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Effect of Grape seed oil (Grapex) on wound healing in patients with scleroderma

Protocol summary

Study aim
The effect of grape seed oil (Grapex) in wound healing of scleroderma patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. Excel software rand function was used for randomization.
Settings and conduct
The present study was a double-blind clinical trial on scleroderma patients referred to the rheumatology clinic of Golestan hospital in Ahvaz. The patients, the intervener, and the person reviewing the results did not know what group the individuals were in, and the study was double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: presence of at least one active wound due to scleroderma (diffuse / limited), age 20 to 70 years, patients' consent. Exclusion criteria: Allergy (including allergy to grapes and their compounds), the presence of comorbidities including diabetes, thyroid disorders, and cardiovascular disease, addiction to alcohol or drugs, smoking, intake of prostanoids (any form) at least in the last 3 months, receiving antibiotics 2 weeks before the start of the study, moderate to severe liver disorders or increased aminotransferase levels more than 3 times, the presence of any type of malignancy, pregnancy and lactation, unwillingness to participate in the study
Intervention groups
Intervention group: Grapex 2% cream prepared from the School of Pharmacy was used twice a day for 4 weeks on the surface of their wounds. Control group: The second group of placebo (cream with similar composition except the main ingredient, ie grape seed extract prepared from Ahwaz School of Pharmacy) was given with the same duration of the intervention group
Main outcome variables
Wound size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201010048984N1
Registration date: 2020-10-23, 1399/08/02
Registration timing: retrospective

Last update: 2020-10-23, 1399/08/02
Update count: 0
Registration date
2020-10-23, 1399/08/02
Registrant information
Name
Marya. ghanavati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 8670 5503
Email address
maryam.ghanavati2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-07-25, 1399/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Grape seed oil (Grapex) on wound healing in patients with scleroderma
Public title
Effect of Grape seed oil (Grapex) on scleroderma wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of at least one active wound due to scleroderma (diffuse / limited) Age 20 to 70 years Patient satisfaction
Exclusion criteria:
Existence of allergy and sensitivity to grapes and their compounds, Existence of comorbidities including diabetes, thyroid disorders, and cardiovascular disease Addiction to alcohol, cigarettes and any drugs Getting prostanoids (both inhaled and taken) for at least the last 3 months Take antibiotics 2 weeks before the start of the study Moderate to severe hepatic impairment or elevated aminotransferase levels more than 3 Existence of any kind of malignancy Pregnancy and lactation Reluctance to participate in the study
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the interventionist and the person examining the results did not know what group the individuals were in, and the study was double-blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS)
Street address
Khuzestan Province, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.AJUMS.REC.1397.948

Health conditions studied

1

Description of health condition studied
scleroderma
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]

Primary outcomes

1

Description
Wound size
Timepoint
Every 2 weeks (end of the second week and the fourth week)
Method of measurement
Wound ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Grapex 2% cream prepared from the School of Pharmacy was used twice a day for 4 weeks on the surface of the wounds.
Category
Treatment - Drugs

2

Description
Control group: The second group of placebo (cream with similar composition except the main ingredient, ie grape seed extract prepared from Ahwaz School of Pharmacy) was given with the same duration of the intervention group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Clinic of Golestan Hospital, Ahvaz
Full name of responsible person
Maryam Ghanavati
Street address
Ahvaz, Farvardin Blvd., Golestan hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Golestanjpsital@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Info@Ajums.Ac.Ir
Grant name
Ahvaz Jundishapur University of Medical Sciences
Grant code / Reference number
MPRC-9731
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Ghanavati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Maryam.ghanavati2020@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Ghanavati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Maryam.ghanavati2020@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Ghanavati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
Maryam.ghanavati2020@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be a plan to make this available
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