Protocol summary
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Study aim
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Determining the effect of traditional Iranian Medicine (persian medicine) diet recommendations in comparison with Evidence Based diet Recommended by the Stone Prevention Clinic on metabolic risk factors in patients with calcium or radioopaque kidney stones
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Design
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The randomized controlled clinical trial with parallel group single blind designe of 80 patients with calcium or radio opaque kidney stones
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Settings and conduct
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This study is a randomized controlled clinical trial that patients with calcium or radioopacitis, who referred to a stone prevention clinic of Shahid Labbafinejad Hospital who are eligible to attend the study are enrolled. Then, the patients were randomly divided into two groups of control (recipient-based evidence based recommended by the Stone Prevention Clinic) and the intervention group (the recipient of the Iranian traditional medicine regime).
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Participants/Inclusion and exclusion criteria
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Non-pregnant and non-lactating women
Men
People with calcium stone or Patients with Radioopacitis stone in radiology At least once the recurrence of the stone.
Are not under the special regime to prevent kidney stones, At least 20 days have passed since their last treatment interventions.
18 to 65 years old
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Intervention groups
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treatment group: Receiving Dietary Recommendations of Iranian Traditional Medicine to reduce recurrence of kidney stone and improve 24-hour urinary metabolic factors.
control group:Providing evidence-based diet based on international guidelines
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Main outcome variables
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Comparison of the PH value of morning urine, 24-hour urine calcium, magnesium, creatinine, sodium, potassium, chlorine, and citrate in patients with calcium kidney stones or radioopacitis in two groups
Comparison of supersaturation index of calcium oxalate, calcium phosphate and uric acid 24-hour urine in two groups
General information
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Reason for update
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The investigation is over
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190928044906N1
Registration date:
2019-11-11, 1398/08/20
Registration timing:
prospective
Last update:
2021-07-06, 1400/04/15
Update count:
3
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Registration date
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2019-11-11, 1398/08/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-21, 1398/08/30
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Expected recruitment end date
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2021-04-20, 1400/01/31
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Actual recruitment start date
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2019-11-21, 1398/08/30
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Actual recruitment end date
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2021-04-20, 1400/01/31
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Trial completion date
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2021-06-21, 1400/03/31
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Scientific title
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Evaluation the effect of Iranian Traditional Medicine (Persian Medicine) dietary recommendations on metabolic risk factors in calcium or radio-opaque kidney stones: a controlled randomized clinical trial
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Public title
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Effect of persian medicine dietary recommendations in kidney stone
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Non-pregnant and non-lactating women
Men
Patients referred to the Stone Prevention Clinic of Labbafinejad Hospital which can perform tests and follow-up to implement the plan
People with calcium stone or Patients with Radioopacitis stone in radiology
At least once the recurrence of the stone.
Are not under the special regime to prevent kidney stones, At least 20 days have passed since their last treatment interventions.
18 to 65 years old
Exclusion criteria:
GFR less than 60
24-hour urinary oxalate above 40 mg Which changed to over 60mg
Taking drugs affecting calcium metabolism such as calcium supplements
Taking oxalate or supresturation modifier drugs like vitamin B6, magnesium, potassium citrate, allopurinol
liver failure diseases, diabetes, hyperthyroid, hyperparathyroid disease, immunopathogenic diseases, cancer, chronic diarrhea, chronic kidney failure and urinary tract infection
Taking anti-obesity drugs to absorb fat-soluble inhibitors such as: Orlistate
Taking herbal medicines less than a month before studying or during the study
Pregnant and lactating women
Added condition: Do not change the dose of blood pressure medication one month before the plan and during the plan
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
43
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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block randomization. Block randomization with block size of four will be used. Random Allocation software will be used to generate the stochastic sequence. According to the randomly generated sequences, patients enter the control group and the intervention group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-19, 1396/11/30
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1396.1405
Health conditions studied
1
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Description of health condition studied
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Diet in nephrolithiasis
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ICD-10 code
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N20.0
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ICD-10 code description
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Calculus of kidney
Primary outcomes
1
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Description
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24-hour urinary calcium oxalate supersaturation
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Timepoint
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The beginning of the study and the end of the two-month diet
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Method of measurement
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Litorsk Software
2
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Description
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24-hour urinary uric acid supersaturation
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Timepoint
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The beginning of the study and the end of the two-month diet
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Method of measurement
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Litorsk Software
3
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Description
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24-hour urinary calcium phosphate supersaturation
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Timepoint
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The beginning of the study and the end of the two-month diet
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Method of measurement
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Litorsk Software
Secondary outcomes
1
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Description
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Evaluate foods eaten (Food recall)
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Timepoint
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The beginning and the end of the study
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Method of measurement
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Nutrition 4 software
Intervention groups
1
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Description
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Intervention group: Diet based on traditional Iranian medicine books and scientists such as Ibn Sina to control recurrence of stone and improve urinary supersaturation of calcium oxalate and calcium phosphate and uric acid. This diet includes orders to Reforming eating etiquette and improve digestion and orders for non-consumption of harmful foods from the viewpoint of Iranian traditional medicine in kidney stone patients Such as contraindicated yogurt, cheese, and pasta and... etc.
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Category
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Treatment - Other
2
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Description
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Control group: The diet used in Shahid Labbafinejad Medical Center is based on European and American guidlines to control recurrence of stone and improve urinary supersaturation of calcium oxalate and calcium phosphate and uric acid. This regime includes orders such as increasing fluid consumption and eating adequate dairy and reducing salt consumption and ...etc.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research deputy of Shahid Beheshti School of Traditional medicine
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information of the changes in urinary factors of patients will be available without ability to identify patients
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When the data will become available and for how long
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Starting from 2022
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Request the article and oral explanations and guidance by email and academic identity
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From where data/document is obtainable
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Responsible for the research project Dr Reza Ilkhani. ilkhani@sbmu.ac.ir
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What processes are involved for a request to access data/document
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After emailing Dr. Ilkhani on his discretion and confirmation of research assistant of Shahid Beheshti Faculty of Traditional Medicine,the information will be available in less than three weeks.
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Comments
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