Improvement in weight indices; cachexia and laboratory indices after using herbal extracts (Punica Granatum) syrup
Design
A concealed, randomized, not blinded, sham-controlled clinical trial with a parallel-group design of 60 patients, block randomization was used for randomization.
Settings and conduct
Determining 30 persons for control group and 30 for consumer group, 5ml three times a day before food for at least 2 months, checking the patient's acceptance during the study, recording the patient's demographic information, measuring the patient's weight with scale at the beginning, one and two months after the start of treatment and measuring other indicators according to laboratory standards.
Participants/Inclusion and exclusion criteria
Inclusion criteria: satisfaction with participating in the study; age over 18 years old; serum albumin levels less than 3.2 g/l and at least 3 months of peritoneal dialysis has passed in cachexic person. Exclusion criteria: intolerance to syrup; kidney transplantation;, death.
Intervention groups
Syrup, manufactured by Barij Essance Co., Iran; dose is 5 ml three times a day, before each meal for at least two months. Patient monitoring during the study to ensure adherence to treatment.
Main outcome variables
Improvement of weight indices; cachexia and laboratory indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160713028901N3
Registration date:2020-10-20, 1399/07/29
Registration timing:prospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Shirinsadat Badri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7068
Email address
badri@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of herbal extracts (Punica Granatum) on weight and cachexia indices in peritoneal dialysis patients
Public title
Effect of herbal extracts on weight and cachexia indices in peritoneal dialysis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with participation in the study
Age over 18 years old
Albumin levels less than 3.2 g/l
At least 3 months have passed since peritoneal dialysis and they have now been diagnosed with cachexia
Exclusion criteria:
Syrup intolerance
Kidney transplantation
Death
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: Blocks of 4 will be used and patients will be assigned to drug and control groups based on the determined sequences in the blocks.
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
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar-Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.MUI.MED.REC.1399.431
Health conditions studied
1
Description of health condition studied
Peritoneal dialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Weight indices
Timepoint
Before the start and at the end of first month and second month
Method of measurement
Body analyzer device and Strip meter
2
Description
Cachexia
Timepoint
Before the start and at the end of first month and second month
Method of measurement
Visual Analog Scale questionnaire
3
Description
Serum albumin
Timepoint
Before the start and at the end of second month
Method of measurement
Elisa
4
Description
Serum triglyceride
Timepoint
Before the start and at the end of second month
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: consuming herbal extracts (Punica Granatum)Syrup, manufactured by Barij Essance Co., Iran; dose is 5 ml three times a day, before each meal for at least two months. Patient monitoring during the study to ensure adherence to treatment.
Category
Treatment - Drugs
2
Description
Control group: Peritoneal dialysis patients that received neither intervention drug nor placebo drug
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Shirinsadat Badri
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Vice Chancellery of Research, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Sofe Ave. Isfahan Kidney Diseases Research Center, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7068
Email
badri@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jarib, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 3792 7068
Email
badri@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jarib street, Isfahan, iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7069
Email
badri@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD