Patients will be selected from patients that will be referred to shiraz university of medical sciences clinics and this study will be done at Imam Reza Clinic.
Only the pharmacist knows the contents of the capsules, and the rest of the people include the researcher, the presenter, the patient, the statistician,....are blind.
Participants/Inclusion and exclusion criteria
Have informed and written consent to participate in the study.
Opaque stone greater than or equal to 5 mm and less than or equal to 10 mm.
Age of 18 to 65 years of both sexes.
Male and female.
Satisfaction with the non-use of non-protocol treatments.
In one Last month, there was no effective drug on renal stone.
Not Pregnancy or lactation.
Not sensitization to medications.
Not obstruction or other emergency problem during intervention.
Not organic disease.
Not Kidney transplant or single kidney.
Intervention groups
75 patients with kidney stones will be divided into three groups.
First group will receive 2 capsules containing 1 gram of Lapis judaicus powder daily for two months.
Second group : 2 capsules containing 12.5 mg hydrochlorothiazide +1 gram of Lapis judaicus powder daily for two months.
Third group:
2 capsules containing 12.5 mg hydrochlorothiazide daily for two months.
Main outcome variables
Kidney stone size in sonography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043264N1
Registration date:2019-08-18, 1398/05/27
Registration timing:registered_while_recruiting
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Elham Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 4165
Email address
akbarzadeh_e@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-05, 1398/04/14
Expected recruitment end date
2019-09-05, 1398/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of safety and efficacy of Lapis judaicus versus hydrochlorothiazide in patients with renal stones: a randomized clinical trial.
Public title
Investigating the effect and safety of Lapis judaicus on kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed and written consent to participate in the study.
Opaque stone greater than or equal to 5 mm and less than or equal to 10 mm.
Age of 18 to 65 years of both sexes.Male and female.
Satisfaction with the non-use of non-protocol treatments
In one Last month, there was no effective drug on renal stone.
Exclusion criteria:
Pregnancy or lactation
Sensitization to drugs of intervention
Sensitization to sulfur
Symptoms of digestive, liver or kidney, heart disease · ·
Obstruction or other emergency problem during intervention
Dissatisfaction with the patient to continue the plan for both
Organic disease (kidney, liver, heart disease, cancer, diabetes)
Smoking, alcohol and substance abuse
Coagulopathy disease
Kidney transplant or single kidney.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is block type alog with using random numbers table.
The pharmacist will prepare the three groups of drugs in the same capsule and in the same boxes.The number of boxes is numbered according to the random number and the researcher will randomly give the medicine to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient, the drug delivery officer, physician and the statistical analyst of the result, will be blind, and only the drug manufacture can decode based on the original from of randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
University of Medical Science, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
صندوق پستي1978-71345
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.SUMS.MED.REC.1397.481
Health conditions studied
1
Description of health condition studied
renal stone
ICD-10 code
XIV
ICD-10 code description
XIV Diseases of the genitourinary system
Primary outcomes
1
Description
Renal stone size
Timepoint
2 Months
Method of measurement
KUB Sonography
Secondary outcomes
1
Description
BUN
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
2
Description
Cr
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
3
Description
Calcium
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
4
Description
Aspartate Aminotransferase (AST)
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
5
Description
Alanine Aminotransferas(ALT)
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
6
Description
Urinalysis
Timepoint
Before and after intervention
Method of measurement
refractometry, microscopic and macroscopic urinalysis
7
Description
24- hour urine calcium
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
8
Description
24- hour urine magnesium
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
9
Description
24 -Hour urine citrate
Timepoint
Before and after intervention
Method of measurement
DIRUI Automatic Analyzer
Intervention groups
1
Description
Intervention group A:Two capsules containing Lapis judaicus 1 gram for 2 months .
Category
Treatment - Drugs
2
Description
Intervention group B; Two capsules containing Lapis judaicus 1 gram +12.5 mg of hydrochlorothiazide for 2 months.
Category
Treatment - Drugs
3
Description
Control group C: Two capsules containing 12.5 mg of hydrochlorothiazide for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Shiraz University of Medical Sciences
Full name of responsible person
Elham Akbarzadeh
Street address
Emam Reza Clinic, Zand Ave, Namazi Square
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
dr.akbarzadeh.elham@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yoness Ghasemi
Street address
l, Zand Avenue, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Fax
+98 71 3233 2224
Email
drjaladat@gmail.om
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elham Akbarzadeh
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Department of Traditional Medicine, Shiraz Medical School, Zand Avenue, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Email
akbarzadeh_e@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Akbarzadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Medical Sciences School, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 5145
Email
akbarzadeh_e@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Akbarzadeh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz University of Medical Sciences, Zand, Shiraz, Fars Province,Iran hdای
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
akbarzadeh_e@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Some of the data, such as clinical examination information, renal stone changes, or lab data results, can be shared.
When the data will become available and for how long
Starting 12 months after publication
To whom data/document is available
People working in academic institutions.
Under which criteria data/document could be used
There is not any decision yet.
From where data/document is obtainable
Contact the main researcher
What processes are involved for a request to access data/document
After correspondence with the researcher, within the framework of the declarations and in the shortest possible time.