants divided sequentially.The control group is assigned to "A" and the intervention group to "B", and then the two groups are divided into 6 blocks: (1) AAB, (2) B A A, (3 (B), b), b), b), b), b), b) These blocks are randomly put together by computer and provide a chain of randomized groups (eg: B A B B A B B A B B A B B). Then the patients enter these groups in order of entry, Blinding description: During study period ,a nurse coordinated the study and registered the study codes and the nurse handed the labeled drugs over participants and collected all the data. The patients , investigators , laboratory staffs and supervisers all were blinded to treatment assignment and lab data measurements during the study. 2-3 Patients with kidney stones. Intervention 1: Intervention group: The intervention group (n = 30) received a capsul containing of 2 grams Portulaca Oleracea hydro alcoholic extract and half a gram of brown sugar should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks. Intervention 2: Control group: The second group (30 patients) received placebo as a capsul containing of 2 grams starch powder and half a gram of brown sugar ( placebo ) should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks. Yes - There is a plan to make this available What will be shared: All collected data c is an be shared after making participants unidentifiable. When: starting after publication To whom: people working in academic institutions Conditions: Any types of analyses Where to obtain: Email :amirhesam124@gmail.com How to obtain: less than 2 weeks Comments:
public Amirhesam Alirezaei
Shahid Modaress hospital, after Kaaj square, Saadatabad, Tehran
tehran Iran (Islamic Republic of) 1998734383 +212 2083112 amirhesam124@gmail.com Shahid Beheshti University of Medical Sciences scientific Amirhesam Alirezaei
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311
tehran Iran (Islamic Republic of) 1998734383 +98 21 2208 3112 Amirhesam124@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years Literate 18 years 65 years Both Patients with diabetes Oral problems No use of angiotensin II inhibitors Patients with colds N20.0 Calculus of kidney and ureter Treatment - Drugs Placebo Intervention group: The intervention group (n = 30) received a capsul containing of 2 grams Portulaca Oleracea hydro alcoholic extract and half a gram of brown sugar should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks Control group: The second group (30 patients) received placebo as a capsul containing of 2 grams starch powder and half a gram of brown sugar ( placebo ) should be taken with 100 cc of water and standard treatment based on urine metabolic evaluation for 8 weeks Serum Potassium level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum Sodium level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. 24-hour urine uric acid. Timepoint: At the start of the study and at the end of the study. Method of measurement: 24 h Urine collection. 24-hour urine citrate. Timepoint: At the start of the study and at the end of the study. Method of measurement: 24 h Urine collection. Specific weight of urine. Timepoint: At the start of the study and at the end of the study. Method of measurement: Urine sample. 24 hour urine calcium. Timepoint: At the start of the study and at the end of the study. Method of measurement: 24 h Urine collection. 24-hour urine creatinine. Timepoint: At the start of the study and at the end of the study. Method of measurement: 24 h Urine collection. 24-hour urine Na. Timepoint: At the start of the study and at the end of the study. Method of measurement: 24 h Urine collection. Thirst intensity. Timepoint: At the start of the study, at the end of the study. Method of measurement: using Visual Analogue Scale. Serum triglycerid level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum cholestrol level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum HDL level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Total antioxidant level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. ESR. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. CRP. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum Uric acid level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum Creatinine level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum Urea level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Serum calcium level. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Venous blood gas. Timepoint: At the start of the study and at the end of the study. Method of measurement: blood sample. Shahid Beheshti University of Medical Sciences Approved 2019-09-16 Ethics committee of Shahid beheshti University of Medical Sciences 7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran. tehran Tehran Iran (Islamic Republic of)