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Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial.

Protocol summary

Study aim
Evaluation of the role of oral whey protein with Terminalia Chebula (an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial
Design
A Triple-blind randomized controlled trial, with parallel groups and blinded outcome assessment, on 90 patients. Using Random Allocation Software or RAS, patients are divided into 2 groups: the intervention (whey protein with terminalia chebula) group and the control group (whey protein with starch).
Settings and conduct
90-patients diagnosed with psoriasis would be studied in the Center for Research and Training in Skin Disease and Leprosy. After applying the inclusion and exclusion criteria of the study and completing the informed consent form they are placed in one of the intervention or control groups using random blockade.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient diagnosed with mild to moderate controlled plaque psoriasis with less than 10% of skin involvement,that have age between 18 and 60. Exclusion criteria: History of the sever heart, and pulmonary and kidney disease, pregnancy and breastfeeding.
Intervention groups
Intervention group: The standard treatment + whey protein with terminalia chebula. Control group: Standard treatment + whey protein with placebo (starch).
Main outcome variables
Assessing the severity of the disease both before the treatment begins and at the end of the sixth and twelfth weeks, using PASI score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230618058508N1
Registration date: 2023-07-02, 1402/04/11
Registration timing: prospective

Last update: 2023-07-02, 1402/04/11
Update count: 0
Registration date
2023-07-02, 1402/04/11
Registrant information
Name
nasrin azhang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4410 8623
Email address
nasrinazhang@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial.
Public title
Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 Less than 10% of skin involvement Suffering from controlled plaque psoriasis (Unchanged damages in terms of severity and extent in the last 2 months) Not using psoralen in the last 28 days and not receiving UVB in the last 30 days No kidney disease or kidney stones Not being during pregnancy and breastfeeding Not participating in any study in the last month Consent to participate in the study
Exclusion criteria:
Suffering from other types of psoriasis, such as pustular, erythrodermic, palmoplantar, psoriatic arthritis Allergy to milk and other dairy product Suffering from kidney stones and kidney disease Using drugs aggravating psoriasis, such as beta-blockers, non-steroidal anti-inflammatory drugs, calcium channel blockers, interleukins, and lithium suffering from uncontrolled cardiovascular, respiratory, hematologic or urinary diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using random allocation software and creating a table of permutation blocks, which will have 15 blocks of six according to the size of sample and groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this project, the pharmaceutical consultant prepares medicine (whey protein and yellow Halila) and placebo (whey protein and starch) in the form of powder in cans of the same shape, weight, and color with specific codes. First, the demographic information is recorded on the form, and then the pocket containing medicine and placebo would be opened and randomly given to people in two groups. It should be noted that all these processes will be carried out by a pharmaceutical consultant and research assistant. In this study, the doctor, the patient and the statistician do not know the contents of the cans.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institute of Pharmaceutical Sciences - Tehran University of Medical Sciences
Street address
13th floor,A bloc, Simay iran St., between Falamak St. and Zarafshan St.,
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-06-11, 1402/03/21
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.034

Health conditions studied

1

Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris

Primary outcomes

1

Description
Assessment of disease severity
Timepoint
Before starting the treatment and at the end of weeks 6 and 12
Method of measurement
Using PASI score

2

Description
Evaluation of the extent of the lesion
Timepoint
Before starting the treatment and at the end of weeks 6 and 12
Method of measurement
Using the BSA index

3

Description
Assessment of quality of life
Timepoint
It is evaluated before the start of the treatment and at the end of the 12th week.
Method of measurement
Using the DLQI index, which is taken from the patient in the form of a questionnaire

4

Description
Assessment of itching severity
Timepoint
It is evaluated before the start of the treatment and at the end of weeks 6 and 12
Method of measurement
Using the VAS index

5

Description
Investigation of possible gastrointestinal and skin complications
Timepoint
At the end of weeks 6 and 12
Method of measurement
Using the fifth version of Common Terminology for Adverse Event questionnaire (CTCAE)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with terminalia chebula once a day. This group dissolves a full tablespoon (10 grams) of the drug in 1 glass of warm water and drinks it in the morning, about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps.
Category
Treatment - Drugs

2

Description
Control group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with starch once a day. This group dissolves a full tablespoon (10 grams) of the placebo in 1 glass of warm water and drinks it in the morning about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
center for research and training in skin disease and and leprosy
Full name of responsible person
Nasrin Azhang
Street address
No. 415, corner of Naderi St., Shahid Taleghani St.
City
Tehran
Province
Tehran
Postal code
638314155
Phone
+98 21 8897 2221
Fax
+98 21 8896 3804
Email
crtsdl@tums.ac.ir
Web page address
https://crtsdl.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hossein Ayati
Street address
Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6640 5666
Email
tumspr@tums.ac.ir
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
Nasrin Azhang
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, north sarparast st., western taleghani st., felestin squ.
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8897 4535
Email
nasrinazhang@yahoo.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
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, north sarparast st., western taleghani st., felestin squ.
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱۱۱
Phone
+98 21 8897 4535
Email
Ayatimd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Azhang
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, north sarparast st., western taleghani st., felestin squ.
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8897 4535
Email
nasrinazhang@yahoo.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
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
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
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
All academic people
Under which criteria data/document could be used
After the publication of the article and for other studies and therapeutic use.
From where data/document is obtainable
The person responsible for general accountability
What processes are involved for a request to access data/document
Communication with the person responsible for general accountability
Comments
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