Comparison of the effects of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil with conjugated estrogen vaginal cream and placebo on vaginal atrophy and sexual function of postmenopausal women.
To compare the effect of Persicaria hydropiper vaginal cream; conjugated estrogen vaginal cream and placebo on vaginal atrophy and sexual function of postmenopausal women.
Design
The clinical trial with two intervention and a control groups, parallel design, double-blind, randomized, phase 3 on 111 patients. The method of randomized permutation blocks with random block sizes of 6, 9 and 12 (using the table related to random permutations) is used for randomization.
Settings and conduct
Place of study: Health center number 12, Ahvaz city; Study population: menopausal women referring to health center number 12; Blinding: double blind, in which the tube of vaginal creams will be marked as A, B and C by the pharmacist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Passing at least one year since the last menstruation; sexual function index score less than 26.
Exclusion criteria: People with or suspected of endometrial and breast cancer;
abnormal bleeding
Intervention groups
Intervention group 1: blue pepper vaginal cream based on coconut oil and sesame oil 0.5 g 5%, for 12 weeks;
Intervention group 2: conjugated estrogen vaginal cream 0.625 milligram, one milligram, for 12 weeks;
Control group: placebo vaginal cream, 12 weeks duration.
Main outcome variables
Overall score of objective and subjective assessment of vaginal atrophy; vaginal cell maturation index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240207060932N1
Registration date:2024-03-03, 1402/12/13
Registration timing:prospective
Last update:2024-03-03, 1402/12/13
Update count:0
Registration date
2024-03-03, 1402/12/13
Registrant information
Name
Mahdieh GHorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3722 6281
Email address
ghorbani.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil with conjugated estrogen vaginal cream and placebo on vaginal atrophy and sexual function of postmenopausal women.
Public title
The effect of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil on vaginal atrophy and sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have had at least one year since their last menstruation or have an FSH test of more than 40 international units
Age range 45-65 years old
Being sexually active (the participant and his wife)
The ultrasound results of the uterus and ovaries are normal
Sexual function index score less than 26.5
Having At least two signs of vaginal atrophy through objective evaluation of the vagina
Normality of the results of clinical breast examination
Exclusion criteria:
People with or suspected of endometrial and breast cancer and undergoing chemotherapy
Abnormal bleeding
vaginal infection
diabetes
cardiovascular disease
chronic kidney disease
active hepatobiliary disease
arthritis
mental illness
People under hormone therapy in the last 12 weeks
People treated with non-hormonal drugs for vaginal atrophy during the last 8 weeks
A history of unusual severe drug reactions to medicinal plants
taking blood pressure drugs
vaginal gels and lubricants
thiazide diuretics
antihistamines
antidepressants
lithium
digoxin
psychoactive drugs
danazol
benzodiazepines
barbiturates
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with random block sizes of 6, 9 and 12 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed envelopes. Also, in order to reduce the creation of selection bias, allocation concealment will be done using unique codes allocated to individuals.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the participants in this research will be completely unaware of the type of treatment (Persicaria hydropiper vaginal cream, conjugated estrogen vaginal cream and placebo vaginal creams). In this way, the tube of vaginal creams will be marked as A, B and C in the same packaging by the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Associate Professor of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, Daneshgahi town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-01-23, 1402/11/03
Ethics committee reference number
IR.AJUMS.REC.1402.560
Health conditions studied
1
Description of health condition studied
Vaginal atrophy in postmenopausal women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
2
Description of health condition studied
sexual function of postmenopausal women
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Subjective, objective assessment of vaginal atrophy
Timepoint
At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment
Method of measurement
Questionnaire for subjective and objective evaluation of vaginal atrophy and experimental investigation
2
Description
Maturation percentage of vaginal cells
Timepoint
Before intervention, after intervention
Method of measurement
Based on Meisel's formula
3
Description
Vaginal acidity
Timepoint
Before intervention, after intervention
Method of measurement
PH gauge
Secondary outcomes
1
Description
Sexual function
Timepoint
At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment
Method of measurement
Female Sexual Function Index-questionnaire
Intervention groups
1
Description
Intervention group 1 (Standard treatment group): conjugated estrogen vaginal cream 0.625 mg, one mg for 12 weeks (the first two weeks every night and the next ten weeks twice a week), Luqman Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group: Persicaria hydropiper vaginal cream based on coconut oil and sesame oil 5%, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week)
Category
Treatment - Drugs
3
Description
Control group: placebo vaginal cream, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center number 12
Full name of responsible person
Mahdieh Ghorbani
Street address
Comprehensive health service center No. 12 Ahvaz (Zargan)
City
Ahvaz
Province
Khouzestan
Postal code
6145818177
Phone
+98 61 3447 6997
Email
mail.m2018q@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakir Kish
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://behsan.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdieh Ghorbani
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
mail.m2018q@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdieh Ghorbani
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 54 3722 6281
Email
mail.m2018q@gmail.com
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