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The effect of urtica dioica plant vaginal cream on vaginal atrophy and sexual quality of life in menopausal women

Protocol summary

Study aim
Determining the effect of urtica dioica plant vaginal cream on vaginal atrophy and sexual quality of life in menopausal women
Design
Clinical trial with control and placebo groups, with parallel groups, three-way blind, randomized, phase 3 on 102 patients. Www.randomization.com site will be used for randomization.
Settings and conduct
The present study will be performed as a three-group randomized clinical trial on 102 postmenopausal women referring to Gorgan health centers. Sampling will be available. If the score is at least one of the signs of the Vaginal Assessment Scale (VAS) 4 or higher, the research unit selection form for individuals will be completed. Then the person undergoes a gynecological examination and vaginal pH is determined. A sample of vaginal cells will also be taken and sent to a laboratory to determine the vaginal maturation value (VMV). If the vaginal PH is above 5 and the VMV is less than or equal to 55%, the person will be considered as one of the research units. each of the creams has a code that only a pharmacist consultant knows about. Persons will randomly receive one of the 5% nettle vaginal creams, conjugated estrogen and placebo at a dose of one gram every night for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week. Follow-up will be done 4 and 8 weeks after the study.
Participants/Inclusion and exclusion criteria
Iranian and resident of gorgan; Married and sexually active in the past 6 months; Normal menopause; Age 45-60; Normal pap smear; Diagnosis of vaginal atrophy
Intervention groups
The intervention group will receive 5% urtica dioica plant vaginal cream and the control group will receive conjugated estrogen vaginal cream for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week.
Main outcome variables
Vaginal assessment scale (VAS); vaginal PH; Vaginal maturation index (VMI); vaginal maturation value (VMV)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210216050382N1
Registration date: 2021-02-25, 1399/12/07
Registration timing: prospective

Last update: 2021-02-25, 1399/12/07
Update count: 0
Registration date
2021-02-25, 1399/12/07
Registrant information
Name
nahid nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3422 9387
Email address
nazarin982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of urtica dioica plant vaginal cream on vaginal atrophy and sexual quality of life in menopausal women
Public title
The effect of urtica dioica on vaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of gorgan Satisfaction to participate in the study Literacy for reading and writing Married and sexually active in the past 6 months Normal menopause Age 45-60 Normal pap smear Diagnosis of vaginal atrophy (score of 4 or more on the vaginal atrophy questionnaire and vaginal PH greater than 5 and VMV equal to or less than 55)
Exclusion criteria:
Use of phytoestrogens (soy, flaxseed, red clover, fennel, nettle) one month before the start of the study Hormone therapy for 6 months before the start of the study Abnormal vaginal bleeding (spotting, pink or brown discharge, or obvious bleeding) Specific medical diseases (history of ovarian, breast and endometrial cancer - cardiovascular disease - history of thromboembolism or thrombophlebitis - history of coagulation diseases - history of ischemic stroke - migraine headaches - seizures - uterine leiomyoma - endometriosis - hypertension - diabetes - hyperlipidemia- liver and gallbladder disease - chronic kidney disease - tobacco use history - genitourinary abnormalities (uterine unicorn, bicornuate, double and septate) Use of certain medications (hormonal medications - moisturizers and vaginal gels - antihypertensive drugs - diuretics - antidepressants - antipsychotics - lithium - antihistamines - barbiturates - narcotics - benzodiazepines - hallucinogens - amphetamine – cocaine- digoxin) Vaginal infections (candida-trichomonas-bacterial vaginosis-std-herpes) History of estrogen sensitivity (breast pain, breast tenderness and sensation, spotting, itching, burning, redness) History of nettle sensitivity
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of postmenopausal women to three groups of urtica dioica vaginal cream, conjugated estrogen and placebo will be simple random with random sequence created by www.randomization.com. The random sequence created by the site is provided to the pharmacist consulting professor so that the creams are labeled with one of the codes A, B and C without informing the other members of the research team. After the entry of each person with the conditions of inclusion in the study, according to the above random sequence, one of the creams A, B and C will be delivered to him.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Urtica dioica vaginal cream, placebo and conjugated estrogen will be poured into exactly the same tubes. The creams are similar in shape and color and only the pharmacist consulting professor will know the codes assigned 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 Mashhad University of Medical Sciences-School of Nursing and Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.092

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, 4 and 8 weeks after the intervention
Method of measurement
Vaginal assessment scale

2

Description
Vaginal PH
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
PH-indicator strips

3

Description
Vaginal maturation index
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
Pathological examination

4

Description
Vaginal maturation value
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
Pathological examination

Secondary outcomes

1

Description
The sexual quality of life
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
The sexual quality of life female questionaire

Intervention groups

1

Description
Intervention group: Vaginal cream 5. urtica dioica plant made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram (Equivalent to 50 mg of extract) will be used every night. In clinical trials, a dose of 600 mg has been used for allergic rhinitis, and 600-1200 mg daily for 6-9 weeks for benign prostatic hyperplasia. The average oral lethal dose in rats was estimated to be more than 30 g / kg for aqueous leaf extract and 1.3 g / kg for roots.
Category
Treatment - Drugs

2

Description
Control group: Conjugated estrogen vaginal cream for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used.
Category
Treatment - Drugs

3

Description
Control group: Placebo vaginal cream containing Farabi cream base made in the Department of Medicinal Plants Pharmacology of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan health centers
Full name of responsible person
Morteza Gholami
Street address
Razi St, Shahid Rajaei St
City
Gorgan
Province
Golestan
Postal code
4941943585
Phone
+98 17 3242 3370
Email
nazarin982@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Bahraini
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nazarin982@mums.ac.ir
Web page address
https://nurse.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
Nahid Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nazarin982@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
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah Street
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
Nahid Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nazarin982@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
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