Comparison of the effectiveness of Basil vaginal cream and placebo on vaginal atrophy in postmenopausal women
Design
The clinical trial with control and placebo, triple-blinded, randomized phase 2, on 60 patients. Randomization will be done using the website www.randomization.ir
Settings and conduct
Setting: healthcare centers of Rasht; Study population: 60 postmenopausal women referring to healthcare centers of Rasht; Blinding: triple-blind ; Blinding description: Basil vaginal cream and placebo will be poured into completely identical tubes. The creams will be similar in shape and color, and only the supervising pharmacist will be aware of the assigned codes to the creams.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI less than 30; married and being sexually active in the past 6 months; natural menopause; normal Pap smear; diagnosis of vaginal atrophy.
Exclusion criteria: use of phytoestrogens; hormone therapy; abnormal vaginal bleeding; specific medical conditions; history of severe depression.
Intervention groups
Intervention Group: 5% basil vaginal cream manufactured in the Pharmacology of Medicinal Plants Department at Mashhad University of Medical Sciences will be used for 8 weeks, with every night for the first two weeks and one night in between for the next 6 weeks, with a dosage of 5 grams per night.
Control Group: Placebo vaginal cream containing the cream base from Pharab's preparation manufactured in the Pharmacology of Medicinal Plants Department at Mashhad University of Medical Sciences will be used for 8 weeks, with every night for the first two weeks and one night in between for the next 6 weeks, with a dosage of 5 grams per night.
Main outcome variables
The Vaginal Assessment Scale (VAS), vaginal pH, Vaginal Maturation Index (VMI), and Vaginal Maturation Value (VMV)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061257N1
Registration date:2024-04-05, 1403/01/17
Registration timing:prospective
Last update:2024-04-05, 1403/01/17
Update count:0
Registration date
2024-04-05, 1403/01/17
Registrant information
Name
Fatemeh Razavi Soofiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6727
Email address
razavisf4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using ocimum basilicum vaginal cream compared to placebo on vaginal atrophy in menopausal women: A randomized clinical trial study
Public title
The effect of Basil on vaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian and residing in Rasht
Satisfaction with participating in the study
Body mass index less than 30
Reading and writing literacy
Married and having had sexual activity in the past 6 months
Natural menopause
Aged 45-60 years
Normal pap smear
Diagnosis of vaginal atrophy
Exclusion criteria:
Using phytoestrogens one month before the start of the study
Hormone therapy in the past 6 months before the start of the study
Abnormal vaginal bleeding
Specific medical conditions
Use of specific medications
Vaginal infections
History of cancer and estrogen-related diseases
History of severe anxiety and depression
Sensitivity to basil
Visit due to complaints of vaginal atrophy and request for treatment
Age
From 45 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Menopausal women will be randomly allocated to two groups, Basil vaginal cream and placebo, using a random sequence generated by the website www.randomization.com and random block design (blocks of size six). We will generate a random sequence using random blocks, and this sequence will be written orderly on paper. Each number from 1 to 60 will be assigned to each part of the sequence. These numbers will be attached to the tubes of Basil vaginal cream and placebo. This task will be performed by the supervising pharmacist, and the respective codes will remain with them until the end of the study and will be provided to the researcher when entering data into the software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Basil vaginal cream and placebo will be poured into completely identical tubes. The creams will be similar in shape and color, and only the supervising pharmacist will be aware of the assigned codes to the creams
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.128
Health conditions studied
1
Description of health condition studied
Vaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
Mental symptoms of vaginal atrophy
Timepoint
Before the study, and 8 weeks after the intervention
Method of measurement
Vaginal assessment scale
2
Description
Vaginal PH
Timepoint
Before the study, and 8 weeks after the intervention
Method of measurement
PH-indicator strips
3
Description
Vaginal maturation index
Timepoint
Before the study, and 8 weeks after the intervention
Method of measurement
Pathological examination
4
Description
Vaginal maturation value
Timepoint
Before the study, and 8 weeks after the intervention
Method of measurement
Pathological examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Basil vaginal cream 5%, manufactured in the Pharmacology of Medicinal Plants Department at Mashhad University of Medical Sciences. It will be used for 8 weeks, with every night for the first two weeks and every other night for the next 6 weeks, with a dosage of 5 grams per night.
Category
Treatment - Drugs
2
Description
Control group: Placebo vaginal cream containing the cream base from Pharab's preparation manufactured in the Pharmacology of Medicinal Plants Department at Mashhad University of Medical Sciences. It will be used for 8 weeks, with every night for the first two weeks and every other night for the next 6 weeks, with a dosage of 5 grams per night
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht's health centers
Full name of responsible person
Jaleh Mortazavi
Street address
At the corner of Mirdamadi street; Saadi street
City
Rasht
Province
Guilan
Postal code
7946641576
Phone
+98 13 3312 4140
Email
Rashthc@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahmood Shabestary
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
فاطمه رضوی صوفیانی
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razavisf4012@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Razavi Soofiani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Razavisf4012@mums.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