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Evaluation of the efficacy and safety of Purslane (Portulaca oleracea) Product on Clinical Symptoms of Mild to Moderate Chronic Hand Dermatitis

Protocol summary

Study aim
Determination of efficacy and safety of Portulaca oleracea product on clinical signs of mild to moderate chronic dermatitis
Design
Clinical trial with control group, parallel, double blinded, randomized, sample size: 70 patients
Settings and conduct
In this double-blind study, patients with mild to moderate chronic dermatitis referred to traditional medicine clinics are approved by a dermatologist and randomly divided into intervention and control groups. Before studying, the consent form and related questionnaires are completed and the dermatitis site is photographed. The drug is delivered to the patient. At the end of the second, fourth and eighth weeks, after the intervention, the patient is followed up and the relevant forms are completed, and the dermatitis is photographed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic unilateral or bilateral hand dermatitis, including occupational, allergic or irritative dermatitis, age range 18 to 70 years, referred to traditional health center, willingness and satisfaction to participate in the study. exclusion criteria: patients under 18 years, patients over 70 years, lactation, pregnancy, severe dermatitis, patients with underlying diseases such as cardiovascular failure, diabetes, immunodeficiency, autoimmune diseases, spinal cord diseases, patients taking drugs for diseases Other, other acute illness during treatment, infection at the site of dermatitis, patients sensitive to Portulaca.
Intervention groups
The control group received placebo syrup and Vaseline cream and the intervention group received Portulaca oleracea syrup and Vaseline cream.
Main outcome variables
Erythema, edema, fissure, scaling, itching, dryness, skin thickness, drug side effects, quality of life index in skin diseases, recurrence of symptoms after treatment, overall satisfaction of patients with treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200707048040N1
Registration date: 2020-08-08, 1399/05/18
Registration timing: prospective

Last update: 2020-08-08, 1399/05/18
Update count: 0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Sedigheh Rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
rastegar.sedigheh54@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Purslane (Portulaca oleracea) Product on Clinical Symptoms of Mild to Moderate Chronic Hand Dermatitis
Public title
The effect of Portulaca oleracea syrup on mild to moderate chronic hand dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic unilateral or bilateral hand dermatitis, including occupational dermatitis, allergic dermatitis or irritative dermatitis Age range 18 to 70 years Willingness and satisfaction to participate in the study Referred to traditional medicine center
Exclusion criteria:
Breastfeeding Pregnancy Patients with severe dermatitis Patients with underlying diseases such as cardiovascular failure, diabetes, immune deficiency, autoimmune diseases, spinal cord diseases Patients taking medication for their other illnesses Patients who develop another acute illness during treatment Patients who have an infection at the site of their dermatitis Patients who are allergic to Portulaca oleracea
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Randomization unit block: Individual Randomization tool: Random number table How to make a sequence: In a random number table, a number is randomly selected from the table and arranged in rows or columns in the up and down and left or right numbers. Next are selected. Because the number of modes of 4 blocks for two groups is 6 modes, numbers higher than 6 and zero are ignored in the table and each digit specifies the desired block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Portulaca oleracea and placebo have been coded for blinding. The patient, researcher, and analyzer are also unaware of the type of drug administered.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman Ave., Sh. Aarabi Ave., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.278

Health conditions studied

1

Description of health condition studied
mild to moderate chronic dermatitis
ICD-10 code
L30.9
ICD-10 code description
Dermatitis, unspecified

Primary outcomes

1

Description
Erythema
Timepoint
Week zero, the end of the fourth and eighth weeks
Method of measurement
HECSI Scale

2

Description
edema
Timepoint
Week zero, the end of the fourth and eighth weeks
Method of measurement
HECSI Scale

3

Description
fissure
Timepoint
Week zero, the end of the fourth and eighth weeks
Method of measurement
HECSI Scale

4

Description
scaling
Timepoint
Week zero, the end of the fourth and eighth weeks
Method of measurement
HECSI Scale

5

Description
itching
Timepoint
Week zero, the end of the second, fourth and eighth weeks
Method of measurement
VAS Scale

6

Description
dryness
Timepoint
Week zero, the end of the second, fourth and eighth weeks
Method of measurement
VAS Scale

7

Description
skin thickness
Timepoint
Week zero, the end of the second, fourth and eighth weeks
Method of measurement
VAS Scale

8

Description
drug side effects
Timepoint
Week zero, the end of the second, fourth and eighth weeks
Method of measurement
Question from the patient

Secondary outcomes

1

Description
Dermatology life quality index
Timepoint
Week zero, the end of the fourth and eighth weeks
Method of measurement
DLQI questionnair

2

Description
Patients' overall satisfaction with treatment
Timepoint
End of the fourth week
Method of measurement
Likert Scale

3

Description
Recurrence of symptoms after treatment
Timepoint
the end of the eighth week
Method of measurement
Question from the patient

Intervention groups

1

Description
Intervention group: Intervention group: Recipient of Portulaca oleracea syrup (25 mg/ ml) 10 cc three times a day for 4 weeks orally prepared to contain aqueous extract of Portulaca oleracea and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine, Samin Vaseline cream produced by Golafshan company should be rubbed on the dermatitis area every night as a surface layer for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: Control group: 10 cc placebo syrup recipient three times a day for 4 weeks orally and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine. Rub a surface layer for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariat Panahi Traditional Medicine Health Center
Full name of responsible person
Sedigheh Rastegar
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6029
Fax
Email
rastegar.sedigheh54@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
5th Floor, Bldg No.2 SBUMS, Sh. Aarabi Ave, Yaman Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@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
Sedigheh Rastegar
Position
MD, MPH, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
rastegar.sedigheh54@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Rastegar
Position
MD, MPH, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
rastegar.sedigheh54@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Rastegar
Position
MD, MPH, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
rastegar.sedigheh54@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publication of the results in the form of a doctoral dissertation and an ISI article
When the data will become available and for how long
After PhD thesis defence
To whom data/document is available
public
Under which criteria data/document could be used
for research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Approval of the relevant responsible
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