Investigating the effect of aqueous extract of Tribullus fruit on the size of kidney stones and urinary metabolic parameters of patients
Comparison of drug side effects including (average liver enzymes, headache, dizziness, nausea, itching, blood pressure) in the studied groups
Comparison of the number of diclofenac tablets used for pain control in the intervention and control groups
Design
Example 2: Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Urology Clinic of Razi Birjand Hospital affiliated to University of Medical Sciences
.
Participants/Inclusion and exclusion criteria
Age 18-60 years
Kidney stones with a size of 4-10 mm in the upper, middle, lower calyces and pelvis
In terms of clinical signs and symptoms, kidney stones are either asymptomatic or accompanied by local pain or shooting pain to other areas that can be controlled with non-steroidal pain medications (diclofenac 100 mg/bid).
Not using any kind of chemical and herbal medicine to treat kidney stones, except for those prescribed in this research
The patient is willing to enter the study;Having high blood pressure
Having diabetes
Suffering from acute and chronic kidney failure
Cancer or immune system deficiency
pregnancy
breastfeeding
BMI above 30
The patient is in emergency condition (renal colic).
Intervention groups
The studied medicinal plant is kharkhasek plant, which is used in the form of capsules containing the dry extract of the plant with a dose of 700 mg daily, three times in the morning, noon and night for 8 weeks.
Main outcome variables
kidney stone size; Urine volume and urine metabolites including calcium, oxalate, citrate, uric acid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240513061783N1
Registration date:2024-06-20, 1403/03/31
Registration timing:registered_while_recruiting
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Zahra Badiazim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3245 2492
Email address
zahra.badiazim@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the aqueous extract of Tribulus terrestris on the kidney stone size and urine metabolic evaluation of the patients
Public title
The effect ofTribulus on kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having kidney stones
Exclusion criteria:
The emergency phase of renal colic
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, blockParallel and controlled randomization. Participants are entered using random_block allocation of four. Patients, attending physicians and radiologists are blinded to group allocation. Medicine and placebo are distinguished by completely similar packaging with labels A and B. The random number of participants is administered using computer generated numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
After preparation of drug and placebo by the esteemed co-researcher specialized in traditional medicine pharmacy, drug and placebo capsules will be allocated to two groups based on random blocks of four. In order to eliminate the confounding effect of age (under 40 and over 40) and gender, random blocks will be set based on these variables. In this study, the researcher, the patient, and the statistical analyst are blinded to which drug and which drug is the placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Commities of Birjand university of Medical Sciences
Street address
ghafari street, south khorasan,Birjand university of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.BUMS.REC.1403.038
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
kidney stone size
Timepoint
Measurement of kidney stone size at the beginning of the study and 8 weeks after the start of the intervention (end of the intervention)
Method of measurement
ultra sonography
Secondary outcomes
1
Description
urine metabolic evaluation
Timepoint
The beginning of the study and 8 weeks after the start of the intervention
Method of measurement
24-hour urine collection
Intervention groups
1
Description
Intervention group: Tribullus capsule 700 mg daily divided into three doses every 8 hours, two capsules prepared by Dr. Zarghani Pearl Farm Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Razi Birjand Hospital affiliated to University of Medical Sciences
Full name of responsible person
Seyyedah Fatemeh Askari
Street address
Ghaffari Street, University of Medical Sciences, Department of Iranian Traditional Medicine
City
Birgand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
sfaskari98@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Masoud yousefi
Street address
Ghafari, Birjand University of Medical Sciences, Department of Traditional Iranian Medicine
City
Birgand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5696
Email
Zahra.badiazim@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zahra Badiazim
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Ghaffari Street, University of Medical Sciences, Department of Iranian Traditional Medicine
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Email
Zahrabadiazim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyedah Fatemeh Askari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaffari Street, University of Medical Sciences, Department of Iranian Traditional Medicine
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5696
Email
sfaskari98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Badiazim
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Ghaffari Street, University of Medical Sciences, Department of Iranian Traditional Medicine
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5696
Email
Zahra.badiazim@bums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available