The aim of this triple-blind trial is to compare the effect of calendula officinalis with clotrimazole on treatment of candida vaginitis. 124 women aged 18-45 years with known candidiasis and no other vaginal infections will be allocated into two intervention groups using block randomization with allocation ratio 1:1 and block sizes of 4 and 6, determined with a computerized program. The creams will be prepared in industrial pharmacy laboratory of Tabriz University of Medical Sciences. A person not involved in the recruitment and data collection will put the identical calendula officinalis and clotrimazole creams into sequentially numbered sealed opaque packs to conceal allocation sequence and maintain blinding. The participants will use the calendula officinalis or clotrimazole cream vaginally, one applicator every night for 7 nights. They will be recommended to comply with health issues and do not use douching, other vaginal drugs and also herbal and systemic drugs during study period. We will ask participants to come back 15-10 days and 35-30 days after initiation of treatment for evaluation of treatment and relapse, respectively. The infection diagnosis, and evaluation of treatment and relapse will be based on clinical symptoms, assessment of vaginal pH, direct observation and culture. The self-administered female sexual function index (FSFI) will be also completed at baseline and 35-30 days after intervention to assess the intervention effects on sexual function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309253706N20
Registration date:2014-03-03, 1392/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-03, 1392/12/12
Expected recruitment end date
2014-07-03, 1393/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing calendula officinalis and clotrimazole for treatment of candida vaginitis: a randomized controlled trial
Public title
Effect of calendula officinalis on treatment of candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 45 years old; being married; diagnosis of candidiasis; single sexual partner; no history of allergy to drugs and plants; being literate; giving consent to participate in the study.
Exclusion criteria: having any known chronic disease; use of any antibiotics and corticosteroids in the past two weeks; receiving antifungal drugs in the past 4 weeks; currently taking oral contraceptives; existence of other vaginal infections; any sores or lumps at the cervix; experience of severe stress over the past month; known Pregnancy; lactation; currently use of other herbal medicines; participation at another trial.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants and people involved in data collection, laboratory investigation and data analysis will be blinded of the subjects' group assignment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Research Deputy
Street address
3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
Postal code
Approval date
2014-02-10, 1392/11/21
Ethics committee reference number
92184
Health conditions studied
1
Description of health condition studied
Candida vaginitis
ICD-10 code
B37.3+
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Response to the treatment
Timepoint
10-15 days after the initiation of intervention
Method of measurement
Assessment of vaginal pH, direct observation, secretion culture
2
Description
Relapse of the infection
Timepoint
30-35 days after the initiation of intervention
Method of measurement
Assessment of vaginal pH, direct observation, secretion culture
Secondary outcomes
1
Description
Sexual function score
Timepoint
Before intervention, 30-35 days after the initation of therapy
Method of measurement
Female sexual function Index (FSFI)
2
Description
Adverse events
Timepoint
10-15 days after the initation of therapy
Method of measurement
Self-report
3
Description
Clinical complaints
Timepoint
Baseline, 10-15 and 30-35 days after initiation of intervention
Method of measurement
Self-report
4
Description
Client satisfaction
Timepoint
10-15 and 30-35 days after the initation of intervention
Method of measurement
Self-report
Intervention groups
1
Description
Intervention I: vaginal use of Calendula Officinalis cream, one aplicator every night for 7 nights
Category
Treatment - Drugs
2
Description
Intervention II: Vaginal use of Clotrimazole cream, one aplicator every night for 7 nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Elnaz Saffari
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Elnaz Saffari
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor,Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz 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
Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Saffari
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Kousar Dormitory, South Shariati Ave, Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
elnazsafari82@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Associate Professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
City
Tabriz
Postal code
Phone
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Associate Professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
City
Tabriz
Postal code
Phone
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)