Protocol summary

Summary
The main aim of this study is to determine the effect of herbal product "Myrtus Communis" in the treatment of genital warts in women. The study is a Double blind randomized clinical trial, two centers with placebo control. Female patient aged 18 to 50 years with vaginal or cervical wart are enrolled, patient with candida, trichomona and other infections vaginitis or cervicitis and recognized immunodeficiency or autoimmune disease, HIV-positive patients, Long-term use of corticosteroids or immunosuppressive, smoking, pregnancy, those who had CIN2 and CIN3 in cervix biopsy are excluded. The total number of 60 patients is taken into account that randomly will be divided into two groups: intervention and control.The intervention group are treated with 60 Myrtus vaginal suppositories one every night except during menstruation period. The control group are treated with 60 placebo vaginal suppositories one every night except during menstruation period. The dietary recommendations based on iranian traditional medicine will be given to all patient. The study period is three months. The main outcome measure of the study is HPV test and related consequences outcome are lesion size, clinical symptom, drug side effects. Candidates are checked for HPV virus, lesion size at the baseline and the end of the study,for clinical symptom at the baseline,end of the first and the second and the third month of the study,for drug side effects during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092429936N1
Registration date: 2016-12-23, 1395/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Zahra Nikakhtar
Name of organization / entity
Mashhad University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 6780
Email address
nikakhtarz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of herbal product " Myrtus communis " with placebo on the treatment of genital warts in women
Public title
The effects of traditional medicine product in genital wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female patient with vaginal or cervical wart; age between 18 to 50 years Exclusion criteria: patient with Candida, trichomona and other infections vaginitis or cervicitis; patients with recognized immunodeficiency or autoimmune disease; HIV positive patients; Long-term use of corticosteroids or immunosuppressive; smoking; pregnancy; those who had CIN2 and CIN3 in cervix biopsy; Lack of satisfaction in every stage of the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.MUMS.REC.1395.299

Health conditions studied

1

Description of health condition studied
Genital wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts

2

Description of health condition studied
Cervix dysplasia
ICD-10 code
N87.0
ICD-10 code description
Mild cervical dysplasia

3

Description of health condition studied
vaginal dysplasia
ICD-10 code
N89,0
ICD-10 code description
Mild vaginal dysplasia

4

Description of health condition studied
papilloma of cervix
ICD-10 code
D26,0
ICD-10 code description
Other benign neoplasms of uterus

Primary outcomes

1

Description
HPV virus
Timepoint
Baseline, the end of the study
Method of measurement
HPV-PCR test

2

Description
Lesion size
Timepoint
Baseline,the end of the study
Method of measurement
Colposcopy

Secondary outcomes

1

Description
Clinical symptom
Timepoint
Baseline,end of the first and the second and the third month of the study
Method of measurement
According to the patient's symptoms

2

Description
Drug Side Effects
Timepoint
During the study
Method of measurement
According to the patient's symptoms

Intervention groups

1

Description
Patients are treated with 60 Myrtus vaginal suppositories one every night except during menstruation period in the intervention group . Disease status will be reviewed at the beginning and the end of the study.
Category
Treatment - Drugs

2

Description
Patients are treated with 60 placebo vaginal suppositories one every night except during menstruation period in the control group. Disease status will be reviewed at the beginning and the end of the study.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem Educational, Research and Treatment Center
Full name of responsible person
Zahra Nikakhtar
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
mashhad

2

Recruitment center
Name of recruitment center
Faculty of Iranian Traditional Medicine and Complementary
Full name of responsible person
Zahra Nikakhtar
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
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 and Technology 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
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Zahra Nikakhtar
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
nikakhtarz1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
Feyzabadiz@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person
Zahra Nikakhtar
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
nikakhtarz1@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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