Protocol summary

Study aim
To assess the effect of combined vaginal cream (including honey, olive oil, and propolis) and oral contraceptive pill versus placebo with on treatment of functional cyst of ovary
Design
This is a randomized clinical trial, phase III, in which 60 eligible patients will be randomly assigned to the intervention and control groups.
Settings and conduct
The eligible patients with cervicitis referring to the Health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 49 years, Functional cyst of ovary, Cyst of ovary less than 6 cm, Exclusion criteria: Pregnancy or breastfeeding, Complex raptured cyst, Taking antibiotic or immunosuppressive medications to vaginal drugs in the past 2 weeks, Abnormal uterine bleedings, Liver, renal, hematologic, or central nerves system diseases or diabetes or immunodeficiency syndrome
Intervention groups
Intervention group 1: Combined vaginal cream (containing honey, olive, propolis) every night for 21 nights and after menstruation repeated for 21 nights Intervention group 2: Oral contraceptive pill every night for 21 nights and after menstruation repeated for 21 nights Control group: Receiving no treatment.
Main outcome variables
Primary outcome: Clinical symptoms, size of the ovarian cyst

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N384
Registration date: 2021-02-16, 1399/11/28
Registration timing: prospective

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined vaginal cream (including honey, olive oil, and propolis) and oral contraceptive pill versus placebo with on treatment of functional cyst of ovary: a randomized clinical trial
Public title
Effect of combined vaginal cream (including honey, olive oil, and propolis) and oral contraceptive pill versus placebo with on treatment of functional cyst of ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 49 years, Functional cyst of ovary, Cyst of ovary less than 6 cm,
Exclusion criteria:
Pregnancy or breastfeeding, Complex raptured cyst, Taking antibiotic or immunosuppressive medications to vaginal drugs in the past 2 weeks, Abnormal uterine bleedings, Liver, renal, hematologic, or central nerves system diseases or diabetes or immunodeficiency syndrome
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.UMSHA.REC.1399.901

Health conditions studied

1

Description of health condition studied
Cyst of ovary
ICD-10 code
N83.0
ICD-10 code description
Follicular cyst of ovary

Primary outcomes

1

Description
Clinical symptoms
Timepoint
Before the intervention and 2 months later
Method of measurement
By taking history and clinical examination

2

Description
Size of the ovarian cyst
Timepoint
Before the intervention and 2 months later
Method of measurement
By ultrasonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Combined vaginal cream (containing honey, olive, propolis) every night for 21 nights and after menstruation repeated for 21 nights
Category
Treatment - Drugs

2

Description
Intervention group 2: Oral contraceptive pill every night for 21 nights and after menstruation repeated for 21 nights
Category
Treatment - Drugs

3

Description
Control group: Receiving no treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers in Hamadan city
Full name of responsible person
Arezoo Shayan
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Masoomi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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
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