Comparison the efficacy of Myrtus Communis L. and Descurainia Sophia L. as a method of traditional medicine versus salicylic acid in the treatment of wart
The main purpose of this study is comparison of Myrtus Communis L. and Descurainia Sophia L. versus salicylic acid in the treatment of wart. This study is a quantitative randomized clinical trial with control groups. Patients are divided into 4 groups by table of randomized digits. Group1: salicylic acid 16.5 %, Group 2: salicylic acid 16.5 % & Descurainia Sophia L., Group 3: Myrtus Communis L. & Group 4: Myrtus Communis L. & Descurainia Sophia L. Inclusion criteria: 1) Patients between 6 and 45 years old 2) Patients who live in Yazd 3) Total number of warts <=20 and diameter <= 1 cm. Exclusion criteria: 1) Patients who are less than 6 years old and more than 45 years old 2) Pregnancy 3) Diabetus Mellitus (DM), nephropathy, cardiovascular diseases 4) Patients who use insulin or sulfonylureas drugs 5) Total number of warts >20 6) Warts on face 7) Anogenital warts 8) Wound or active dermatologic diseases on warts 9) Receiving any treatment during prior month 10) Patients disaffiliation. Target sample size is 100 who divided into 4 groups. 1) Salicylic acid 16.5% 2) Salicylic acid 16.5% and Descurainia Sophia L. 3) Salve of Myrtus Communis L. 4) Salve of Myrtus Communis L. and Descurainia Sophia L. The duration of the study is estimated to be about 12 months. Predicted primary outcomes: 1. Decrease the number of warts by observation 2. Decrease the size of warts in millimeter by ruler 3. Decrease the period of time that warts recovered after beginning of treatment 4. Decrease the relapse rate by observation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092710947N1
Registration date:2012-12-17, 1391/09/27
Registration timing:na
Last update:
Update count:0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Elham Ghadami Yazdi
Name of organization / entity
School of Traditional Medicine, Tehran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1724 3788
Email address
e-ghadamiyazdi@razi.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice-Chancellor for Research (Tehran University of Medical Sciences)
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Myrtus Communis L. and Descurainia Sophia L. as a method of traditional medicine versus salicylic acid in the treatment of wart
Public title
Comparison of Myrtus Communis L. and Descurainia Sophia L. versus salicylic acid in the treatment of wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Patients between 6 to 45 years old 2) Patients who live in Yazd 3) Total number of wart <=20 and their largest diameter <= 1 cm. Exclusion criteria: 1) Patients less than 6 years old and more than 45 years old 2) Pregnancy 3) DM, nephropathy, cardiovascular diseases 4) Patients who use insulin or Sulfonylureas drugs 5) Total number of wart >20 6) Warts on face 7) anogenital warts 8) Wound or active dermatologic diseases on warts 9) Receiving any treatment during prior month 10) Patients disaffiliation.
Age
From 6 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research Institute for Islamic and Complementary Medicine (Tehran University of
Days 0, 20, 40 and 3 months after beginning of treatment
Method of measurement
Observation
2
Description
The size of warts
Timepoint
Days 0, 20, 40 and 3 months after beginning of treatment
Method of measurement
In millimeter by ruler
3
Description
The period of time that warts recovered after beginning of treatment
Timepoint
Days 0, 20, 40 and 3 months after beginning of treatment
Method of measurement
Day
4
Description
The relapse rate
Timepoint
Days 0, 20, 40 and 3 months after beginning of treatment
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
1) 1 drop of 16.5 % salicylic acid on each wart, once daily for 40 days. The base of salicylic acid is flexible collodion 4%. Primary substances are obtained from Sepidaj Pharmaceutical co. Tehran.
Category
Treatment - Drugs
2
Description
2) 1 drop of 16.5 % salicylic acid on each wart, once daily for 40 days and Descurainia Sophia L. twice a day 4.5 grams (gr) with adequate boiling water till 3 months.
Category
Treatment - Drugs
3
Description
Salving leaves of Myrtus Communis L. that is processed by 1 x leaves of Myrtus Communis L. and 2 x water on each wart ,twice a day for 40 days
Category
Treatment - Drugs
4
Description
Salving leaves of Myrtus Communis L. that is processed by 1 x leaves of Myrtus Communis L. and 2 x water on each wart ,twice a day forl 40 days and Descurainia Sophia L. twice a day 4.5 gr with adequate boiling water till 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farokhi Hospital
Full name of responsible person
Dr. Mohamad Ebrahim Zade Ardakani, Dermatologist, Professor assistant
Street address
Farrokhi Hospital, Farrokhi Ave., Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research (Tehran University of Medical Sciences)
Full name of responsible person
Akbar Fotuhi
Street address
Qods Street, Keshavarz Ave.,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
Vice-Chancellor for Research (Tehran 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
School of Traditional Medicine, Tehran University of Medical Sciences