1. Home
  2. Approved trials
  3. » فارسی

Assessment of the Effect of Local Scrophularia Striata Solotion on Healing of Peristomal Wound in Patients Referring to Tehran Ostomi Assosiation

Protocol summary

Study aim
Determining the effect of local solution of Scrophularia Striata on the rate of wound healing around the ostomy in patients referred to the ostomy association
Design
The clinical trial has a control group and an intervention group in parallel, without blinding, the sampling method is done in two stages. In the first stage, the samples are studied by the available method. In the second stage, the samples will be randomly assigned to two groups. Randomization will be done using Excel software and the rand command
Settings and conduct
Sampling will be done in the Iranian Ostomy Association. After sampling and randomization, first, the information form related to demographic and clinical characteristics was collected, and then in both control and test groups, the skin around the ostomy was first checked using the ostomy examination tool. The intervention should be carried out for 14 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: Not using drugs that affect the wound, such as corticosteroids, anti-inflammatory steroids Absence of infection symptoms such as fever, discharge No need for surgery and wound healing Not suffering from skin diseases such as lupus, psoriasis, dermatitis No radiotherapy or chemotherapy in the last 4 months The age of the participants is over 18 years Insensitivity to the Scrophularia Striata plant exclusioncriteria : Need for emergency surgery
Intervention groups
The patients of the intervention group are taught to apply the local solution of thirst-quenching plant at a specified time using an applicator to the skin around the stoma and repeat this every day for 14 consecutive days. And in the control group, he receives the usual training of the ostomy center (use of chamomile ointment).
Main outcome variables
intensity of color change, amount of tissue damage to the dermis and epidermis, tissue overgrowth (granulation)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230510058145N1
Registration date: 2023-06-06, 1402/03/16
Registration timing: registered_while_recruiting

Last update: 2023-06-06, 1402/03/16
Update count: 0
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
kimia miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
kimiamiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of Local Scrophularia Striata Solotion on Healing of Peristomal Wound in Patients Referring to Tehran Ostomi Assosiation
Public title
Assessment of the Effect of Local Scrophularia Striata Solotion on Healing of Peristomal Wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not using drugs that affect the wound, such as corticosteroids, anti-inflammatory steroids Absence of infection symptoms such as fever, discharge No need for surgery and wound healing Not suffering from skin diseases such as lupus, psoriasis, dermatitis Insensitivity to the Scrophularia Striata plant No radiotherapy or chemotherapy in the last 4 months
Exclusion criteria:
The use of drugs effective on wounds such as corticosteroids, anti-inflammatory steroids Having symptoms of infection such as fever, discharge The need for surgery and wound healing Suffering from skin diseases such as lupus, psoriasis, dermatitis Allergy to the Scrophularia Striata plant History of radiotherapy or chemotherapy in the last 4 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method takes place in two stages. In the first stage, the samples are entered into the study in the accessible(continuous) method. In the second stage, the samples will be randomly assigned to two control and test groups. Randomization will be done using Excel software and the rand command.
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
Ethics committee in research of School of pharmacy, nursing & midwifery , Shahid Beheshti Universi
Street address
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-04-25, 1402/02/05
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.008

Health conditions studied

1

Description of health condition studied
peristomal skin complications
ICD-10 code
K91.4
ICD-10 code description
Colostomy and enterostomy malfunction

Primary outcomes

1

Description
on Healing of Peristomal Wound Using the ostomy skin tool
Timepoint
The skin around the stoma will be examined on days 3, 7, 14 and 21 of treatment
Method of measurement
ostomy skin tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group are taught that after cleaning the skin around the stoma with water, apply the local solution of Local Scrophularia Striata provided to them at a specified time using an applicator on the skin around the stoma, and this Repeat the work every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp. (The preparation of the solution is that theLocal Scrophularia Striata collected in dry shade and after the plant extract is powdered with hydroalcoholic solvent (70%) is prepared by the maceration method for 72 hours. Then, the solution is passed through a strainer and If necessary, the solvent will be removed, the obtained solution will be poured into sterile containers and will be provided to the patient for topical use.
Category
Treatment - Drugs

2

Description
Control group: Patients in the control group are taught to apply the chamomile ointment used in the ostomy center, which is provided to them, to the skin around the ostomy at a specified time after cleaning the skin around the ostomy with water. Repeat every day for 14 consecutive days. During the intervention, the wound around the stoma is evaluated by the tool for examining the skin around the stoma on the 3rd and 21st days, the duration of the treatment is evaluated by visiting the patient in person, and on the 7th and 14th, the skin around the stoma is evaluated virtually by the photos sent by the patients of the skin around the stoma. An ostomy will be made. It should be noted that during the study, patients will be continuously taught through virtual communication channels such as WhatsApp.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Ostomy Society
Full name of responsible person
Hadi Manafi
Street address
No. 6, Shahid Ismailzade Alishah Alley (Maghan), Shahid Mirzaei Bei Ghosh St. (4th), Fatemi St
City
Tehran
Province
Tehran
Postal code
1415755991
Phone
+98 21 8896 9602
Fax
+98 21 8896 9602
Email
info@iranostomy.com
Web page address
https://iranostomy.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Vahidi
Street address
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5366
Email
sbmuf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
kimia Miri
Position
MSc Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5366
Email
kimiamiri@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Zandi
Position
Post Doctorate in Nursing, Member of Faculty of Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5366
Email
mitra.zandi@yahoo.com
Web page address
https://nm.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kimia Miri
Position
MSc Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery, Shahid Beheshti University, Wali Asr St., Niayesh Intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5366
Email
kimiamiri@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir

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
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
Yes - There is 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
Title and more details about the data/document
Results and data that are not ethically prohibited will be made available
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Person responsible for scientific inquiries & Person responsible for general inquiries
Under which criteria data/document could be used
Checking for non-contradiction with the ethical principles of research and preserving the effect of ownership
From where data/document is obtainable
Person responsible for scientific inquiries & Person responsible for general inquiries
What processes are involved for a request to access data/document
Checking for non-contradiction with the ethical principles of research and preserving the effect of ownership
Comments
Loading...