Protocol summary

Study aim
Determining the effect of Melissa capsules on sexual function of postmenopausal women
Design
A clinical trial with a control group. with parallel groups, triple blind, randomized, phase 3 on 100 patients. Excel software is used for randomization.
Settings and conduct
The researcher selects four centers from the comprehensive health service centers affiliated to SBMU located in the north and east of Tehran by simple random sampling, then eligible postmenopausal women are attended. The informed consent form and relevant questionnaires are completed. Women are randomly assigned to groups 1 or 2 using Excel software in the same order as they enter the study and each group is given a medicine. The researcher, the samples, and the statistical consultant are unaware of what medicine each envelope contains except for pharmaceutical consultant. After the completion of the two-month period, the FSFI questionnaire is completed again because it measures sexual function in the previous month, it is completed again one month after the end of the course. Finally, the data is analyzed by a statistical consultant.
Participants/Inclusion and exclusion criteria
in Iranian cases, at least one year had passed since their menses, do not has hormone replacement therapy, has sexual activity, menopausal women and their husband known for no mental illness, no addiction to smoking or drugs, not acquire depression and anxiety, unknown for any chronic diseases, is not allergenic to medicinal plants and gluten, If cases show sensitivity to Melissa capsules, has not used capsules for two days or more, hasn't taken regularly and the person is reluctant to continue the treatment are removed.
Intervention groups
In intervention group, the samples consumed one Melissa capsule daily, and in the control group, the capsule containing dry bread was consumed for two months.
Main outcome variables
Sexual function score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230831059313N1
Registration date: 2023-11-02, 1402/08/11
Registration timing: registered_while_recruiting

Last update: 2023-11-02, 1402/08/11
Update count: 0
Registration date
2023-11-02, 1402/08/11
Registrant information
Name
Hamide Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3669 2645
Email address
hamideahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Melissa officinalis capsule on the sexual function of Menopause women
Public title
Investigating the effect of Melissa officinalis capsule on the sexual function of Menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian. At least be literate in reading and writing. At least one year has passed since their menopause. Have a married life with her husband. Not willing or required to use hormone replacement therapy. According to Miss Menopause don't use any chemical or herbal medicine to treat your problem. have sexual activity. Do not use herbal teas while taking medicines.
Exclusion criteria:
Have speech, hearing or mental disorders that prevent communication with the researcher. Have undergone hysterectomy and ovariectomy, cystocele and rectocele, and mastectomy. Have a history of known chronic diseases such as high blood pressure, diabetes, asthma, weakening the immune system, etc. Her husband of a menopausal woman have sexual problems. Menopausal women and their husbands are known to have mental illness. Addicted to smoking or drugs. A special event or incident that constitutes a crisis in their life, such as the death of a loved one, incurable illness in family members, change of residence, loss of job has occurred since 6 months ago. Have a history of allergy to medicinal plants. Have a history of endometrial cancer and other estrogen-related cancers in first-degree relatives. Have a history of gluten sensitivity.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
First, in order to select health service centers, the researcher needs to select four centers by simple random sampling. Random numbers function of Excel software is used to randomize the samples into intervention and control groups. to this extent, the numbers represented the samples are sorted from 1 to 100 then written in order in the first column and in the next column, the numbers 1 and 2 are randomly placed in front of each sample. Finally, the samples are divided into two groups in the same order as they enter the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a triple-blind randomized clinical study. Therefore, the researcher, the research units, and the statistics consultant professor are not aware of the coding and what sort of medicine each package contains and only the pharmaceutical consultant of the research is aware of the coding of the envelopes and the type of drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Schools of Pharmacy, Midwifery Nursing - Shahid Beheshti University of Medical S
Street address
13th floor, Block A, Headquarters of Ministry of Health, Treatment and Medical Education, Simai Iran St, between South Flamak and Zarafshan, Quds town (west), Tehran
City
Tehran
Province
Tehran
Postal code
ethics@receaech.ac.i
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.074

Health conditions studied

1

Description of health condition studied
Sexual function of Menopause women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual function score in female sexual function index questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and one month after the end of the intervention
Method of measurement
Female Sexual Function Index Questionnaire

Secondary outcomes

1

Description
Sexual satisfaction score
Timepoint
Before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention.
Method of measurement
ّFemale sexual Function Index Questionnaire

Intervention groups

1

Description
Intervention group: In this research, the intervention group consumes Melissa capsules. These capsules contain 500 mg of Melissa plant extract powder. These capsules are prepared in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. In this way, the purchased plant is extracted by the pharmaceutical consultant. It is made into a powder and poured into capsules similar to a placebo and one capsule per day is consumed by a menopausal woman for two months.
Category
Treatment - Drugs

2

Description
Control group: In this study, the control group uses a placebo. Placebo means edible capsules containing dry bread powder And these capsules are adapted to Melissa capsules in terms of shape and size. They are prepared in the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, by the pharmaceutical consultant professor. also, the capsules are placed along side to each other so that they smell similar and then they are provided to the samples in similar envelopes. One capsule is taken daily for two months by a menopausal women.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nader Health Comprehensive Service Center
Full name of responsible person
Panthea Mahdavi
Street address
Esfandani Street, Jashnvare Street, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1654887171
Phone
+98 21 7732 2277
Email
mbsh@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Kadus Comprehensive Health Service Center
Full name of responsible person
Ahmad Ali Dad Khodei
Street address
Sojdeh Street, Jashnvare Street, Tehran Pars
City
Tehran
Province
Tehran
Postal code
1655948843
Phone
+98 21 7770 9141
Email
mbsh@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Comprehensive health service center of Ba'ath al-Nabi
Full name of responsible person
Arin Mansouri
Street address
7th street, 15 meters third, Afsarieh
City
Tehran
Province
Tehran
Postal code
1743643751
Phone
+98 21 7743 0048
Email
shargh.pr@sbmu.ac.ir

4

Recruitment center
Name of recruitment center
Taqavi Comprehensive Health Service Center
Full name of responsible person
Seyed Mehdi Seyed Darabi
Street address
Porzargar Alley, Aghajanlu St., Mujahideen St.,
City
Tehran
Province
Tehran
Postal code
1157714111
Phone
+98 21 3356 4646
Email
shargh.pr@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Building No. 2, Next to Taleghani Hospital, Erabi St., Student Blvd., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamide Ahmadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, The intersection of Hashemi Rafsanjani highway and Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2518
Email
hamide.ahmadi1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Zare
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, The intersection of Hashemi Rafsanjani highway and Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
elhamzare.phd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamide Ahmadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 10, Mousa Abadi Ave., Emam Khomeini Blvd., Ghaleno., Shahre Rey
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 3669 2645
Fax
Email
hamideahmadi@sbmu.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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