The effect of immature grape juice in the treatment of proteinuria in membranous nephropathy or focal and segmental primary glomerulosclerosis
Design
Clinical trial, randomization with Rand excel software, double-blind,
Patients and interveners are unaware of the type of intervention performed for each group
Settings and conduct
Among patients with membranous nephropathy or primary focal and segmental glomerulosclerosis referred to Imam Reza Hospital of Tabriz University of Medical Sciences, 60 patients (30 patients in the intervention and 30 in the control group) were randomly selected and the cans containing unripe grape juice sachets and placebo were coded as A and B by a person other than the researcher. The intervention group will receive one sachet containing 6.3 grams of powder of the mentioned formulation before breakfast and the control group received 6.3 grams of placebo daily for 2 months
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with membranous nephropathy or primary focal and segmental glomerulosclerosis
Exclusion criterias : pregnancy; lactation; Patients with concomitant disease
Intervention groups
Among patients with membranous nephropathy or primary focal and segmental glomerulosclerosis referred to Imam Reza Hospital of Tabriz University of Medical Sciences, 60 patients are assigned to one of the two intervention and control groups (30 people in each group).
Main outcome variables
Proteinuria is one of the major problems of patients with membranous glomerulopathy, in which treatment with various drugs might lead to inadequate response and even a refractory situation. in case of successful results using this intervention, which also has long been utilized as a food and seasoning agent, a significant improvement of protienuria can achieved and the patient's need for drugs with deleterious side effects can be reduced.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211206053292N1
Registration date:2021-12-28, 1400/10/07
Registration timing:prospective
Last update:2021-12-28, 1400/10/07
Update count:0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
Fariba Mahmoodpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
mahmoodpoorfa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of unripe grape juice in the treatment of proteinuria: A randomized placebo-controlled clinical trial
Public title
The effect of unripe grape juice in the treatment of proteinuria: A randomized placebo-controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Membrane nephropathy or primary focal and segmental glomerulosclerosis
Willingness to collaborate in the study in patients
Age range 64-18 years
Exclusion criteria:
kidney Transplantation
pregnancy
lactation
Allergy or Asthma and other Allergies
herbal drug consumption from three months ago
addiction, Cigarettes, Alcohol and Shisha using
professional sport
diseases : chronic inflammatory disease (like Rheumatoid Arthritis ), Major Depression, Schizophrenia, Severe liver disease, cirrhosis, malignancies, severe infectious disease
Age
From 18 years old to 64 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method that will be done using a random number table and even numbers will be considered for one group and odd numbers will be assigned to another group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, at the beginning of the study, the set of cans containing unripe grape juice sachets and placebo is coded as A and B by someone other than the researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
kidney research center,Emam reza Hospital, Golgasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.TBZMED.REC.1400.781
Health conditions studied
1
Description of health condition studied
Membranous Nephropathy
ICD-10 code
N05.2
ICD-10 code description
Unspecified nephritic syndrome with focal and segmental glomerular lesions
Primary outcomes
1
Description
24-hour protein content of urine
Timepoint
Before the intervention and 8 weeks after the start of the intervention
Method of measurement
Calorimeteri
Secondary outcomes
1
Description
Serum albumin content
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Measurements in the laboratory with standard materials and devices by the calorimetri method
Intervention groups
1
Description
Intervention group: in addition to the usual drug treatment, a bag of unripe grape juice (containing 6.3 grams of unripe grape juice powder) will be prescribed daily before breakfast for 2 months.
Category
Treatment - Drugs
2
Description
Control group: This group will receive the usual drug treatment along with a placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital(Tabriz)
Full name of responsible person
Dr. Mohammadreza Ardalan
Street address
Emam Reza Hospital, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Golghasht street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
DR.Mohammadreza Ardalan
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emamreza Hospital, Golghasht Street.Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Ardalan
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emamreza Hospital, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
009833369331
Email
ardalan34@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not 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
Not applicable
Title and more details about the data/document
At the request of other researchers, the requested information will be provided to them
When the data will become available and for how long
Start high access immediately after publishing and printing study results
To whom data/document is available
Academic and industrial researchers
Under which criteria data/document could be used
Trust and do not change the results
From where data/document is obtainable
Dr. Mohammad Reza Arlan
Preferably via email ardalan34@yahoo.com
What processes are involved for a request to access data/document
Send a request by email stating the reason for requesting the information and where and for what purpose it will be used.