This study is a clinical trial to investigate the effect of Achillea millefolium based on Traditional Medicine on vaginal candidiasis.
Design
In this research, 70 eligible patients referring to the Fatima Al-zahra Infertility Center of Babol University of Medical Sciences were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study will be conducted in two groups in parallel for one month. The number of participants in each group is 35. With the approval of a Gynecologist, patients who have the inclusion criteria will be included in this study with simple consecutive sampling and the participants give their full consent.This triple blind study will be limited to the Fatima Al-zahra Infertility Center that way tubes and creams are quite similar in two groups and investigator, volunteers, and data analyser are unaware of allocation.
Participants/Inclusion and exclusion criteria
The main inclusion criteria are sign and symptoms of vulvovaginal candidiasis; positive smear and culture from vaginal discharges; non-complicated vaginal candidiasis on diagnosis of Gynecologist. The main exclusion criteria is side effects or drug reactions.
Intervention groups
Patients are included in the two groups after confirmation of Candida infection by smear. One group gives aqueous extract of Achillea millefolium and the other group gives clotrimazole cream 1%. Both groups are in form of vaginal cream, an applicator nightly for one week.
Main outcome variables
People in the study before and 7-10 days after the beginning of interventions and 2-3 weeks after the end of interventions will be investigated by self-report ,physical examination, PH, smear and culture from vaginal discharges and probable side effects of the drug and the effect of medication on the mentioned parameters.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170918036261N1
Registration date:2017-11-28, 1396/09/07
Registration timing:prospective
Last update:2017-11-28, 1396/09/07
Update count:0
Registration date
2017-11-28, 1396/09/07
Registrant information
Name
somayeh zakerii
Name of organization / entity
babol univercity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 4428 4828
Email address
s.zakeri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
babol medical univercity
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision effect of Achillea millefolium products on traditional medicine base, with clotrimazole cream 1% on vaginal candidiasis.
Public title
The effect of yarrow vaginal cream on treatment of candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married women,18 to 45 years old
The presence of sign and symptoms of candida vulvovaginitis
Positive smear from vaginal discharge for candida
Positive culture of vaginal discharge for candida
Exclusion criteria:
History of allergy to clotrimazole vaginal cream
History of drug allergy
Pregnancy
Mensturation period
Breastfeeding
Menopause
The presence of chronic underlying diseases: kidney, liver and Heart diseases, Diabetes and Immune deficiency
Score 24-30 based on DLQI questionnaire
Vulvar erythem score 3
Use of systemic antibiotics, immunosuppressive drugs or other vaginal creams and antifungal drugs during the past 4 weeks
Patient's unsatisfactory to participate in the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software. The sequencing will be done by quadruple blocking. Concealing done by using simillar form and size tubes for both groups, and neither the interventions nor the volunteers nor the data analyzer knows how to allocate the intervention.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients are completely unaware of which drugs they received. Also, the investigator and data analyzer are completely unaware that the two groups received which drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Science
Street address
karegar squar., Ganjafrooz street., Babol University of Medical Science., Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
MUBABOL.HRI.REC.1396.83
Health conditions studied
1
Description of health condition studied
Candida vulvovaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Burning
Timepoint
At first, 7-10 days after the beginning of interventon and 2-3 weeks after the end of intervention
Method of measurement
Evauation of clinical symptom's remission (burning) with Dermatology Quality of Life Index (DLQI ) questionnaire
2
Description
Pruritus
Timepoint
At first, 7-10 days after the begining of interventon and 2-3 weeks after the end of intervention
Method of measurement
Evauation of clinical symptom's remission (pruritus) with Dermatology Quality of Life Index (DLQI ) questionnaire
3
Description
Dysparonia
Timepoint
At first, 7-10days after the begining of interventon and 2-3 weeks at the end of intervention
Method of measurement
Evauation the rate of satisfactory from intercourse with Dermatology Quality of Life Index (DLQI ) questionnaire
4
Description
Volvar erythema
Timepoint
At first, 7-10days after the begining of interventon and 2-3 weeks at the end of intervention
Method of measurement
Vulvar examination and scoring the erythema of vulva by Gynecologist
Secondary outcomes
1
Description
Result of culture
Timepoint
At first, 7-10 days after the begining of intervention and 2-3 weeks after the end of intervention
Method of measurement
Sampling from vaginal discharges
Intervention groups
1
Description
Intervention group: Vaginal cream 2% of aqueous extract of Achillea millefolium, one applicator at night for 7 nights. Made in Pharmacy Department of Traditional Medicine, College of Traditional Medicine, Babol University of Medical Science
Category
Treatment - Drugs
2
Description
Control group: Vaginal cream of clotrimazol 1% made by the PARS DAROU pharmaceutical company; Tehran, IRAN. One applicator at night for 7 nights.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Al-zahra Infertility and Reproductive Health Research Center
Full name of responsible person
Doctor Sedighe Esmaeelzade
Street address
Fatima Al-zahra Infertility and Reproductive Health Research Center.,Torkmahalle., 3 Km after Mohammad Hassan khan bridge., Babol
City
Babol
Province
Mazandaran
Postal code
4719173716
Phone
+98 11 3227 4889
Email
www.sesmael@yahoo.com
Web page address
http://www.fzmubabol.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Babol University of Medical Sciences
Full name of responsible person
Doctor Ali Akbar Moghadam Nia
Street address
University of Medical Sciences., Ganjafrooz Street, Karegar square, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
moghadamnia@yahoo.com
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 Babol 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
Babol Univesity of Medical Sciences
Full name of responsible person
Somaye Zakerii
Position
PhD Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Babol Traditional Medicine College, Babol Univesity of Medical Sciences, Ganjafrooz Street, Karwgar Squar, Babol
City
Babol
Province
Mazandaran
Postal code
46159-73899
Phone
+98 11 4308 3172
Fax
Email
www.drzakerii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Doctor Nargess Gorji
Position
Assistant Professor Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Babol Traditional Medicine college, Babol University of Medical Sciences, Ganjafrooz street, Karegar Square
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Fax
Email
www.nargess_girji@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Somaye Zakerii
Position
PhD Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Babol Traditional Medicine college, Babol University of Medical Science, Ganjafrooz Street, Karegar Square
City
Babol
Province
Mazandaran
Postal code
46159-73899
Phone
+98 11 4308 3172
Fax
Email
www.drzakerii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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