Study of the efficacy of Indigo Naturalis ointment in the treatment of Plaque – type Psoriasis and comparison between ointments made of two different Chinese and Iranian herbs and betamethasone ointment
Psoriasis is an inflammatory chronic disease, which is characterized with erythemato plaques on the body surface. Its incidence is estimated about 1-3%. Indigo Naturalis is a herbal pigment which has been commonly used for the treatment of inflammatory dermatitis and dermatoses in Chinese Medicine. This pigment could be extracted from 5 Chinese herbs among them, Indigofera tinctoria is available in Iran. The aim of this study is to evaluate the therapeutic effect of Indigo Naturalis out of Baphicacanthus cusia (made in China) on psoriasis in comparison to the ointment out of Indigofera tinctoria (made in Iran) and Betamethasone . Patients with plaque type psoriasis will be selected regarding the inclusion and exclusion criteria. Patients will be randomly divided into three groups (Betamethasone, Iranian product of Indigofera tinctoria, Chinese form of Indigo Naturalis). PASI score will measured before the treatment, at week 2, 4, 6 and 8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512157265N5
Registration date:2016-04-16, 1395/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-16, 1395/01/28
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-23, 1394/10/02
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of Indigo Naturalis ointment in the treatment of Plaque – type Psoriasis and comparison between ointments made of two different Chinese and Iranian herbs and betamethasone ointment
Public title
Study of the efficacy of Indigo Naturalis ointment in the treatment of Plaque – type Psoriasis and comparison between ointments made of two different Chinese and Iranian herbs and betamethasone ointment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 12 years old and more; chronic plaque psoriasis; lesion extension less than 10% body surface area, bilateral lesions on the extremities; do not have another important diseases, especially liver and kidney diseases.
Exclusion criteria: use of topical drugs in the last 14 days or systemic drug in the last 30 days; pregnancy or a plan to get pregnant, breast-feeding; people with hepatitis B and C and HIV positive patients; allergy to herbal medicines; abnormal laboratory findings; use of topical or systemic drugs that have a positive or negative effect on progression of the disease.
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2009-09-09, 1388/06/18
Ethics committee reference number
87691
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
PASI score
Timepoint
Before treatment, week 2, week 4, week 6, week 8
Method of measurement
Comparison between ointments made of two different Chinese and Iranian herbs and betamethasone ointment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment by Chinese ointment of Indigo Naturalis containing 20% Indigo Naturalis (produced by Tongrentang Pharmaceutical company, Beijing, China) and 80% vehicle (25% Vaseline, 30% yellow wax, and 45% olive oil); topical treatment twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Treatment by Iranian ointment containing 20% Indigofera tinctoria extract (Plant powder with 70% ethanol) and 80% vehicle (25% Vaseline, 30% yellow wax, and 45% olive oil); topical treatment twice a day for 8 weeks
Category
Treatment - Drugs
3
Description
Control group: Topical treatment by betamethasone ointment 0.1%+ Edible dyes twice a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic and Dermatology and Leishmaniasis Research Center
Full name of responsible person
Dr. Mohammad Javad Yadanpanah
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
MUM's central office, Daneshgah street, Mashhad
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
Department of Chinese and complementary medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
MD, PhD in Accupuncture, Assistant Professor
Other areas of specialty/work
Street address
Center of accupuncture and massage, Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Meical Sciences
Full name of responsible person
Dr Mohammad Javad Yazdanpanah
Position
Dermatologist, Associate Professor
Other areas of specialty/work
Street address
Department of Dermatology, Qaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3801 2861
Fax
Email
yazdanpanahmj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Dr. Mohammad Imani
Position
Dermatologist
Other areas of specialty/work
Street address
Imam Reza Hospital, Khoramshahr square
City
Bojnord
Postal code
Phone
+98 58 5622 4011
Fax
Email
dr_imani2008@yahoo.com
Web page address
http://www.skinhealth.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)