Determining the effect of water extract of Tribulus terestris plant in patients with kidney stones
Design
Clinical trial with a control group, with parallel groups, double-blind, phase 3 on 108 patients. Permuted block randomization sampling method is used to assign samples to treatment groups.
Settings and conduct
This study is conducted on patients with kidney stones referred to the specialized clinic of Qazvin Velayat Hospital. One group is given standard treatment + placebo and the other group is given standard treatment + capsule containing 300 mg of extract of Tribulus terestris (daily half an hour before lunch). Patients will be followed up for two months and at the end of two months they will be examined for the presence or absence of kidney stones using ultrasound.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient age between 20 and 60 years, stone smaller than 6 mm, patient weight between 50 and 100 kg
Exclusion criteria: Urinary tract infection, severe or progressive hydronephrosis
Intervention groups
Intervention group: standard treatment + placebo
Control group: standard treatment + capsules containing 300 mg of extract of Tribulus terestris (daily half an hour before lunch)
Main outcome variables
kidney stone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240308061213N1
Registration date:2024-05-10, 1403/02/21
Registration timing:registered_while_recruiting
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Hosein Jamalodini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
hosseinjamalodini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of water extract of Tribulus terestris plant in patients with kidney stones
Public title
Investigating the effect of Tribulus terestris on kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 20 and 60 years
Stone smaller than 6 mm
Patient weight between 50 and 100 kg
Exclusion criteria:
Unwillingness to participate in the study
Presence of urinary infection
Severe or progressive hydronephrosis
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization is used to assign samples to treatment groups through the website http://www.graphpad.com/quickcalcs/index.cfm. One group is given standard treatment + placebo and the other group is given standard treatment + capsule containing 300 mg of Tribulus terestris extract (daily half an hour before lunch).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to increase the accuracy and accuracy of the study and prevent deviations in the interpretation of the test results, the study is conducted in a double-blind manner, and the participants (patients) and the researcher do not know whether the person received the supplement or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.QUMS.REC.1403.009
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Stone disposal status
Timepoint
Patients will be followed up for two months and at the end of two months they will be examined for the presence or absence of kidney stones using ultrasound.
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Standard treatment + capsule containing 300 mg of Tribulus terestris (daily half an hour before lunch) is given. To prepare Tribulus terrestris extract capsule، first grind the terrestris plant and 50 g of the plant is combined with 1000 ml distilled water. After 24 hours using filter paper، the solution is smoothed. The smoothed solution is placed in a fur temperature of 40°C to dry. The dried extract is then milled and 300 mg of it is poured into the capsule.
Category
Treatment - Drugs
2
Description
Control group: standard treatment + placebo (daily half an hour before lunch) is given. To prepare a placebo, flour is used, and 300 mg of flour is poured into the same capsules of Tribulus terrestris extract.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital clinic
Full name of responsible person
Seyyed Habibollah Jamolodini
Street address
22 Bahman Blvd., Minoodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
hosvelayat@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Habibollah Jamolodini
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
hosseinjamalodini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Habibollah Jamolodini
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
hosseinjamalodini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Habibollah Jamolodini
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
hosseinjamalodini@gmail.com
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