The aim of this randomized, double-blinded, placebo controlled study is to evaluate the effect of curcumin tonic on scalp psoriasis. Forty patients who fulfill the inclusion criteria were randomly divided into two groups. The case group received the curcumin tonic twice a day for 9 weeks, while the other group received the placebo. Patients were evaluated baseline and on weeks 3, 6 and 9. The Dermatology quality of Life (DQOL) questionnaire and PASI (psoriasis area and severity index) scores as well as medical photos before, during and after treatment were used to evaluate the outcomes. Probable adverse effects were recorded and declared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604183106N30
Registration date:2016-11-10, 1395/08/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-10, 1395/08/20
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University
Expected recruitment start date
2015-12-30, 1394/10/09
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Turmeric tonic in the management of scalp psoriasis
Public title
Turmeric tonic in the management of scalp psoriasis; a clinical double blind, placebo controlled evaluation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definitive diagnosis of mild to moderate scalp psoriasis; Patient age 18-75 with no limitation in gender; Lack of infections or malignancies on scalp skin; Two weeks Wash out period topical and one month systemic anti psoriasis treatment; Patient agreement to participate in the clinical trial
Exclusion criteria: Pregnancy; Lactation; Allergy or irritation to any component of formulation
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Pharmaceutical Sciences branch
Street address
No1, Yakhchal street, Dr Shariati avenue, Tehran, Iran
City
Tehran
Postal code
1941933111
Approval date
2015-09-15, 1394/06/24
Ethics committee reference number
IR.IAU.PS.REC.1394.19
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Redness
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
1.Psoriasis questionnaire 2.Psoriasis quality of life questionnaire 3. photography: before, during and aftertreatment 4. PASI calculator
2
Description
Thickness
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
1.Psoriasis questionnaire 2.Psoriasis quality of life questionnaire 3. photography: before, during and after treatment 4. PASI calculator
3
Description
Scaling
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
1.Psoriasis questionnaire 2.Psoriasis quality of life questionnaire 3. photography: before, during and after treatment 4. PASI calculator
4
Description
Involved area
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
1.Psoriasis questionnaire 2.Psoriasis quality of life questionnaire 3. photography: before, during and after treatment 4. PASI calculator
5
Description
PASI score
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
PASI calculator
6
Description
Photography
Timepoint
Week 0 (baseline), week 3 , 6 , 9 to complete the follow up
Method of measurement
photography: before, during and after treatment
Secondary outcomes
1
Description
Reported side effects (systemic and local)
Timepoint
Patients were given a telephone number to call during treatment. Patient could report any side effects as well as during follow up, all the way through the treatment and after completion.
Method of measurement
Patients were given a telephone number to call during treatment. Patient could report any side effects as well as during followup, all the way through the treatment and after completion.
Intervention groups
1
Description
Apply Curcumin tonic topcally twice a day for 9 weeks.
Category
Treatment - Drugs
2
Description
Apply placebo topically twice a day for 9 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center
Full name of responsible person
Dr Parvin Mansouri
Street address
Number 4 , Maryam dead end, Kamraniyeh Blvd, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Pharmaceutical branch and Self supported
Full name of responsible person
Dr Sepideh Arbabi Bidgoli
Street address
No1 , Yakhchal street, Dr Shariati avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Pharmaceutical branch and Self supported
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
Islamic Azad University Pharmaceutical Sciences branch
Full name of responsible person
Dr Mehdi Rajabi
Position
Assistant professor, clinical pharmacy expert
Other areas of specialty/work
Street address
No1, Yakhchal street, D Shariati avenue, Tehran, Iran
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Pharmaceutical Sciences branch
Full name of responsible person
Dr Mehdi Rajabi
Position
Assistant professor, clinical pharmacy expert
Other areas of specialty/work
Street address
No1, Yakhchal street, D Shariati avenue, Tehran, Iran
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Pharmaceutical Sciences branch
Full name of responsible person
Parichehr Bahraini
Position
Student
Other areas of specialty/work
Street address
No1, Yakhchal street, D Shariati avenue, Tehran, Iran
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
p.bahraini.pharma@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)