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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General information
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43
43
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2019-11-21, 1398/08/30
2019-11-21 00:00:00
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2021-04-20, 1400/01/31
2021-04-20 00:00:00
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2021-06-21, 1400/03/31
2021-06-21 00:00:00
With the expertise of specialists and professors of traditional medicine and urologists and nutrition, corrections are made in the inclusion and exclusion criteria.
The investigation is over
With the expertise of specialists and professors of traditional medicine and urologists and nutrition, corrections are made in the inclusion and exclusion criteria.The investigation is over
با نظر کارشناسی متخصصان و اساتید طب سنتی و ارولوژیست و تغذیه، اصلاحاتی در کرایتریای ورودی خروجی انجام میگیرد.
طرح پایان پذیرفت.
با نظر کارشناسی متخصصان و اساتید طب سنتی و ارولوژیست و تغذیه، اصلاحاتی در کرایتریای ورودی خروجی انجام میگیردطرح پایان پذیرفت.
Protocol summary
Study aim
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
Design
The randomized controlled clinical trial with parallel group single blind designe of 80 patients with calcium or radio opaque kidney stones
Settings and conduct
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).
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
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
Reason for update
The investigation is over
Acronym
IRCT registration information
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
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Fatemeh Kargarsharifabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
f.kargarsharif@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
2019-11-21, 1398/08/30
Actual recruitment end date
2021-04-20, 1400/01/31
Trial completion date
2021-06-21, 1400/03/31
Scientific title
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
Public title
Effect of persian medicine dietary recommendations in kidney stone
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
The beginning of the study and the end of the two-month diet
Method of measurement
Litorsk Software
2
Description
24-hour urinary uric acid supersaturation
Timepoint
The beginning of the study and the end of the two-month diet
Method of measurement
Litorsk Software
3
Description
24-hour urinary calcium phosphate supersaturation
Timepoint
The beginning of the study and the end of the two-month diet
Method of measurement
Litorsk Software
Secondary outcomes
1
Description
Evaluate foods eaten (Food recall)
Timepoint
The beginning and the end of the study
Method of measurement
Nutrition 4 software
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Prevention Clinic of Shahid Labafi Nejad Hospital
Full name of responsible person
Reza Ilkhani
Street address
No. 8, Shams Alley, Valie Asr
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
ilkhanir@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Shahid Beheshti School of Traditional medicine
Full name of responsible person
Reza Ilkhani
Street address
Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
f.kargarsharif@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Shahid Beheshti School of Traditional medicine
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Kargarsharif
Position
phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
f.kargarsharif@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
ilkhanir@sbmu.ac.ir
Web page address
http://traditonal.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Beheshti School of Traditional medicine, No. 8, Shams Alley, Valie Asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
ilkhanir@sbmu.ac.ir
Web page address
http://traditional.sbmu.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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Information of the changes in urinary factors of patients will be available without ability to identify patients
When the data will become available and for how long
Starting from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request the article and oral explanations and guidance by email and academic identity
From where data/document is obtainable
Responsible for the research project Dr Reza Ilkhani. ilkhani@sbmu.ac.ir
What processes are involved for a request to access data/document
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.