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General information
2018-07-23, 1397/05/01
2019-07-23, 1398/05/01
20182019-07-23 00:00:00
2018-09-23, 1397/07/01
2019-09-23, 1398/07/01
20182019-09-23 00:00:00
2018-07-23, 1397/05/01
2019-07-23, 1398/05/01
20182019-07-23 00:00:00
2018-09-23, 1397/07/01
2019-09-23, 1398/07/01
20182019-09-23 00:00:00
2018-09-23, 1397/07/01
2019-09-23, 1398/07/01
20182019-09-23 00:00:00
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Correction of the start and end date of the enrollment
Correction of the start and end date of the enrollment
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اصلاح تاریخ شروع و اتمام بیمارگیری
اصلاح تاریخ شروع و اتمام بیمارگیری
Recruitment centers
#1
Name of recruitment center - English: 22 Bahman Neyshabur Hospital
Name of recruitment center - Persian: بیمارستان 22 بهمن نیشابور
Full name of responsible person - English: Vahid moeini
Full name of responsible person - Persian: وحید معینی
Street address - English: Neyshabur University of Medical Sciences
Street address - Persian: دانشگاه علوم پزشکی نیشابور
City - English: Neyshabur
City - Persian: نیشابور
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6623451124
Phone: +98 51 4334 4711
Fax:
Email: v.moini@yahoo.com
Web page address:
Name of recruitment center - English: 22 Bahman Neyshabur Hospital
Name of recruitment center - Persian: بیمارستان 22 بهمن نیشابور
Full name of responsible person - English: Vahid Moeini
Full name of responsible person - Persian: وحید معینی
Street address - English: 22 Bahman Neyshabur Hospital, Imam Khomeini Blvd,Imam Khomeini Square,Neyshabur
Street address - Persian: نیشابور، میدان امام خمینی، بلوار امام خمینی،بیمارستان 22 بهمن
City - English: Neyshabur
City - Persian: نیشابور
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6623451124
Phone: +98 51 4334 4711
Fax: +98 51 4262 7500
Email: info@nums.ac.ir
Web page address:
Name of recruitment center - English: 22 Bahman Neyshabur Hospital Name of recruitment center - Persian: بیمارستان 22 بهمن نیشابور Full name of responsible person - English: Vahid moeiniMoeini Full name of responsible person - Persian: وحید معینی Street address - English: 22 Bahman Neyshabur University of Medical SciencesHospital, Imam Khomeini Blvd,Imam Khomeini Square,Neyshabur Street address - Persian: دانشگاه علوم پزشکی نیشابور، میدان امام خمینی، بلوار امام خمینی،بیمارستان 22 بهمن City - English: Neyshabur City - Persian: نیشابور Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 6623451124 Phone: +98 51 4334 4711 Fax: +98 51 4262 7500 Email: v.moiniinfo@yahoo.comnums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vahid moeini
Full name of responsible person - Persian: وحید معینی
Street address - English: Neyshabour University of Medical Sciences
Street address - Persian: دانشگاه علوم پزشکی نیشابور
City - English: Neyshabour
City - Persian: نیشابور
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6623451124
Phone: +98 51 4334 4711
Fax:
Email: v.moini@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Shamshirgaran
Full name of responsible person - Persian: مرتضی شمشیرگران
Street address - English: Neyshabur University of Medical Sciences, Janbazan Blvd, Qods Town, Neyshabur
Street address - Persian: نیشابور، شهرک قدس، بلوار جانبازان، دانشگاه علوم پزشکی نیشابور
City - English: Neyshabour
City - Persian: نیشابور
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6623451124
Phone: +98 51 4334 4711
Fax:
Email: v.moini@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vahid moeiniMorteza Shamshirgaran Full name of responsible person - Persian: وحید معینیمرتضی شمشیرگران Street address - English: NeyshabourNeyshabur University of Medical Sciences, Janbazan Blvd, Qods Town, Neyshabur Street address - Persian: نیشابور، شهرک قدس، بلوار جانبازان، دانشگاه علوم پزشکی نیشابور City - English: Neyshabour City - Persian: نیشابور Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 6623451124 Phone: +98 51 4334 4711 Fax: Email: v.moini@yahoo.com Web page address:
Protocol summary
Study aim
Evaluation of the effect of Alhagi distillate on ureteral stone expulsion
Design
This study is a clinical trial. In this study, 110 patients will be randomly divided into intervention and control groups.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Rate of ureteral stone expulsion
General information
Reason for update
Correction of the start and end date of the enrollment
Acronym
IRCT registration information
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
Registration date
2019-04-06, 1398/01/17
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
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
The effect of Alhagi distillate on ureteral stone expulsion
Public title
The effect of Alhagi distillate on ureteral stone expulsion
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
110
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
2018-04-15, 1397/01/26
Ethics committee reference number
IR.NUMS.REC.1397.003
Health conditions studied
1
Description of health condition studied
ureteral stone
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
Primary outcomes
1
Description
The amount of stone disposal
Timepoint
Check the presence and exact location of the stone before the intervention and one week after the intervention.
Method of measurement
Using a checklist that includes: Clinical examination, patient interview, and ultrasound.
Secondary outcomes
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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) 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.
Category
Treatment - Other
2
Description
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).