Etiology and pathogenesis of kidney Stone formation from the Perspective of Persian Medicine and Clinical evaluating of cynodon dactylon and dolichos biflorus extracts on Kidney Stone.
Evaluation of the Effect of Rhizome Extract of Plant and Dactylon Plants on the Removal or Reduction of Kidney Stone Size
Design
96 patients with kidney stones were divided equally and randomly. The method of permutation blocks by software and two unrelated 3 parallel groups of 32 people.
Herbal Medicine Group, Herbal Drug Group and Placebo Group
The placebo group has the usual recommendations and placebo.
Intervention teams will receive herbal medicines for 21 days.
Patients are allowed to use commonly used kidney stone therapy.
Groups are examined in parallel
Settings and conduct
The study is designed at the Mashhad traditional medicine clinic and will be conducted at the clinic of Imam Reza Hospital in Mashhad
Participants/Inclusion and exclusion criteria
Age of 20 to 60 years Renal stone with ultrasound confirmation Kidney stone larger than 5 mm.Satisfaction with the treatment of traditional medicineExit:Pregnancy for women and breastfeedingHistory of chronic kidney diseaseKidney failureMedium or severe hydronephrosis
Intervention groups
To the intervention group, 2 capsules of 800 mg daily containing the extract of rhizome of the plant
And to another group, 2 capsules of 800 milligrams containing the extract of the grapefruit
And to the control group, two capsules containing placebo are given daily
Main outcome variables
Kidney stone size
The amount of kidney stone displacement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043235N1
Registration date:2019-05-08, 1398/02/18
Registration timing:prospective
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Mohammad Azad manjiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 4797
Email address
manjirim1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Etiology and pathogenesis of kidney Stone formation from the Perspective of Persian Medicine and Clinical evaluating of cynodon dactylon and dolichos biflorus extracts on Kidney Stone.
Public title
effect of cynodon dactylon and dolichos biflorus in kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 60 years old
The kidney stone is larger than 5 mm with sonography
satisfaction of traditional treatments.
Lack of history of chronic kidney disease
Exclusion criteria:
Pregnancy for women
Medium to high hydronephrosis
Acute renal diseases such as renal failure
Severe urogenital infection
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation made by Random Allocation software is performed and the number of participants in each group are equal, and then the list of blocks and numbers are assigned to them, and then select random numbers and finally do the list of treatment allocation based on these numbers Is marked as random.
Blinding (investigator's opinion)
Double blinded
Blinding description
People under study and assessors, researcher and watch out for clinical trials of the experimental and control groups will be unaware.This is the same form that drugs and placebo and a similar packaging by an analysis of data available to them in circumstances that placed its content is just a news analysis.
Placebo
Used
Assignment
Parallel
Other design features
In this study the effect of two herbal medicine on kidney stones is done in the event that they are useful as a proof of the effects of a new drug with low side effects, domestic production and commercialization as well as functionality and low cost.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.MUMS.REC.1397.325
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
The size of the Kidney stone and urinary ducts 5 mm and larger than 5 mm
Timepoint
The beginning of the study (before starting the intervention) and 21 days after starting taking cynodon dactylon and dolichos biflorus (Indian mung bean) extract
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Change (reduction) in the size of the stone and move or change the location of the stone (towards the bottom)
Timepoint
21 days after taking cynodon dactylon and Dolichous biflorus extract
Method of measurement
Ultrasound
Intervention groups
1
Description
The seed extract of dolichos biflorus with a dose of 1600 mg (daily 2 capsules 800 mg) will be given for 21 days.
Category
Treatment - Drugs
2
Description
Extracts of cynodon dactylon will be given with a dose of 1600 mg (daily 2 capsules 800 mg) for 21 days.
Category
Treatment - Drugs
3
Description
Control group: Daily 2 capsules of placebo for 21 days are given orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Azad Manjiri
Street address
Imam Reza Sq., Ebne Sina Ave.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of research and technology,Mashhad University of Medical Sciences,Daneshgah street Opposite of Daneshgah street 18
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Azad Manjiri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional medicine and complementary faculty,Ferdowsi University Campus , Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
manjirim1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roshanak Salari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Drug control
Street address
Faculty of Traditional medicine and complementary, Ferdowsi University of Mashhad campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
salariR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Azad Manjiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional medicine and complementary, Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
manjirim1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
If necessary and issuing the necessary license, only a portion of the original outcome information is shared.
When the data will become available and for how long
Depending on the regulations of the university.
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If necessary, researchers working in academic and scientific institutions and licensing required by the university
From where data/document is obtainable
Deputy of Research of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
Send a request to the university vice president of researchCarry out the necessary examinationsProvide a negative or positive result to the applicant