Protocol summary
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Study aim
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Evaluation of the effect of Alhagi distillate on ureteral stone expulsion
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Design
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This study is a clinical trial. In this study, 110 patients will be randomly divided into intervention and control groups.
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Settings and conduct
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In this study, the patients referred to the special clinic of the 22 Bahman Hospital in Neyshabur who have been diagnosed with secondary renal colic in the ureter have been introduced and included in the research units.Patients in this study were examined through the diagnosis of a urologist by methods such as taking kidney, ureter, and bladder (KUB) images, sonography, and full urine analysis. The stone size and location were detected and recorded.At the beginning of the study, the patients were asked about the history of drug use, so that they did not enter the design if those drugs interfered with the Alhagi Pseudalhagi distillate. Moreover, patients with a history of use of an herbal medicine effective on stone removal before their referral to the doctor, did not enter the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Having consent form, Ureteral stones smaller than 1 cm, All patients with renal colic pain with kidney stones diagnosis, Age between 20 and 60 years.
Exclusion criteria: Severe or progressive Hydronephrosis, Urinary tract infection, The patients symptoms can not be tolerated.
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Intervention groups
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In this study, patients in the control group daily received one 0.4 mg tamsulosin capsule(Farabi Pharmacy), diclofenac suppositories of 100 mg(Sobhan Pharmacy) and Cefixime 200 mg(Farabi Pharmacy) every twelve hours (routine intervention determined by a physician based on American nephrology protocols). The intervention group, in addition to receiving routine treatments, will receive 150 cc of Alhagi distillate(Qadah Kashan co) daily in 3 divided doses for a period of 4 weeks.
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Main outcome variables
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Rate of ureteral stone expulsion
General information
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Reason for update
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Correction of the start and end date of the enrollment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150511022218N5
Registration date:
2019-04-06, 1398/01/17
Registration timing:
prospective
Last update:
2022-02-24, 1400/12/05
Update count:
1
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Registration date
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2019-04-06, 1398/01/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-23, 1398/05/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2019-07-23, 1398/05/01
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Actual recruitment end date
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2019-09-23, 1398/07/01
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Trial completion date
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2019-09-23, 1398/07/01
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Scientific title
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The effect of Alhagi distillate on ureteral stone expulsion
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Public title
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The effect of Alhagi distillate on ureteral stone expulsion
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having Consent form
All patients with renal colic pain with kidney stones diagnosis
Ureteral stones smaller than 1 cm
Age between 20 and 60 years
Exclusion criteria:
Severe or progressive hydronephrosis
Urinary tract infection
The patient's symptoms can not be tolerated
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
110
Actual sample size reached:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-15, 1397/01/26
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Ethics committee reference number
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IR.NUMS.REC.1397.003
Health conditions studied
1
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Description of health condition studied
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ureteral stone
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ICD-10 code
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N21
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ICD-10 code description
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Calculus of lower urinary tract
Primary outcomes
1
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Description
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The amount of stone disposal
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Timepoint
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Check the presence and exact location of the stone before the intervention and one week after the intervention.
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Method of measurement
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Using a checklist that includes: Clinical examination, patient interview, and ultrasound.
Intervention groups
1
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Description
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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) and Cefixime 200 mg(Farabi Pharmacy) every twelve hours), will receive 150 cc of Alhagi distillate(Qadah Kashan Co) daily in 3 divided doses for a period of 4 weeks.
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Category
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Treatment - Other
2
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Description
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Control group:In this study, patients in the control group daily received one 0.4 mg tamsulosin capsule(Farabi Pharmacy), diclofenac suppositories of 100 mg(Sobhan Pharmacy) and Cefixime 200 mg(Farabi Pharmacy) every twelve hours (routine intervention determined by a physician based on American nephrology protocols).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Neyshabour University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The researcher only intends to publish the article and there is no plan for publication in this study
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available