General purpose:Comparing the Effect of Centella Asiatica and Conjugated Estrogen Vaginal Cream for the Treatment of Vaginal Atrophy in Postmenopausal Women
specific objecvtive: Comparison of vaginal atrophy Improvement before intervention as well as 4 and 8 weeks after intervention in Centella Asiatica group
Comparison of vaginal atrophy Improvement before intervention as well as 4 and 8 weeks after intervention in Conjugated Estrogen group
Comparison of vaginal atrophy Improvement before intervention as well as 4 and 8 weeks after intervention in two groups
Design
Single-blind randomized controlled Clinical trial
Settings and conduct
Selected health centers and gynecologic clinics of hospitals affiliated to Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Being Iranian and residence of Mashhad,Iran
Married and Sexually active women,
age range of 40–65 years,
Having reading and writing skills,
Having amenorrhea for at least 12 months , or 6 months amenorrhea with FSH>40 or an endometrial thickness of 5 mm or less as determined by trans vaginal ultrasonography,
Getting a score of ≥ 65 on the visual analogue scale (VAS) , Having at least one symptom of physical examination scale ,having a vaginal pHvalue > 5 , Having vaginal maturation index more than 50 percent
Intervention groups
The intervention group will receive 1% Centella Asiatica Vaginal Cream daily for 8 weeks and the usual treatment group will receive 0.625 mg of conjugated estrogen cream daily for two weeks,and then twice a week.
Comparing the effect of Centella Asiatica and Conjugated estrogen vaginal cream for the treatment of vaginal atrophy in postmenopausal women
Public title
Comparing the effect of Centella Asiatica and Conjugated estrogen vaginal cream for the treatment of vaginal atrophy in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian and residence of Mashhad,Iran
Married and Sexually active women
age range of 40–65 years
Having reading and writing skills
Having amenorrhea for at least 12 months , or 6 months amenorrhea with FSH>40 or an endometrial thickness of 5 mm or less as determined by transvaginal ultrasonography
Getting a score of ≥ 65 on the visual analogue scale (VAS) and having at least one symptom of physical examination scale and a vaginal pH value > 5 and Vaginal maturation index(VMV) < 50
Exclusion criteria:
Current or suspected endometrial cancer
Suspected genital cancer
Reproductive system abnormalities
Genital bleeding with unknown causes
Use of anti hypertensive drugs
Smoking or passing at least 3 months after smoking ceasation
Vaginal infections
Use of hormone replacement therapy 8 weeks before the study
Use of foods containing 40 to 60 grams (about one tbsp) of phyto estrogen (such as red clover, flaxseeds and soy beans) in the past month
Having conditions such as diabetes, chronic renal disease, arthritis, cardiovascular diseases, and active disease in the liver or gallbladder
Age
From 40 years old to 65 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation will be done by typing on the code assigned to the Centella Asiatica cream and the conjugated estrogen cream. These codes are wrriten on two peaces of papers which are place in one box. At the first day of sampling, the researcher takes one of the papers inside the box , which will be assigned to the first sample,and the other code will be allocated to the next sample(control). In this way, subjects will be assigned to intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Similarity of creams in terms of shape, color and size of cream-containing shells
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
شماره IR.MUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied
Vaginal Atrophy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
vaginal pH
Timepoint
Beforeas well as 4 and 8 weeks after starting the intervention
Method of measurement
Merk PH-indicator strips
2
Description
vaginal maturation value (VMV)
Timepoint
Beforeas well as 4 and 8 weeks after starting the intervention
Method of measurement
Pathological examination
3
Description
vaginal maturation index (VMI)
Timepoint
Beforeas well as 4 and 8 weeks after starting the intervention
Method of measurement
Pathological examination
Secondary outcomes
1
Description
most bothersome symptom(MBS)
Timepoint
Beforeas well as 4 and 8 weeks after starting the intervention
Method of measurement
Visual Analogue Scale
2
Description
Vaginal physical examination
Timepoint
Beforeas well as 4 and 8 weeks after starting the intervention
Method of measurement
physical examination scale
Intervention groups
1
Description
Intervention group: Centlla Asiatica Cream 1% , daily for 8 weeks as an applicator, produced in the laboratory of school of Pharmacy, Mashhad University of Medical Sciences, Mashhad,Iran
Category
Treatment - Drugs
2
Description
Control group: Conjucated estrogen cream
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Nafise Saghafi
Street address
Ahmad Abad Ave,Ghaem Hospital,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
SaghafiN@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
prof.Mohsen Tafaghodi
Street address
school of Pharmacy,University campus(pardis),Vakil Abad Blvd,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
TafaghodiM@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
Mahnaz Rahmanpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.48,,Ladan 22 Blvd.,Vakil Abad Ave.,Mashad
City
Mashad
Province
Razavi Khorasan
Postal code
9179965789
Phone
+98 51 3891 5478
Fax
Email
Rahmanpourm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
prof. Robab Latifnejad Roudsari
Position
Associate Professor in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Mashhad University of Medical Sciences,Mashhad,Iran
City
Mashad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 38413007051
Fax
Email
latifnejadr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahnaz Rahmanpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.48,,Ladan 22 Blvd.,Vakil Abad Ave.,Mashad
City
Mashad
Province
Razavi Khorasan
Postal code
9179965789
Phone
+98 51 3891 5478
Fax
Email
Rahmanpourm951@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