Protocol summary
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Study aim
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Evaluation of the effect of Camel milk with Alhagi maurorum Medik on Chronic Kidney Disease
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Design
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This study is a randomized clinical trial
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Settings and conduct
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The total number of 60 patients is taken into account that randomly will be divided into two groups: intervention and control .The control group will receive only routine treatment. The intervention group will receive 400 ml camel milk and syrup 40% of Alhagi maurorum Medik will receive 10 cc per day. The study period is three months .
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Participants/Inclusion and exclusion criteria
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patients with chronic kidney disease at Stage 2-4 with aged 15 to 60 years enter the study.
Patients with chronic kidney disease concomitant uncontrolled diabetes or hypertension, cancer patients, patients with urinary obstruction, the fifth stage of chronic kidney disease , patients with acute infection and feverish, patients who are taking nephrotoxic drugs, patients with heart failure, liver failure, poly cystic kidney, patients who had kidney transplant are excluded.
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Intervention groups
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Intervention group: patients with Chronic Kidney Disease at Stage 2-4 who take commonly used medicines with camel milk and Alhagi maurorum Medik syrup.
Control group:Patients with Chronic Kidney Disease at Stage 2-4 who take commonly used medicines.
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Main outcome variables
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glomerular filtration rate
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016121531427N1
Registration date:
2017-02-25, 1395/12/07
Registration timing:
prospective
Last update:
2018-01-16, 1396/10/26
Update count:
1
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Registration date
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2017-02-25, 1395/12/07
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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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Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-03-05, 1395/12/15
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Expected recruitment end date
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2017-09-21, 1396/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Compare the effects of camel milk with Alhagi maurorum Medik. and current treatments on glomerular filtration rate in patients with chronic kidney disease
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Public title
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The effect of camel milk with Alhagi maurorum Medik on chronic kidney disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients with chronic kidney disease;
aged 15 to 70 years
Exclusion criteria:
Patients with chronic kidney disease concomitant uncontrolled diabetes(Hb A1c less than 9 and fasting blood sugar greater than 130)
Patients with uncontrolled hypertension(systolic blood pressure of 160 mm Hg and higher and diastolic blood pressure of 100 mm Hg and higher)
cancer patients
patients with urinary obstruction
the fifth stage of chronic kidney disease
patients with acute infection and feverish
patients who are taking nephrotoxic drugs
patients with heart failure
liver failure
poly cystic kidney
pregnancy
patients who had kidney transplant
drug addicts
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Age
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From 15 years old to 70 years old
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Gender
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Both
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Phase
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2
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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:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random number table
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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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Randomization will be done with table of random numbers
Ethics committees
1
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Ethics committee
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Approval date
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2016-12-10, 1395/09/20
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Ethics committee reference number
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IR.MUMS.REC.1395.437
Health conditions studied
1
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Description of health condition studied
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Chronic kidney disease, stage 1
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ICD-10 code
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N18.1
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ICD-10 code description
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Kidney damage with normal or increased GFR (> 90 mL/min)
2
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Description of health condition studied
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Chronic kidney disease, stage 2
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ICD-10 code
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N18.2
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ICD-10 code description
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Kidney damage with mild decreased GFR (60-89 mL/min)
3
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Description of health condition studied
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Chronic kidney disease, stage 3
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ICD-10 code
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N18.3
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ICD-10 code description
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Kidney damage with moderately decreased GFR (30-59 mL/min)
4
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Description of health condition studied
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Chronic kidney disease, stage 4
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ICD-10 code
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N18.4
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ICD-10 code description
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Kidney damage with severely decreased GFR (15-29 mL/min)
Primary outcomes
1
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Description
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Glomerular filtration rate
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Timepoint
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Before the intervention, the end of intervention
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Method of measurement
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Cockcroft gault Formula, MDRD
Secondary outcomes
1
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Description
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Hb
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
2
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Description
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Urinary albumin
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Evaluation of urine
3
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Description
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24 hour urine protein level
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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24 hour urine evaluation
4
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Description
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Serum alkaline phosphatase levels
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
5
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Description
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Serum PTH level
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
6
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Description
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Blood uric acid
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Timepoint
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Before the intervention, the end of intervention
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Method of measurement
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Laboratory blood test
7
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Description
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Serum calcium
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
8
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Description
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Serum sodium
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
9
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Description
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Serum potassium
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
10
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Description
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serum CRP levels
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Timepoint
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The beginning of the study, The end of the study
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Method of measurement
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Laboratory blood test
11
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Description
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blood pressure
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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By Sphygmomanometer
12
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Description
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FBS
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Timepoint
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The beginning of the study,Middle of the study, The end of the study
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Method of measurement
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Laboratory blood test
13
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Description
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HbA1C
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
14
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Description
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lipid profile
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Timepoint
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The beginning of the study, the end of the study
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Method of measurement
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Laboratory blood test
15
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Description
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Serum creatinine
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Timepoint
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Before the intervention, the end of intervention
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Method of measurement
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Evaluation of serum
Intervention groups
1
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Description
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The intervention group in addition to routine treatment will receive camel milk a daily dose of 400 ml for three months.
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Category
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Treatment - Other
2
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Description
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The control group will receive the routine Treatments
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Category
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Treatment - Drugs
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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Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
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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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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Laboratory information
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When the data will become available and for how long
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Six months after printing results
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To whom data/document is available
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Researchers working in academia and academia
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Under which criteria data/document could be used
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Researchers working in academia and academia
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From where data/document is obtainable
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tavassolyap1@mums.ac.ir
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What processes are involved for a request to access data/document
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2 months
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Comments
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