Evaluation the effect of Jujube fruit (Ziziphus jujuba L) on skin hyperpigmentation comparison to placebo control; a double blind randomized clinical trial
Evaluation the effect of jujube fruit (Ziziphus jujuba L) on skin hyperpigmentation comparison to placebo control; a double blind randomized clinical trial
Design
Clinical trail with double blind, randomized and phase 2 will be preformed on 46 patients. Clinical trail will be design with parallel groups (placebo and medication). Random Chain Generation performed using by R-CRAN version 3.2.3. Using random permutation blocks will be made blocks (the size of each block is 4) for a total of 46volunteers (1: 1 ratio). The codes will be labeled on the drugs.
Settings and conduct
The study on hyperpigmentation was performed at the Center for Education and Research in Dermatology and Leprosy. Volunteers are divided into two groups: drug and placebo. Volunteers consume 1 tablespoon syrup twice a day for 8 weeks. Pictures from the face are taken by visioface device once before entrance and after 8 weeks. The drug is given to the volunteers by one of the staff and the same explanation is given to each of them.
Participants/Inclusion and exclusion criteria
Age;
Skin type;
Use of hormonal drugs;
Use of topical lightening products;
Allergy to components of product;
History of any deep peeling of the facial skin;
Difficulty in swallowing;
Smoking;
Pregnancy;
Breast feeding;
Systemic disease;
Intervention groups
Participants were divided into two groups: medication (extracted from jujube fruit) and placebo.
Main outcome variables
Reduce the number of spots on the skin, reduce the size and its percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N10
Registration date:2021-01-14, 1399/10/25
Registration timing:registered_while_recruiting
Last update:2021-01-14, 1399/10/25
Update count:0
Registration date
2021-01-14, 1399/10/25
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-28, 1399/07/07
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Jujube fruit (Ziziphus jujuba L) on skin hyperpigmentation comparison to placebo control; a double blind randomized clinical trial
Public title
Evaluation the effect of jujube fruit on skin hyperpigmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Skin Type (III -IV)
Aged between 18 to 60 years
Signed informed consent voluntarily and knowingly
Exclusion criteria:
Use any light sensitive drug within 3 months prior to the study
Active skin disease at test area: rosacea, atrophy, acne, eczema
Use of topical lightening products like AHA ,BHA and retinoid components within 21 days prior to the study
Documented allergies to components of test product
Use of contraceptive or any hormonal drugs
History of laser treatment or dermabrasion or deep facial peels within the past 3 months
difficulty swallowing (a condition that could impact digestion and/or absorption)
Active smoker ( last 1 years)
Current pregnancy/ breast feeding
Systemic disease (diabetics, hepatic disease, uncontrolled hypothyroidism)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Random Chain Generation performed using by R-CRAN version 3.2.3. Using random permutation blocks will be made blocks (the size of each block is 4) for a total of 46volunteers (1: 1 ratio). The codes will be labeled on the drugs. After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be given for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main researcher is responsible for taking photo from visioface device. In order to keep blinding study, volunteers receive drug by one of staff according to random numbers table. Stuff give the same explanations to each of the volunteers.
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
First Floor., School of Medicine., Building No., 1 North Door of Tehran University., Poursina St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-09-21, 1399/06/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.509
Health conditions studied
1
Description of health condition studied
hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
The numbers of skin spots, its size and percentage