Investigation of the effect of Alcea vaginal suppository on the treatment of vaginal atrophy in postmenopausal women.
Design
Clinical trial with control group, with a parallel group design of 60 patients, double blinded, Permuted block randomization
Settings and conduct
The study is conducted randomly and double-blind at the women clinic of Ummol-Banin Hospital in Mashhad. The patient and the investigator are unaware of the type of treatment, but the clinical care provider is aware of the type of treatment with the Alcea suppository or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Married women, and have sexual activity;
Age between 40-65 years;
Complaint of vaginal dryness;
Amenorrhea for at least 12 months, or laboratory confirmation of menopause(FSH>40);
Amenorrhea after surgery and Bilateral Oophorectomy;
Exclusion criteria:
Endometrial cancer or breast cancer or suspicion of it;
Vaginal bleeding with unknown causes;
Vaginal infection;
History of sensitivity to Alcea;
Chronic diseases;
The history of consumption of hormonal products containing estrogen and progesterone in the last month;
The history of vaginal use of stimulants that can cause chronic vaginal itching (scents, moisturizers, soaps)in the last month.
Intervention groups
Intervention group: Alcea vaginal suppository (5%) every night for 2 weeks, followed by every other night administration for a further 6 weeks.
Control group: placebo, vaginal suppository every night for 2 weeks, followed by every other night administration for a further 6 weeks.
All stages of suppository preparation, are carried out by the pharmacist professor at the Traditional Medicine Laboratory. The Alcea angulata is prepared from the Faculty of Agriculture (Voucher number (FUMH-E 1009). The standardization of the suppository is done by the Folin-Ciocalteu method.
Main outcome variables
symptoms of vaginal atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041099N1
Registration date:2019-02-24, 1397/12/05
Registration timing:prospective
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Alieh Kiani Talaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 5550
Email address
kianita941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-02, 1397/12/11
Expected recruitment end date
2019-08-02, 1398/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Alcea vaginal suppository on the treatment of vaginal atrophy in postmenopausal women.
Public title
Effect of Alcea in treatment of vaginal atrophy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women, and have sexual activity;
Age between 40-65 years;
Complaint of vaginal dryness;
Amenorrhea for at least 12 months, or laboratory confirmation of menopause(FSH>40);
Amenorrhea after surgery and Bilateral Oophorectomy;
Exclusion criteria:
Endometrial cancer or breast cancer or suspicion of it;
Vaginal bleeding with unknown causes;
Vaginal infection;
History of sensitivity to the Alcea;
Chronic diseases;
The history of consumption of hormonal products containing estrogen and progesterone in the last month;
The history of vaginal use of stimulants that can cause chronic vaginal itching (scents, moisturizers, soaps) in the last month;
Age
From 40 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization;
Random unit: Individual;
Randomization Tool: block;
How to create a random sequence: From the four blocks, we select one, by accident (Roll of a die), and according to the order, assign the samples to two groups A and B, and so continue until the end we give.
Allocation concealment:This is a double-blind, placebo-controlled study. As the patient and researcher of the project are not aware of the content of the treatment. In both groups, vaginal suppositories are identical in terms of shape, odor, size, and color.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is conducted randomly, double-blind, and controlled by placebo.
Participants are randomly selected and divided into two groups of intervention and control. The intervention group, the Alcea vaginal suppository, and the control group, are given placebo suppositories that are uniform in shape, odor, size and color, so the participants are unaware of the type of treatment.
The researcher will provide Alcea suppository and placebo to clinical care providers, and she distributes them according to the patient's condition. Therefore, only clinical care providers are aware of the type of treatment, and during the treatment, the investigator and the assessor of the outcome, are unaware.
Placebo
Used
Assignment
Parallel
Other design features
To both groups, life style modification of Traditional Persian Medicine, are offered.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences; Shastkola Road.
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.GOUMS.REC.1397.230
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
Symptoms of vaginal atrophy
Timepoint
Before intervention, Eight weeks after intervention
Method of measurement
The most bothersome symptom of vaginal mucosa with Visual Analogue Scale
2
Description
Vaginal superficial cells
Timepoint
Before intervention, Eight weeks after intervention
Method of measurement
vaginal maturation index
3
Description
Vaginal PH
Timepoint
Before intervention, Eight weeks after intervention
Method of measurement
PH meter
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before intervention, Eight weeks after intervention
Method of measurement
Standard Questionnaire for Assessment of Female Sexual function (FSFI)
Intervention groups
1
Description
Intervention group: Alcea vaginal suppository(5%) every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of treatment is 8 weeks. All stages of construction of suppositories are carried out by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. At first, the Alcea angulata dried with Voucher number (FUMH-E 1009) from the Faculty of Agriculture, Ferdowsi University of Mashhad, was prepared and extracted by soaking. Then, 5% of the extract was added to the suppository base (PEG). Standardization of suppositories takes place in Folin–Ciocalteu method in 3 steps.
Category
Treatment - Drugs
2
Description
Control group:placebo, vaginal suppository every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of use is 8 weeks.The placebo suppository containing the suppository base (PEG) made by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. These suppositories are very similar to the Alcea suppositories in terms of shape, size, color and smell.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Women clinic of Omolbanin hospital
Full name of responsible person
Alieh Kiani Talaei
Street address
Omolbanin hospital, Behjat Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178955448
Phone
+98 51 3223 1061
Fax
+98 51 3223 1444
Email
kianita941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammadreza Honarvar
Street address
Golestan University of Medical Sciences; Shastkola Road.
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
Info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Alieh Kiani Talaei
Position
Ph.D student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Golestan University of Medical Sciences; Shastkola Road
City
Gorgan
Province
Golestan
Postal code
9178955448
Phone
+98 51 3869 5550
Email
kianita941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marzieh Gharaaty
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Golestan University of Medical Sciences; Shastkola Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
Gharaaty1387@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Alieh Kianitalaei
Position
Ph.D student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Golestan University of Medical Sciences; Shastkola Road
City
Gorgan
Province
Golestan
Postal code
9178955448
Phone
+98 51 3869 5550
Email
kianita941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of ethical principles and assuring patients that their specifications are not disclosed
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Statistical results
When the data will become available and for how long
2019
To whom data/document is available
Researchers
Under which criteria data/document could be used
Continue the research
From where data/document is obtainable
Golestan University of Medical Sciences
What processes are involved for a request to access data/document
Written request; University agreement; Delivery of information