The purpose of this study is to evaluate the effect of Traditional Medicine Combined Product on Kalaf in a randomized triple-blinded clinical trial design. 31 patients covered by Ghaem Hospital clinic according to inclusion criteria such as female volunteers with melasma ; female gender over the age of 18 years old and exclusion criteria such as pregnancy & milchy period, will randomly use Hydroquinon 4% as 0.5 FTU in one side of the face and prepared combined product (melon seed & Cicer arietinum) as 0.5 FTU in the other side during 12 weeks., MASI score will be registrated before the treatment , every 4 weeks & after 4 weeks of the treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112025145N1
Registration date:2016-05-03, 1395/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
marjan mahjour moghadam
Name of organization / entity
mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 915 760 2261
Email address
mahjourmm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-15, 1395/01/27
Expected recruitment end date
2016-10-15, 1395/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Traditional Medicine Combined Product Effects on Melasma (Kalaf) Patients
Public title
Effects of Iranian Traditional Medicine Combined product on Melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female volunteerswith a diagnosis of melasma older than18 years.
Exclusion criteria: Gestation or lactation period; infectious skin disease;ovarian or thyroid malfunctions; use of contraceptives or antiepileptics; recently use of corticosteroids; patients have used bleaching agents in the last four months; laser & IPL therapy in six months ago; adverse effects of drugs; mental disorders or disability
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Medical Ethics Committee
Street address
Qoreishi Building, Daneshgah St
City
Mashhad
Postal code
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.MUMS.REC.1394.730
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation Lentigo
Primary outcomes
1
Description
MASI (Melasma Area and Severity Index) score
Timepoint
Before the intervention, every four weeks during the intervention& after 4 weeks of the intervention
Method of measurement
MASI scale
Secondary outcomes
1
Description
Side effects
Timepoint
During the study
Method of measurement
Question
Intervention groups
1
Description
Use of Iranian Traditional Medicine topical product (Made of chickpeas and melon seeds) as 0.5 FTU at a fixed and desired side of the face before night sleep during 12 weeks.
Category
Treatment - Drugs
2
Description
Use of topical Hydroquinone 4% as 0.5 FTU at a fixed and desired side of the face before night sleep during 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Educational, Research and Treatment Center
Full name of responsible person
Dr. MarjanMahjourMoghadam
Street address
Ghaem clinic, Dr. Shariati Square, beginning of Ahmadabad Avenue
City
Masshad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tavakkoli-Kakhki Mandana
Street address
Faculty of Traditional Medicine, Bisim intersection, 6th Jahad, opposite of Mehran gymnasium
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Marjan Mahjour Moghadam
Position
PhD Student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No 3, 70th Fallahi, Shahid Fallahi Blvd, Ghasem Abad
City
Mashhad
Postal code
Phone
+98 51 3605 4906
Fax
Email
Mahjourmm2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Marjan Mahjour Moghadam
Position
PhD Student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Bisim intersection, 6th Jahad, opposite of Mehran gymnasium
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
Mahjourmm2 @mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Marjan Mahjour Moghadam
Position
PhD Student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Bisim intersection, 6th Jahad, opposite of Mehran gymnasium
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
Mahjourmm2 @mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)