The effect of Alhagi maurorum distillate on renal and upper ureteral stones expulsion after Extracorporeal shock wave lithotripsy (ESWL): randomized clinical trial
Determining the effect of Harsh sweat on excretion of kidney and upper ureteral stones after extracorporeal lithotripsy
Design
This study is a randomized clinical trial. Patients referred to the specialized clinic of 22 Bahman Hospital in Neyshabour who are diagnosed with renal colic secondary to urinary stones. In this study, 140 patients will be randomly divided into intervention and control groups.
Settings and conduct
Patients referred to the specialized clinic of 22 Bahman Hospital in Neyshabour who are diagnosed with renal colic secondary to urinary stones will be examined. In this study, patients will be examined by a urologist and by methods such as KUB, ultrasound, CT scan and in some cases by intravenous urography, complete urinalysis and routine blood tests. The size of the stone and its location will be identified and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: complete the informed consent form; age between 18 and 70 years old; stones with a diameter between 5-20 mm; stones in the pelvis, middle and upper calyx (other than lower calyx).
Exclusion criteria: patient's unwillingness to continue cooperation; pregnancy; uncontrolled urinary tract infections; patients with coagulation problems
Severe spinal deformities; patients with gastric ulcer problem (because the use of painkillers exacerbates this problem); severe hydronephrosis; inadequate renal function (creatinine above 2 mg /dL); BMI above 30; ESWL history unsuccessful; history of surgery on the urinary system; abdominal aortic and renal artery aneurysms; patients taking alpha blocker or calcium blocker.
Intervention groups
Patients in the control group will receive one capsule of tamsulosin 0.4 mg daily and 100 mg diclofenac suppository daily. Patients in the intervention group, in addition to receiving routine treatments, will receive 150 cc of Haresht sweat daily in 3 divided doses.
Main outcome variables
Rate of stone expulsion after ESWL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150511022218N6
Registration date:2022-06-25, 1401/04/04
Registration timing:registered_while_recruiting
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Vahid Moeini Ghamchini
Name of organization / entity
Neyshabour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4062
Email address
v.moinighamchini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alhagi maurorum distillate on renal and upper ureteral stones expulsion after Extracorporeal shock wave lithotripsy (ESWL): randomized clinical trial
Public title
The effect of Alhagi maurorum distillate on renal and upper ureteral stones expulsion after Extracorporeal shock wave lithotripsy (ESWL): randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing consent form
Age between 18 and 60 years
Stones with a diameter between 5-20 mm
Stones in the pelvis, middle and upper calyx (except lower calyx)
Exclusion criteria:
The patient's unwillingness to continue cooperating
Pregnancy
Uncontrolled urinary tract infection
Patients with coagulation problems
Severe spinal deformities
Patients with gastric ulcer problem (because the use of painkillers exacerbates this problem)
Severe hydronephrosis
Inadequate renal function (creatinine above 2 mg / dL)
BMI above 30
ESWL history unsuccessful
History of urinary tract surgery
Abdominal aortic and renal artery aneurysms
Patients taking alpha blocker or calcium blocker
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the subjects were divided into intervention and control groups in blocks of 4 using randomized block method. For this purpose, first, all possible states were assigned, as half of the subjects to group A (intervention group) and the other half to group B (control group), including AABB, BBAA, ABAB, BABA, ABBA, BAAB. Then, one of the digits 1 to 6 was assigned to each of the combinations of 4, and choices from 1 to 6 were randomly selected with replacement. The selected blocks were recorded as a serial sequence. Each individual entering the study received a treatment A or B in terms of sequence. Random selection of the blocks continued until reaching the sample size of the study
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences, Janbazan Blvd, Qods Town, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.NUMS.REC.1400.049
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Rate of the stone expulsion
Timepoint
Interventions will begin the day before the ESWL process and will continue daily until the stone is expelled. Stone removal In this study, we define complete stone removal or the remaining broken pieces of stone less than 3 mm during the two weeks to three months after the procedure.
Method of measurement
En Using a checklist that includes: Clinical examination, patient interview, and ultrasound.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this study the intervention group, in addition to receiving routine treatments (daily one 0.4 mg tamsulosin capsule(Farabi Pharmacy), diclofenac suppositories of 100 mg(Sobhan Pharmacy), will receive 150 cc of Alhagi distillate daily in 3 divided doses. They will consume from the day before the intervention until the stone is expulsion.
Category
Treatment - Other
2
Description
Control group: patients in the control group will receive one capsule of tamsulosin 0.4 mg daily and 100 mg diclofenac suppository daily.