To determine the effect of white beet leaf spray (Beta vulgaris ) on the symptoms of patients with dandruff
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 210 patients, Block randomization method will be used for randomization.
Settings and conduct
Study place is Touba specialized clinic in Sari; Study population is subjects with dandruff; Type of blinding: double blind in which participant and researcher is not aware of kinds of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with mild to moderate dandruff; Age between 18 and 65 years; Exclusion criteria: pregnancy; lactation; Liver disease; History of severe allergies
Intervention groups
Intervention group: Patients use the usual dandruff medicine (ketoconazole) for 2 weeks and, in addition, they receive 20 puffs of beet leaf spray twice a day, every other day. Control group: Patients take the usual dandruff medicine (ketoconazole) for 2 weeks and, in addition, they receive 20 puffs of placebo spray twice a day, every other day.
Main outcome variables
Scaling; Itching; Inflammation and redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211225053521N1
Registration date:2022-03-15, 1400/12/24
Registration timing:prospective
Last update:2022-03-15, 1400/12/24
Update count:0
Registration date
2022-03-15, 1400/12/24
Registrant information
Name
Akram Amraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 4893
Email address
a.amraei@ mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of white beet leaf spray (Beta vulgaris) with placebo in controlling itching and scaling symptoms in dandruff patients
Public title
The effect of leaf white beet (Beta vulgaris) spray on dandruff
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate dandruff
Age between 18 and 65 years
Exclusion criteria:
Pregnancy
lactation
Liver disease
History of severe allergies
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation process will be done with Random allocation software. With this software, 35 blocks of six will be produced and based on this, the samples will be assigned to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Moallem square, Moallem avenue
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.MAZUMS.REC.1400.684
Health conditions studied
1
Description of health condition studied
Seborrhoea
ICD-10 code
L21.0
ICD-10 code description
Seborrhea capitis
Primary outcomes
1
Description
Scaling
Timepoint
Before the intervention, days 6, 10, 15, and 15 and 30 days after the intervention.
Method of measurement
Adherent scalp flaking score
2
Description
pruritus
Timepoint
Before the intervention, days 6, 10, 15, and 15 and 30 days after the intervention.
Method of measurement
Excoriation Pruritus Grading
3
Description
Inflammation and redness of the head
Timepoint
Before the intervention, days 6, 10, 15, and 15 and 30 days after the intervention.
Method of measurement
Grading method from 0 (none) to 4 (very severe)
Secondary outcomes
1
Description
Patients' satisfaction with treatment
Timepoint
Before the intervention, days 6, 10, 15, and 15 and 30 days after the intervention.
Method of measurement
It is checked by asking and giving points from zero to 100.
Intervention groups
1
Description
Intervention group: In this study, patients will be treated routinely (ketoconazole shampoo) for 2 weeks, and in addition, every other day, they use a herbal beet leaf extract spray 20 puffs twice a day.
Category
Treatment - Drugs
2
Description
Control group: In this study, patients will be treated routinely (ketoconazole shampoo) for 2 weeks, and in addition, every other day, they use a placebo spray 20 puffs twice a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Subspecialty Clinic (Touba)
Full name of responsible person
Dr Assie Jokar
Street address
Khazar Bolvd.
City
Sari
Province
Mazandaran
Postal code
4811573397148
Phone
+98 11 3324 0002
Email
a.jokar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Deputy of Research and Technology; Mazandaran University of Medical Sciences; Moalem Ave.; Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 3117
Email
a.jokar@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 3117
Email
a.jokar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akram Amraei
Position
Persian Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 3117
Email
akramamraei2020@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
Undecided - It is not yet known if there will be 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