1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the effect of oral traditional Persian medicine product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age, compare with placebo. a triple-blind randomized clinical trial

Protocol summary

Study aim
The main goal:Determining the effect of the oral product of traditional Persian medicine product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age, compare with placebo.
Design
Clinical trial with control group, parallel groups, triple blind, randomized by epidemiologist, on 74 patients.
Settings and conduct
Patients with sexual dysfunction referred to Health College of Persian Medicine in Qom and medical science clinics in Qom, including Rayhane Infertility Center of Nekoui Hospital, who meet the study entry criteria, are selected by the researcher, then the details of the study will be explained by the researcher, then the questionnaire Demographic characteristics and disease information are adjusted and patients are randomly assigned to one of two treatment groups.
Participants/Inclusion and exclusion criteria
1. Women aged 18-50 years 2. The woman being married and her husband being monogamous 3. FSFI women's sexual function index score<28 in the initial evaluation 4. Patients with BMI less than 30 5. Having informed consent to participate in the study
Intervention groups
Intervention group: The patients will be given traditional Persian medicine products containing silk. Silk syrup is taken three times a day for 3 weeks and 10 cc each time. Control group: patients will be given a placebo product. Placebo syrup is taken 10 cc three times a day for 3 weeks.
Main outcome variables
female sexual function, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221017056213N1
Registration date: 2022-12-04, 1401/09/13
Registration timing: registered_while_recruiting

Last update: 2022-12-04, 1401/09/13
Update count: 0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
fatemeh jahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 4075
Email address
fjahani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral traditional Persian medicine product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age, compare with placebo. a triple-blind randomized clinical trial
Public title
Evaluation of the effect of oral product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-50 years The woman being married and her husband being monogamous FSFI women's sexual function index score<28 in the initial evaluation Ability to read, understand and complete the questionnaire People with BMI less than 30 Having informed consent to enter the study
Exclusion criteria:
pregnancy and breastfeeding delaying menstruation for 2 months or more significant clinical findings in physical examination, screening tests or other findings that prevent safe participation in the study, including the presence of any organic, anatomical disease (such as malformation of the anatomy of the external genitalia, spinal cord injuries or related surgery), hormonal in the study group such as diabetes, cerebrovascular disease, liver and kidney function damage, heart disease, hypothyroidism, cancers in history and medical history of psychiatric diseases that are under drug treatment. receiving psychotherapy or other treatments for sexual dysfunction using tobacco, alcohol, drug abuse using any chemical and herbal medicine known to affect libido being participate in another clinical trial study major changes in recent relationships, ongoing or unforeseeable disorder or disturbance that is not related to his sexual dysfunction.
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patient, the researcher (project manager (doctor)) and the statistical consultant will not know about the syrup content and they will be blinded. Only the traditional medicine pharmacist who is responsible for the preparation of Iranian traditional medicine syrup and placebo syrup will know about the content of medicinal syrups. People who meet the inclusion criteria, if they want to participate in the study, after obtaining written informed consent, they will be given the traditional Iranian medicine syrup and placebo, which are in the same packaging and completely similar in terms of appearance, color and aroma. They receive a random face. A special code will be considered for each syrup and will be recorded on the syrup label. Only the pharmacist consultant will know about the drug codes. Medicines will be provided to the doctor and plan administrator and the patient. The code of each syrup specific to each patient will be entered in the patient's file and checklist by the administrator. At the end of the study, the information and checklist form of the patients will be provided to the statistics consultant for statistical analysis, and after the data analysis, the code of syrups will be provided to the administrator and statistics consultant for the final analysis by the pharmaceutical expert.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Street address
No. 83, Shahid Lotfi Niaser, Shahid Lotfi Niaser, Safashehr St., No. 83
City
Qom
Province
Ghoum
Postal code
3716993456
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.MUQ.REC.1401.093

Health conditions studied

1

Description of health condition studied
sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
sexual dysfunction
Timepoint
The beginning of the study, the end of the fourth week from the beginning of the intervention, one month after the end of the intervention
Method of measurement
female sexual function index Questionnaire

2

Description
Quality of Life
Timepoint
The beginning and end of the study
Method of measurement
Quality of life questionnaire with 36 questions

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will be given traditional Persian medicine products containing silk. Silk syrup is taken three times a day for 3 weeks and 10 cc each time.
Category
Treatment - Drugs

2

Description
Control group: Patients will be given a placebo product. Placebo syrup is taken 10 cc three times a day for 3 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health College of Persian Medicine in Qom and Medical Sciences Clinics in Qom, including Reihaneh In
Full name of responsible person
fatemeh jahani
Street address
Qom Faculty of Persian Traditional Medicine , next to Alley 44, 15 Khordad Blvd
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
+98 25 3777 3466
Email
fatima.jahani1370@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Alireza Kohpaei
Street address
No. 8 , Shahid Lotfi Niaser (alley no. 4) , Jihad Danighi Alley , Safashehr St
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
fatemeh jahani
Position
PhD student of traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Persian Medicine of Qom University of Medical Sciences, corner of Alley 44, 15 Khordad Blvd
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
00982537764073-4
Email
fatima.jahani1370@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. fatemeh nojavan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Corner of Alley No.44, Faculty of Persian Traditional Medicine of Qom University of Medical Sciences, 15 Khordad Blvd
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
+98 25 37764073-4
Email
fnojavan@muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
fatemeh jahani
Position
PhD student of traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Persian Medicine of Qom University of Medical Sciences, corner of Alley 44, 15 Khordad Blvd
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
00982537764073-4
Email
fatima.jahani1370@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Data will be sent by researchers upon request. All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
After printing the results of the study
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be used only for use in published research articles and will not be made available to the public in any other way.
From where data/document is obtainable
To receive the desired documents and data, please refer to the Faculty of Traditional Medicine of Qom University of Medical Sciences.
What processes are involved for a request to access data/document
The data will be accessible from the time of announcing the request to the responsible person and proving the scientific documents of the applicant that they are working researchers at the university, as well as reviewing the relevant study and research.
Comments
Loading...