Evaluation of the effect of oral Myrtus communis capsules in the treatment of vaginal candidiasis in patients referred to health- medical centers
affiliated to Beheshti University of Medical Sciences, in 1391
The present study has been conducted with the purpose of determination of the effect of oral Myrtus communis capsules in the treatment of vaginal candidiasis in referring to health- medical centers dependent to Beheshti University of Medical Sciences,in 1391. This study is performed as a double blind randomized clinical trial, among 100 married women 15-45 years with complains of vaginal itching or irritation. patients will be randomly divided into two groups: intervention (Myrtus communis capsules and Clotrimazole vaginal cream) and control (placebo and Clotrimazole vaginal cream). The patients use (500 mg capsules of Myrtus communis twice a day and clotrimazole vaginal cream1 % one applicator of cream at bed time for one week) and the other group (500 mg capsules of starch powder twice a day with Clotrimazole vaginal cream1%) over one weeks. Then patients will be checked 4- 7 days after completion of the treatment period and the side-effects will be registered. Data collection will accomplished demographic information questionnaire and clinical performance checklist, and these data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111264529N4
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Nourossadat Kariman
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3133
Email address
n_kariman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral Myrtus communis capsules in the treatment of vaginal candidiasis in patients referred to health- medical centers
affiliated to Beheshti University of Medical Sciences, in 1391
Public title
Evaluating the effect of oral Myrtus communis capsules in the treatment of vaginal candidiasis
Purpose
Health service research
Inclusion/Exclusion criteria
nclusion criteria: 1- Being married 2- Age between 15 or 453-Positive wet smear of vaginal discharge4- Not being pregnancy, lactation and menopausal period; Not having any vaginal bleeding5- Not having chorionic disease (diabetes, HIV,…) 6-Women that hadn’t history of using antibiotic for 2 weeks befor7-Women that don’t use oral contraceptive pills 8-Not being overweight (Body Mass Index>29)9- Not having intercourse and vaginal douching during the last11 hours10- Not using any antifungal drugs, for 2 weeks before the study11-Not using vaginal cream for last 48 hours before the study12- Not having allergy with herbal drugs 13-only sexual partner 14- not having trichomonal vaginitis and bacterial vaginitis Exclusion criteria:1-druges intulerance ،Having allergy with herbal drugs 2- pregnancy in study time 3- unwillingness to continue participation in this study 4- emergency use of antibiotic in study time 5- taking any other herbal remedy during the study 6- abnormal Pap smear results at 2 years 7-Failure to follow the correct method of treatment provided, taking more than one pill a day to forget and be forgotten vaginal cream more than one night
Age
From 15 years old to 45 years old
Gender
Female
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed beheshti medical university, Dean of research
Street address
Tehran, Evin, Shaheed beheshti medical university
City
tehran
Postal code
-
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
122
Health conditions studied
1
Description of health condition studied
vaginal candidiasis
ICD-10 code
B37.3+
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginitis
Timepoint
Four to 7 days ofter completion of the treatment period
Method of measurement
Accomplished demographic information questionnaire and clinical performance checklist, clinical observation-pH value vaginal discharge and direct microscopy examination
Secondary outcomes
empty
Intervention groups
1
Description
The patients in placebo group use 500 mg capsules of starch powder twice a day with clotrimazole vaginal cream1%.One applicator of cream use at bed time for one week
Category
Treatment - Drugs
2
Description
The patients in intervdntion group use 500 mg capsules of Myrtus communis twice a day with clotrimazole vaginal cream1 % One applicator of cream will be used at bed time for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital lolagar
Full name of responsible person
Fatemeh Rozbahani
Street address
khosh streets - more than veterinary
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shaheed beheshti medical university
Full name of responsible person
Dr.Massome Simbar
Street address
Shahid Chamran highway- Yaman street- next to Taleghani hospital-Shahid Beheshti University of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shaheed beheshti medical university
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Rozbahani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Niayesh Street ,Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Postal code
-
Phone
+98 21 4469 1711
Fax
-
Email
rahgozar_gharib00@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
shaheed beheshti medical university
Full name of responsible person
nourossadat kariman
Position
master of science in midwifery
Other areas of specialty/work
Street address
shaheed beheshti medical university
City
tehran
Postal code
-
Phone
+98 21 8820 2512
Fax
-
Email
n_kariman@sbmu.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Rozbahani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Niayesh Street ,Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 4469 1711
Fax
Email
rahgozar_gharib@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)