Protocol summary

Study aim
The evaluation of the effect of Melissa officinalis syrup (A traditional medicine formula) on the mild to moderate psoriasis
Design
Two arm parallel group randomised trial
Settings and conduct
Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Mild to moderate psoriatic patients, with 18 years old age or more.
Intervention groups
12 weeks of intervention with placebo & medication
Main outcome variables
QoL, disease severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045326N1
Registration date: 2019-11-09, 1398/08/18
Registration timing: prospective

Last update: 2019-11-09, 1398/08/18
Update count: 0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
alireza yargholi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2292 2510
Email address
a-yargholi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of Melissa officinalis syrup (A traditional medicine formula) on the mild to moderate Psoriasis.
Public title
The evaluation of the effect of Melissa officinalis syrup (A traditional medicine formula) on the mild to moderate Psoriasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aga>=18 years old
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research the physician,participants(patients) and the statistician are blinded
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 10, Khark Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2019-10-23, 1398/08/01
Ethics committee reference number
IR.TUMS.VCR.REC.1397.424

Health conditions studied

1

Description of health condition studied
Psoriasis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
disease severity with Psoriasis Area Severity Index (PASI)
Timepoint
before intervention, 8th and 12th week of intervention
Method of measurement
PASI score sheet

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Traditional Medicine, TUMS
Full name of responsible person
Alireza Yargholi
Street address
No. 10, Khark Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
000000000
Phone
+98 21 6675 4154
Email
alirezayargholi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy Dean for Research
Street address
No. 10, Khark Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2298 8551
Email
alirezayargholi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Yargholi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 91, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2292 2510
Email
alirezayargholi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hossein Ayati
Position
Assistant Professor of Traditional Medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
No. 10, Khark Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 6675 4154
Email
mh-ayati@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Yargholi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 91, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2292 2510
Email
alirezayargholi@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
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
No more information is available
When the data will become available and for how long
No more information is available
To whom data/document is available
No more information is available
Under which criteria data/document could be used
No more information is available
From where data/document is obtainable
No more information is available
What processes are involved for a request to access data/document
No more information is available
Comments
Loading...