The effect of topical cream containing zataria multiflora, Pelargonium graveolens and aloe vera gel on size,tissue type and exudate of bedsore on beheshti hospital patients
This double-blind controlled study as a clinical trial on patients with grade 1 and 2 bedsore will be done. Qualified individuals for entry who do not have exclusion criteria use in the project including underlying medical condition, medications and allergies to ingredients, randomly will divide into two groups receiving herbal gel or placebo gel. The two topical products by Barij Essence Company in packaging with the same color and size are made and so patients and physicians won't be aware of the type of medicine. And after completion of the project components will be decoded. So this study will be a double blind study. Duration of study is one month. In these period individuals, 2 times daily after washing with normal saline, use a thin layer of topical components with dressing. At the baseline and end of each week features of Ulcer according to the criteria PUSH will be reviewed. After data collection, the t-test is used to compare groups; also the effect of different parameters is carried out by using analysis of repeated measurements
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072912438N4
Registration date:2013-08-21, 1392/05/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-21, 1392/05/30
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Essence research center of medicinal herbs
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical cream containing zataria multiflora, Pelargonium graveolens and aloe vera gel on size,tissue type and exudate of bedsore on beheshti hospital patients
Public title
Treatment of bedsore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with bedsores Exclusion criteria: cardiovascular diseases, malignancies, end-stage disease - systemic or topical antibiotics - taking glucocorticoids and other local and systemic immunosuppressant drugs - other chronic cutaneous illnesses- sensitivity of herbal products-Desire to withdraw from the study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan university of medical sciences
Street address
Kashan university of medical science, Kashan
City
Kashan
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
1701/1/5/29
Health conditions studied
1
Description of health condition studied
bedsore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Length x Width
Timepoint
end of each week
Method of measurement
greatest lengthx greatest width with ruler
2
Description
exudate amount
Timepoint
end of each week
Method of measurement
observation
3
Description
tissue type
Timepoint
end of each week
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:topical herbal cream- 2 times a day on the bed sore + routine Dressing
Category
Treatment - Drugs
2
Description
control group:topical alfa cream- 2 times a day on the bed sore + routine Dressing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
dr. H.afzali
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence research center of medicinal herbs
Full name of responsible person
miss L.Hejazi
Street address
km44 Kashan, Mashhad Ardehal road.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?