Protocol summary

Study aim
Clinical intervention and evaluation of the effectiveness of oral capsules containing Bonsorkh plant extract in the treatment of oxalate urinary stones. Clinical intervention and evaluation of the effectiveness of oral capsules containing Bosorkh plant extract in the treatment of uric urinary stones
Design
People who meet the inclusion criteria will be randomly assigned to drug and placebo groups. The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3 on 100 patients. Simple block method was used for randomization.
Settings and conduct
Patients will be selected from the Nephrology of Al-Zahra Hospital (S), Noor and Ali Asghar, Isfahan. For people in the drug group, a capsule containing 500 mg of hydroalcoholic extract will be given three times a day, and for people in the placebo group, a placebo will be given. The participants, physicians and medical personnel who are responsible for the examination and care of the patients, those responsible for data collection and those who evaluate the outcome, were kept blinded to the study groups in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria Urinary tract stones Not having a structural disorder of the urinary tract or a urinary tract infection. No gout or hyperuricemia Exclusion criteria Need to be hospitalized need for lithotripsy UTI
Intervention groups
- Receiving the Bonsorkh plant for the oxalate urinary stones - Receiving the Bonsorkh plant for the uric urinary stones - Receiving the placebo for oxalate urinary stones - Receiving the placebo for uric urinary stones
Main outcome variables
Preparation of oral capsule containing bonsorkh plant extract, clinical investigation of bonsorkh formulation in improving renal function of patients with oxalate urinary stones, clinical review of bonsorkh formulation in improving renal function of patients with uric urinary stones.

General information

Reason for update
Acronym
AKS
IRCT registration information
IRCT registration number: IRCT20240712062398N1
Registration date: 2024-07-20, 1403/04/30
Registration timing: prospective

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Mustafa Ghanadian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 2451
Email address
ghannadian@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An effective herbal formulation of the Allium jesdianum based on Iranian traditional medicine along with its human clinical trial on improving the kidney function in patients suffering from oxalate, or uric kidney stones.
Public title
A human clinical trial of an Allium jesdianum formulation on kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic or asymptomatic urinary tract stones Stone size equal to 10 mm or less Absence of malignancy with bone metastasis Not suffering from hyperthyroidism, hyperparathyroidism, psychosis or kidney dysfunction (creatinine above 1.4 mg/dL) Not having a structural disorder of the urinary tract or a urinary tract infection No gout or hyperuricemia Not using other traditional products and complementary medicine used in the treatment of urinary stones from one week before the intervention Absence of pregnancy and breastfeeding
Exclusion criteria:
Non-compliance with medication orders for more than 1 week Allergy to any component of the herbal product The need for hospitalization due to the severity of symptoms during the study The need for surgery and lithotripsy during the study Urinary tract infection during the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, physicians and medical personnel who are responsible for the examination and care of the patients, those responsible for data collection and those who evaluate the outcome, were kept blinded to the study groups in the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazarjarib St
City
Isfahan
Province
Isfehan
Postal code
81746 – 73461
Approval date
2024-07-07, 1403/04/17
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.042

Health conditions studied

1

Description of health condition studied
Oxalate urinary stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
The percentage of stone size change
Timepoint
Before and after the intervention
Method of measurement
with ultrasound based on millimeter units

2

Description
Concentration of calcium, sodium, citrate, oxalate, urea, creatinine, uric acid and cystine, phosphorus in urine
Timepoint
Before and after the intervention
Method of measurement
mg/dl

3

Description
Number of people with stone removal
Timepoint
Before and after the intervention
Method of measurement
number

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with oxalate kidney stones
Category
Treatment - Drugs

2

Description
Intervention group: Patients with uric kidney stones
Category
Treatment - Drugs

3

Description
Control group: patients with oxalate kidney stones
Category
Placebo

4

Description
Control group: Patients with uric kidney stones
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor and Ali Asghar Hospital in Isfahan
Full name of responsible person
Dr. Mozhgan Mortazavi
Street address
Ostandary St., Hasht Behesht St.
City
Isfahan
Province
Isfehan
Postal code
81746 – 73461
Phone
+98 913 316 7326
Email
mortazavi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hazarjarib St., University of Medical Sciences, Research Vice-Chancellor
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3138
Email
intres@mui.ac.ir
Grant name
Grant code / Reference number
140374
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool soltani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
81746 – 73461
Phone
+98 31 3792 0001
Email
soltani@pharm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mustafa Ghnadian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
pharmacognosy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
81746 – 73461
Phone
+98 31 3792 0025
Email
Ghannadian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mustafa Ghanadian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Pharmacy
City
Isfahan
Province
Isfehan
Postal code
81746 – 73461
Phone
+98 31 3792 0025
Email
Ghannadian@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
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