The effect of olive leaf extract and curcumin combination on improvement of clinical signs and symptoms and quality of life in patients with external anogenital wart
Determining the effect of combination of olive leaf extract and curcumin on improving clinical signs and symptoms and quality of life of patients with external anogenital warts
Design
Clinical trial with control group, three-way blind, randomized with randomized block.
Settings and conduct
The study is performed in the medical centers of the province with two groups of intervention and control by blinding the patient, the researcher and the analyzer using the coding of individuals, drugs and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Confirmation and introduction of midwifery specialist
Age 18 and up
Lack of pregnancy and lactation
The desire to participate in research and sign the informed consent
Lack of incurable, metabolic and chronic diseases and weakness in the immune system
Lack of pelvic inflammatory disease, other genital infectious diseases
Do not use corticosteroids and antiviral drugs and weaken the immune system during research
Failure to participate in other research that in any way affects the results of the research
Phone access
Exit criteria:
Lack of proper and appropriate use of drugs
Lack of desire to continue research
Any allergies caused by the drug
Failure to answer the phone
Pregnancy
Severe type of disease that requires surgery or systemic medication.
Intervention groups
Control group: Routine treatment with 20% pedophyllin once a week and the use of placebo (2 mm) 3 times a day until recovery for up to 12 weeks.
Intervention group: Use of 20% pedophylline once a week and 10% olive leaf extract ointment and 10% curcumin (2 mm) 3 times a day until recovery for up to 12 weeks.
Main outcome variables
Clinical signs and symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047350N1
Registration date:2020-05-14, 1399/02/25
Registration timing:prospective
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Fateme Mehrabirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 7364
Email address
fatememehrabirad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olive leaf extract and curcumin combination on improvement of clinical signs and symptoms and quality of life in patients with external anogenital wart
Public title
The effect of olive leaf extract and curcumin combination on improvement of clinical signs and symptoms and quality of life in patients with external anogenital wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation and introduction of a midwifery specialist for the patient to enter the study (having external anogenital warts)
Age 18 and up
No pregnancy or lactation
The desire to participate in research and sign a conscious consent
Lack of incurable, metabolic and chronic diseases and weakness in the immune system
Do not use corticosteroids or antiviral drugs and weaken the immune system during research
Lack of pelvic inflammatory disease, other genital infectious diseases
Failure to participate in other research that in any way affects the results of the research
Phone access
Exclusion criteria:
Lack of proper and appropriate use of drugs
Lack of desire to continue research
Any allergies caused by the drug
Disabling the patient or changing the patient's contact number and not answering the phone call
Pregnancy
Severe type of disease that requires surgery or systemic medication
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Random block block The volume of each block is 4, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the Research Center codes the drug and placebo with specific and confidential codes. While using the patient, the researcher, the analyst, is not aware of the research groups (whether the patient has received the medication or the placebo) and is only in the groups with the medication codes they received. Finally, after analyzing the data, decryption is performed by the research center.
Placebo
Used
Assignment
Parallel
Other design features
Routine treatment in both groups means that on the first day of treatment, the midwife will first cover the wart with Vaseline cream containing vitamin E and then place a full swab soaked in pedophyllin 20% on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of the drug is placed on the inside of the forearm for 20 minutes and the redness, itching, burning, swelling and skin lesions will be examined. The lesion will be washed with water. Then the site of the lesion is dried and patients, according to the control groups and olive-curcumin leaf extract, apply 10% ointment to the lesions with a swab, and do not wash it until the next dose. This is done from the first day of treatment after pedophilia (once a week) for 3 times a day until complete recovery (maximum 12 weeks). The exact time and date of the start of treatment will be recorded by the researcher and the patient will be given the necessary training to take the medication. To receive pedophylline, the patient sees a specialist once a week, and the disease is examined and, if necessary, continued treatment. How to blind the study is done in such a way that the patient and the researcher and statistical analyst do not know how to divide people into groups. Each person will receive their own code and will be grouped into 1.2 groups using coding. Then, with the help of an obstetrician's examination, the treatment process is checked by observing privacy and the principle of confidentiality. The patient informs the researcher of the time of recovery of the lesions after the start of treatment as the exact time and date. The number of lesions before consumption, daily (at intervals of weekly visits by the patient), is examined and recorded every week by a midwife by direct observation according to the time of complete recovery after taking the medication. The quality of life questionnaire will be completed by the researcher before starting treatment and after complete recovery. The researcher will follow the patient from the first day of treatment until the next visit (once a week) using a mobile phone and contacting the patient (self-report), in terms of side effects (pain, bleeding, scaling, itching). It should be noted that the follow-up of drug use and washing by the subjects will be done by telephone by the researcher. Patients who may have a full recovery earlier than the due date should report the exact date and time of the recovery to the researcher during these calls.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.LUMS.REC.1399.045
Health conditions studied
1
Description of health condition studied
Genital Warts
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
Clinical Signs and Symptoms: In this study, the clinical signs and symptoms of itching, burning, pain, warts and bleeding are considered.
Timepoint
Every week and the intervals between visits for a maximum of 12 weeks.
Method of measurement
clinical examination, self-report
Secondary outcomes
1
Description
Quality of Life
Timepoint
The day before treatment, after clinical repair
Method of measurement
Life Quality Questionnaire 36 questions SF36
Intervention groups
1
Description
Intervention group:Routine treatment with pedophile 20% once a week until clinical repair (maximum 12 weeks) and the use of 10% olive leaf extract ointment and 10% curcumin in the amount of 2 mm) (9 made by the University Health and Nutrition Research Center) Khorramabad Medical Sciences) 3 times a day until recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophile -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of the drug is placed on the inside of the forearm for 20 minutes and the redness, itching, burning, swelling and skin lesions will be examined. The lesion will be washed with water. Then the site of the lesion is dried and the patients extract 10% of the ointment from the olive-curcumin leaf extract with a swab, and do not wash it until the next dose.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment with pedophyllin 20% once a week until clinical repair (maximum 12 weeks) and the use of placebo (size 2 mm) (manufactured by Khorramabad University of Medical Sciences) 3 times a day until Recovery (maximum 12 weeks). On the first day of treatment, the midwife will first cover the wart with a vitamin E-containing Vaseline cream and then place a full 20% pedophyllin -soaked swab on the wart. The solution should be on the lesion for 4 hours and not washed under any circumstances. Before applying the ointment, a thin layer of placebo is placed on the inside of the forearm for 20 minutes to examine for redness, itching, burning, swelling, and skin lesions. The lesion will be washed with water. Then the site of the lesion is dried and the patients are given a placebo with a swab to the lesion, to avoid washing it until the next dose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Midwifery Office
Full name of responsible person
Fateme Yari
Street address
No. 52, Royan Fertility and Infertility Health Center,Takhti Alley, Enqelab St
City
Khorramabad
Province
Lorestan
Postal code
-
Phone
+98 66 3320 7072
Email
yari1672@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tahereh Toulabi
Street address
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tahereh Toulabi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem Street
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
toulabi_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tahereh Toulabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences , Shahid Anoushirvan Rezaei Square , Moallem Street
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
toulabi_t@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fateme Mehrabi Rad
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alley Banafshe 4, Arghavan St, East Goldasht
City
Khorramabad
Province
Lorestan
Postal code
6819756189
Phone
+98 66 3341 7364
Email
fatememehrabirad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the effect of the drug on primary and secondary outcomes.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
Researchers first obtain permission from the researcher and refer to their research objectives to use any data or information.
From where data/document is obtainable
Postal address: Khorramabad, Lorestan University of Medical Sciences, Faculty of Nursing and Midwifery - Fatemeh Mehrabi Rad
Contact Number: 00986633120140
Email: fatememehrabirad@gmail.com
What processes are involved for a request to access data/document
Dear researchers, you can ask your questions via email address
Email: fatememehrabirad@gmail.com. We will answer your questions as soon as possible.