The aim of this study is evaluation of efficacy of cystone on stone expulsion after extracorporeal shock wave lithotripsy (ESWL). Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into intervention and control group. Randomization will be performed using random block sizes of 4. The study is randomized, placebo-free, single-center, phase 3 trial. Inclusion criteria : Patients with kidney stones < 2 cm. Exclusion criteria: history of kidney surgery; concurrent use of other drugs for treatment of kidney stones; hydronephrosis. sample size:100 patients are participated in the study with 50 patients in each group.The intervention used in the study: cystone 5 mg orally twice daily from the beginning of Lithotripsy (ESWL) until one month. Primary outcomes: accelerate expulsion of stone after Lithotripsy; Reducing the side effects of other drugs such as hydrochlorothiazide after Lithotripsy; Preventing the need for surgery after Lithotripsy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042221900N1
Registration date:2016-08-31, 1395/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
Azadeh Khamedi
Name of organization / entity
Islamic Azad University Shahrood branch
Country
Iran (Islamic Republic of)
Phone
+98 232237331
Email address
med.rsh@iau-sharood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cystone on stone expulsion after extracorporeal shock wave lithotripsy: a randomized clinical trial
Public title
The effect of cystone on stone expulsion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with kidney stones smaller than 2 cm. Exclusion criteria: history of kidney surgery, Concomitant use of other drugs for treatment of kidney stones; hydronephrosis.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using random block sizes of 4.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
Shahrood University of Medical Sciences, Haft Tir Square, Shahrood
City
Shahrood
Postal code
3613773955
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930/32
Health conditions studied
1
Description of health condition studied
Kidney and urinary tract stone
ICD-10 code
N20،N21،N2
ICD-10 code description
N20 Calculus of kidney and ureter - N21 Calculus of lower urinary tract - N22* Calculus of urinary tract in diseases classified elsewhere- N23 Unspecified renal colic
Primary outcomes
1
Description
Kidney stone expulsion
Timepoint
Before and one month after intervention
Method of measurement
Abdominal X-ray, CT scan and sonography
Secondary outcomes
1
Description
Therapy sessions of kidney Lithotripsy
Timepoint
Six months after the first Lithotripsy
Method of measurement
Record number of doing Lithotripsy
Intervention groups
1
Description
Intervention group: Cystone 5 mg oral tablet, twice a day (every 12 hours) from the begining of Lithotripsy until one month.
Category
Treatment - Drugs
2
Description
Control group: Non-use of cystone 5 mg oral tablet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein education, Research and Treatment Center, Shahrood
Full name of responsible person
Dr.Amin Amini.Urologist
Street address
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Dr Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Azade khamedi
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood