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Randomize comparison of vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository for vulvovaginal candidiasis treatment

Protocol summary

Study aim
Randomize comparison vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository with vaginal clotrimazole for vulvovaginal candidiasis treatment
Design
This study is a single blind randomized parallel clinical trial
Settings and conduct
This study was performed in Imam Ali Educational and Medical Clinic in Shahrekord
Participants/Inclusion and exclusion criteria
Inclusion criteria :Diagnosis of candidiasis infection , women aged 18 to 50 years,be married, lack of sensitivity to cuminum cyminum herbal composition, lack of sensitivity to clotrimazol , signature of consent to participate in the study Exclusion criteria: pregnancy, lactation, menopause, underlying diseases,Allergy to cumin , Allergy to clotrimazole , forgetting one dose or more, the patient's unwillingness to continue treatment, menstruation during the study, abnormal uterine bleeding
Intervention groups
1. Cuminum cyminum essential oil suppository 2. Placebo suppository
Main outcome variables
Symptoms of candidal vaginitis (including itching, burning, vaginal redness, inflammation, vaginal discharge) 2. Symptoms of candidal vaginitis (including vaginal erythema, sticky white cheesy discharge, inflammation) 3. Possible side effects of drugs are compared in both therapies groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150706023084N11
Registration date: 2021-10-10, 1400/07/18
Registration timing: registered_while_recruiting

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-05, 1400/07/13
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomize comparison of vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository for vulvovaginal candidiasis treatment
Public title
Randomize comparison of vaginal suppository containing cuminum cyminum essential oil with vaginal clotrimazole versus placebo vaginal suppository for vulvovaginal candidiasis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 - 50 years old Being married Signature of consent Diagnosis of candidiasis infection lack of sensitivity to cuminum cyminum or clotrimazole
Exclusion criteria:
Pregnancy lactation menopause Underlying diseases Menstruation during the study Forget one dose or more of medication Allergy to clotrimazole or cuminum cyminum suppository The patient's unwillingness to continue treatment Abnormal uterine bleeding
Age
From 18 years old to 50 years old
Gender
Female
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
vaginal suppositories of cuminum cyminum and placebo were made by the researcher and were placed in aluminum foils individually , and everyone except the researcher was unaware of the composition of these drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Medical Sciences, Tehran, Pharmacy and Pharmaceutical Sciences branches
Street address
Azad University of Medical Sciences , Pharmacy and Pharmaceutical Sciences Branch , Yakhchal St., Gholhak, Dr. Shariati St. Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.IAU.PS.REC.1399.169

Health conditions studied

1

Description of health condition studied
Candidiasis vulvovaginitis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere

Primary outcomes

1

Description
Itching
Timepoint
Beginning of the study - 7 days after the start of the study
Method of measurement
Questionnaire - completing a checklist to evaluate the symptoms of candidal vaginitis and then compare the frequency of symptoms of candidial vaginitis within and between the two treatment groups

2

Description
discharge
Timepoint
Beginning of the study - 7 days after the start of the study
Method of measurement
Questionnaire

3

Description
Inflammation
Timepoint
Beginning of the study - 7 days after the start of the study
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: consist of 30 people who each receive a 2 gram vaginal suppository containing 0.1 cc of cuminum cyminum essential oil along with clotrimazole vaginal suppository daily for seven days (clotrimazole at night and cuminum cyminum suppository in the morning or noon). Cuminum cyminum suppository is based on polyethylene glycol 1000 and 4000 at the rate of 80% and 20% which is made in Tehran Azad University of Medical Sciences, Department of Pharmacy and Pharmaceutical Sciences. Participants will be explained how to use the drug at the beginning of the study .
Category
Treatment - Drugs

2

Description
Control group: Including 30 patients, each receiving a clotrimazole vaginal suppository and a placebo suppository daily for seven days (clotrimazole at night and placebo in the morning or at noon).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Clinic in Shahrekord
Full name of responsible person
Fatemeh Sadat Abtahi
Street address
Unit 26, No. ,Nasser Tanha Alley, Berezenr St. , 45 metri Golshahr St,
City
karaj
Province
Alborz
Postal code
3198747447
Phone
+98 26 3460 0554
Email
fatemehabtahi21@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Tehran islamic azad university of medical science, Khaghani street, Dr shariati street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
info@iau.ac.ir
Web page address
http://iaups.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
FatemehSadat Abtahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 26, No 41, Nasser Tanha Alley, Berezent St. , 45metri Golshahr St.
City
Karaj
Province
Alborz
Postal code
3198747447
Phone
+98 26 3460 0554
Email
fatemehabtahi21@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Sadat Abtahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
unit26, No41,Nasser Tanha Alley, Berezent St.,45 metri Golshahr St.
City
karaj
Province
Alborz
Postal code
3198747447
Phone
+98 26 3460 0554
Email
fatemehabtahi21@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Maryam Shiee Morteza
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Shariati St., Gholhak, Yakhchal St., Islamic Azad University of pharmaceutical sciences Branch
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
Email
shiehmorteza@iaups.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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