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IRCT20170725035305N3 IRCT 2019-08-09 Shahid Beheshti University of Medical Sciences Descurainia Sophia in hemodialysis patients HDS Evaluating the effects of Descurainia Sophia on serum inflammatory markers and thirst alleviation in hemodialysis patients 2018-12-22 anticipated 60 Complete https://irct.ir/trial/35573 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: 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 seed 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 randomly allocated into two experimental groups: group 1(n=30) initially received Intervention D.S extract, and group2 (n=30 ) received placebo initially. 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 hemodialysis patients. Intervention 1: The first intervention group (n = 30) initially received an extract of Descuria.Sophia containing 2 grams of D,Sophia powder and half a gram of brown sugar with 100 cc of water for 4 weeks, and after 2 weeks of washout period and followd by 4 weeks of placebo intake containing 2 grams of Starch powder and half a gram of brown sugar with 100 cc water. Intervention 2: Control group: The second intervention group (30 patients). At first,recieved 4 weeks of the placebo containing 2 grams of starch powder and half a gram of brown sugar with 100 cc of water, and after 2 weeks of washout period, followed by recieving Descuiria.Sophia extract containing 2 grams of D.Sophia powder and half a gram of brown sugar received with 100 cc water for 4 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 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) Iran (Islamic Republic of) age between 18 - 70 years old on hemodialysis for more than 3 months KT/V > 1.2 insensitive to D. Sophia or any herbal remedy no history of active infection in the past month using AVF for Hemodialysis 18 years 70 years Both sensitivity to D. Sophia or any herbal remedy history of active infection in the past month unwilling to participate for any reason using permcath or AVG for hemodialysis hospital admission for any reason in past month and during the study period. N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Placebo The first intervention group (n = 30) initially received an extract of Descuria.Sophia containing 2 grams of D,Sophia powder and half a gram of brown sugar with 100 cc of water for 4 weeks, and after 2 weeks of washout period and followd by 4 weeks of placebo intake containing 2 grams of Starch powder and half a gram of brown sugar with 100 cc water. Control group: The second intervention group (30 patients). At first,recieved 4 weeks of the placebo containing 2 grams of starch powder and half a gram of brown sugar with 100 cc of water, and after 2 weeks of washout period, followed by recieving Descuiria.Sophia extract containing 2 grams of D.Sophia powder and half a gram of brown sugar received with 100 cc water for 4 weeks. MDA (Malondialdehyde). Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: serum level and biochemistry analysis. Potassium serum level. Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: blood sample. Lipid profile. Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: blood sample. Total antioxidation capacity. Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: blood sample. Hemocystein serum level. Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: blood sampling. Thirst intensity. Timepoint: At the start of the study, before wash out, after wash out and at the end of the study. Method of measurement: using Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2018-12-22 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)