To evaluate the effect of a Traditional Persian Medicine product, composed of Sweet Almond and Plantago seed, on Proteinuria in patients with Diabetic Nephropathy.
Nephropathy is albuminuria and decreased (GFR) in diabetic patients The effect of sweet almonds and plantago in proteinuria has been proved separately in scientific studies .this study is designed to investigate the role of this compound in progression and control of this complication.
Design
The clinical trial will be conducted with one intervention group and one control group, randomized blocked, sample size of 60, followed for two months.
Settings and conduct
After approving the project & registering the study on the site and obtaining the clinical trial code, the research will be conducted in Dr. Saghafi Clinic of kidney subspecialty in Shahid Beheshti Hospital in Qom.
This study is a randomized clinical trial with two groups of intervention and control. Patients with diabetic nephropathy are evaluated by a renal subspecialty and according to the inclusion criteria, eligible patients will be selected from among them. After selecting a sufficient number of patients, they will be divided into the intervention group and one control group by random allocation method.
Participants/Inclusion and exclusion criteria
Entry criteria: Informed consent. Excretion of albumin between 30-300 mg in 24-hour urine.Blood pressure less than 160 mmHg.HbA1C between 7 and 9%.
Exclusion criteria: Complications. Increase proteinuria.Drug allergy
Intervention groups
Patients will be randomly divided into two groups of 30 patients. The duration is two months.
1st group will be given Losartan 25 mg twice a day every 12 hours. (8am/8pm or any other time other than the time of use of traditional medicine products)
2nd group will be given Losartan 25 mg twice a day every 12 hours plus traditional medicine product (10 grams sachet) twice a day two hours after breakfast and two hours after lunch along with a little water.
Main outcome variables
Decreased or no Proteinuria in patients with Diabetic Nephropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221015056179N1
Registration date:2022-10-17, 1401/07/25
Registration timing:prospective
Last update:2022-10-17, 1401/07/25
Update count:0
Registration date
2022-10-17, 1401/07/25
Registrant information
Name
Romella Haider
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3294 3187
Email address
rheidar@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-05, 1401/08/14
Expected recruitment end date
2023-11-05, 1402/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of a Traditional Persian Medicine product, composed of Sweet Almond and Plantago seed, on Proteinuria in patients with Diabetic Nephropathy.
Public title
To evaluate the effect of Sweet Almond and Plantago seed, on Proteinuria in patients with Diabetic Nephropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to enter the project
People aged 30 to 70 years
No kidney failure or any other disease that leads to diabetic nephropathy
No symptoms of urinary tract infection during study
Not taking anticoagulants, corticosteroids
Excretion of albumin between 30-300 mg in 24-hour urine
Blood pressure less than 160 mmHg
Potassium less than 5.8 mA/L
GFR more than 60 ml per minute per 1.73 m3 body
Creatinine less than 2 mg/dl
No professional athletes
Not having Chronic neurological disease (severe depression and anxiety)
Non-pregnancy and lactation
SGPT rate less than three times normal before study (below 100 units per liter)
HbA1C between 7 and 9%
No urinary tract infection and kidney ducts.
Exclusion criteria:
Causing any complications
Dissatisfaction with follow-up treatment
Increase proteinuria
Drug allergy
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to two groups is done using random block allocation method using 4 and 6 blocks. Block sequences are assigned to groups using specified software and patients are assigned to groups based on the determined sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Specialized Committee on Ethics in Biomedical Research
Other specified diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Decreased Proteinuria in urine
Timepoint
At the beginning of the study (before the intervention) and on days 30 after the intervention
Method of measurement
UA Urinary Protein
2
Description
Decreased Proteinuria in 24 hour Urinary protein
Timepoint
At the beginning of the study (before the intervention) and on day 60 after the intervention
Method of measurement
24 hour Urinary Protein
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:This group will be given Losartan 25 mg twice a day every 12 hours as well as traditional medicine product (10 grams sachet) twice a day two hours after breakfast and two hours after lunch along with a little water.
Category
Treatment - Drugs
2
Description
Control group: This group will be given Losartan 25 mg twice a day to be given one every 12 hours. (8am/8pm or any other time other than the time of use of traditional medicine products)