This study is designed to determine dissolving Effects of prepared drug based on Caltrop on Renal Stones. The prepared drug and placebo will given to the patients with age between 18-60 and size of stone between 6-10 millimeter recognized by valid diagnostic tests. The primary outcome will be assessed by changing in stone size. At the term of study data gathered will analyzed by applying valid and reliable statistical tests
Design
For patients of this study, kidney and liver tests that will be done, there is asked to make CT-scan or sonography without any contrast from all of participants and then each patient will be put in one of intervention or placebo groups randomly. Drug or placebo that have been prepared as syrup will be individualized them among two months to take twice a day by 10 cc. The 1st and 2nd follow ups will be after 2nd week and so after 4th week by calling on, 3rd and 4th follow up will be after 6th and 8th week by interviews. In the last session in addition of visit, there will be studies on liver and kidney exams, sonography and CT-scan if required.
Settings and conduct
All participants will be visited by urologist and refer to researcher in the urology clinic of Hamadan Beheshti hospital.
Participants/Inclusion and exclusion criteria
Agreement of participant, the size of renal stones: between 6-10 mm, the number of stones: 1-3mm, the location of the stones: superior, middle and inferior calyxes, age between 18-60, normal renal and liver function test.
Intervention groups
Volunteer patients will receive 10cc caltrop , two times a day, for 2 month.
Main outcome variables
Checking of stones size; displacement or change of stones; excretion of kidney stones.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221225056918N1
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Hediyeh Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3277 4834
Email address
h.amin@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of caltrop (Tribulus terristris) aqueous extract on 6-10 mm renal stones: a double blind randomized clinical trial
Public title
The effect of caltrop extract on renal stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Renal stones between 6-10 mm (kidney sonography or spiral CT without contrast)
Renal stones without simultaneous symptoms ( uncontrollable pain and nausea and vomiting ) or referral pain
Number of stones: between 1-3 stones
The stones localize upper, middle and lower calyxes
Agreement of participant to inform consent and signing itʼs written form before recruiting in the study.
Age of participant between 18-60 yr both gender
The participant don't use other herbal or chemical drugs that effect on renal stones (allopurinol, indinavir, ).
Normal LFT (SGOT,SGPT, Alkaline Phosphatase), Normal KFT(BUN, Cr)
Exclusion criteria:
Consumption other types of chemical or herbal drugs except those prescribed in this study;
History of significant problems (diabetes mellitus, renal dysfunctions, hepatic dysfunctions and peptic ulcer)
other procedures or emergency interventions
Affecting by urinary stone complications (any grade of hydro-nephrosis and urinary tract infectious)
Subjects intending to withdraw at any time during the course of study
Pregnancy; Lactating
sensitivity to Caltrop
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will do in the intervention and control groups by blocking method. Using the Excel sheet, we generated 32 group with the block size of 2 people in each. Finally, we use the "Random" command to calculate the probability for each group. By sorting the probability, we will select 64 people, each allocate to intervention or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researchers are kept blind. Each patient will receive a sealed envelop containing the relevant code for the type of intervention. Patients will be prescribed to receive whether A or B pack. Therefore, although, the pharmacologist is not blind, the radiologist and other researchers from medical school will be blind. In addition, as both groups will receive medication, they are not aware of whether they have receive the placebo or new treatment.
Placebo
Used
Assignment
Parallel
Other design features
The study population includes 64 patient with kidney stone disease (stone size between 6-10 millimeters). Patients will be divided into control and intervention group by chance (32 patients in each group). The study is a double blind randomized clinical trial during 8 weeks. Initially the size and position of stones will be obtained by sonography or CT-Scan. At the end of study, sonography or CT-scan will be repeated. The results of examining size, number and location of stones in two groups will be compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan medical university
Street address
Shahid fahmideh Ave., Pajoohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.UMSHA.REC.1401.838
Health conditions studied
1
Description of health condition studied
urolithiasis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Size of renal stones
Timepoint
Before intervention and two months after intervention
Method of measurement
Sonography or CT-scan without contrast
2
Description
Location of renal stones
Timepoint
Before inter vention and two months after intervention
Method of measurement
Sonography or CT-scan without contrast
3
Description
Number of stones
Timepoint
Before inter vention and two months after intervention
Method of measurement
Sonography or CT-scan without contrast
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Volunteers will take 10cc of caltrop syrup twice a day during two months.
Category
Treatment - Drugs
2
Description
Control group: Volunteers will take 10cc of placebo syrup twice a day during two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic of Shahid Beheshti hospital
Full name of responsible person
Hedyeh Amin
Street address
Shahid Beheshti hospital, No1, Eram Blvd., Ghaem Sq.
City
Hamedan
Province
Hamadan
Postal code
5337165179
Phone
+98 81 3838 0703
Email
hedyeh.amin68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Shahid fahmideh Blvd., Pajoohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 4058
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Biglarkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid fahmideh Blvd., Pajoohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
mahdibiglarkhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Biglarkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Fahmideh Blvd., Pajoohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
mahdibiglarkhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Biglarkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Fahmideh Blvd., Pajoohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
009831310000
Email
mahdibiglarkhani@gmail.com
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
Undecided - It is not yet known if there will be 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