Protocol summary

Study aim
Investigating the effect of oral theophylline on complications caused by double J: A Double Blind Clinical Trial
Design
The study is an interventional study in two control groups (30 people) and intervention (30 people), double-blind (patient and researcher), phase 3, parallel and therapeutic.
Settings and conduct
This clinical trial will be conducted in Sina Hospital, Urology Research Center, on 60 patients. The first group: Double G treatment along with placebo (30 people). Second group: Double G treatment group along with theophylline (30 people).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing trans ureteral lithotripsy Patients under the endoscopic ureter For other cases that have a bleeding effect, double G is installed for them, Written and informed consent from patients Exclusion criteria: Symptoms of prostatitis/ asthma/ being a smoker Diabetes Gastrointestinal discomfort Insomnia and tremors Taking potassium-sparing diuretics Taking digoxin in patients with heart problems Taking levodopa Taking calcium supplements at the same time/ Taking spironolactone tablets Previous history of hyperkalemia Taking triamterene Taking tablets Amiloride High blood potassium and pregnancy
Intervention groups
Treatment group, Double G, along with the use of Teolite with the generic name of Theophylline Retard with a dose of 200 mg, Obidi company, 30 tablets, one daily for one month. Treatment group, double G, and placebo (a capsule containing sugar that looks similar to a probiotic capsule and is prescribed for 4 weeks).
Main outcome variables
Investigating infection and hematuria caused by double G due to the use and non-use of theophylline along with double G stent placement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190624043991N22
Registration date: 2023-11-19, 1402/08/28
Registration timing: prospective

Last update: 2023-11-19, 1402/08/28
Update count: 0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-31, 1402/11/11
Expected recruitment end date
2025-01-30, 1403/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral theophylline on complications caused by double J: A Double Blind Clinical Trial
Public title
Investigating the effect of oral theophylline on complications caused by double J
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing trans ureteral lithotripsy Patients under the endoscopic ureter For other cases that have a bleeding effect, double G is installed for them. Written and informed consent from patients
Exclusion criteria:
Symptoms of prostatitis/ asthma/ being a smoker Diabetes Gastrointestinal discomfort Insomnia and tremors Taking potassium-sparing diuretics Taking digoxin in patients with heart problems Taking levodopa Taking calcium supplements at the same time/ Taking spironolactone tablets Previous history of hyperkalemia Taking triamterene Taking tablets Amiloride High blood potassium and pregnancy
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a double-blind, randomized clinical trial. The researcher and the participant will not know about the randomization method. For randomization, the balanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the Sealdenvelop online site, the generated sequence will be available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected, and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the group (Double G plus placebo: 30 patients) or (Double G plus theophylline: 30 patients).
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind, randomized clinical trial study. The researcher and the participant will not know how to be placed in the control or intervention groups.The present study is a double-blind, randomized clinical trial study. The researcher and the participant will not know how to be placed in the control group: Double G plus placebo, and the treatment group: Double G plus theophylline.Placebo, a capsule containing sugar resembling a probiotic capsule, is prescribed for 4 weeks.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.007

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
investigating the double J infection brought on by double J stent placement and theophylline usage or non-use
Timepoint
Immediately after leaving double J stent
Method of measurement
Laboratory diagnosis

Secondary outcomes

1

Description
Hematuria after surgery from the operation site
Timepoint
Immediately after surgery
Method of measurement
The number of wet gases

Intervention groups

1

Description
Treatment group, Double G, along with the use of Teolite with the generic name of Theophylline Retard with a dose of 200 mg, Obeidi Pharmaceutical Company, 30 tablets, one daily for one month
Category
Treatment - Drugs

2

Description
Treatment group, double G, and placebo (a capsule containing sugar that looks similar to a probiotic capsule and is prescribed for 4 weeks),Obeidi Pharmaceutical Company
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center - Sina Hospital - Hassan Abad St. - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
http://urc.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
https://URC@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
En Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
En Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
En After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.
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