Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function of women with diabetes type 2,a randomized double-blinded clinical trial
Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function in women with diabetes type 2
Design
Two arm parallel groups randomized clinical trial, double blinded, phase 2 on 100 patients
Settings and conduct
Diabetic women aged 25-55 referred to health and medical centers of Kashan University of Medical Sciences who have sexual dysfunction are referred to the researcher.
Participants/Inclusion and exclusion criteria
Including Criteria
1. Married women with type 2 diabetes and sexual dysfunction
2. HBA1C between 7.1 & 8.5
3. Age between 25 & 55 years
Excluding criteria
1. Diagnosis of current chronic diseases affecting sexual function in the patient or his wife during the study
2. taking drugs that affect sexual function
3. The occurrence of an unfortunate incident such as the loss of partner or close relative during the study
5. Getting pregnant
6. Menopause
Intervention groups
The intervention group received 500 mg tablets of herbal combination three times a day for 8 weeks and the placebo group received placebo tablets with the same order. During this period, patients are followed up by telephone once a week regarding the correct use of medicine and possible side effects. After entering the study, patients are visited after 4 weeks and at the end of 2 months.
Main outcome variables
At the beginning and end of the study, Questionnaire of the Women's Sexual Performance Index (FSFI), Global Sexual Satisfaction Scale (GMSEX) and General Health Questionnaire (GHQ-12) will be filled, and the tests will include fasting blood sugar (FBS), two hours postprandial blood sugar (2PPBS).hemoglobin A1C will be repeated and possible drug side effects will be recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050457N2
Registration date:2023-05-08, 1402/02/18
Registration timing:prospective
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Fatemeh Shirvanizade arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5472 5800
Email address
dr.shirvanizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function of women with diabetes type 2,a randomized double-blinded clinical trial
Public title
Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function 0fwomen with diabetes type 2,a randomized double-blinded clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with type 2 diabetes and sexual dysfunction
HBA1C between 7.1 & 8.53.
Age between 25 & 55 years
diabetic patients should not have systemic diseases such as liver failure, kidney failure, heart failure, thyroid failure, central nervous system disorders, or retinopathy.
Absence of pregnancy and breastfeeding
Absence of Ovariectomy history and Ovarian agenesis
Having a stable life with his wife
Married for at least one year
Exclusion criteria:
Diagnosis of having chronic diseases affecting sexual function in the patient or his partner during the study (such as cardiovascular or mental or thyroid disorders, cancers)
taking drugs that affect sexual performance
The occurrence of an unfortunate incident such as the loss of partner or close relative during the study
vaginal bleeding, dyspareunia, vaginismus
Getting pregnant
Menopause
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
People are randomly divided to drug and placebo groups. The drug group received 500 mg herbal tablets three times a day, and the placebo group received placebo tablets with the same prescription.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group received 500 mg herbal tablets three times a day, and the placebo group received placebo tablets with the same order.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Dr. Rahnamun Hospital, Yazd
Street address
Motahari Blvd., end of 1st Hekmat Alley
City
Aran and bidgol
Province
Isfehan
Postal code
8741646949
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SSU.SRH.REC.1401.026
Health conditions studied
1
Description of health condition studied
Type 2 diabetes with sexual dysfunctionٍ
ICD-10 code
E11.8
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications
Primary outcomes
1
Description
Sexual function
Timepoint
At the beginning of the study and after two months of taking the drug
Method of measurement
Questionnaire
Secondary outcomes
1
Description
FBS
Timepoint
At the beginning of the study and 60 days after starting to take the drug
Method of measurement
Lab test
2
Description
2 hours post prandial blood sugar
Timepoint
At the beginning of the study and 60 days after starting to take the drug
Method of measurement
Lab test
3
Description
HB A1C
Timepoint
At the beginning of the study and 60 days after starting to take the drug
Method of measurement
Lab test
4
Description
Mental health
Timepoint
At the beginning of the study and 60 days after starting to take the drug
Method of measurement
questionare
Intervention groups
1
Description
The intervention group consumes 500 mg herbal tablets three times a day. The drug is prescribed to patients for 8 weeks by a non-researcher, based on masking. The raw materials of this product, which include carrot seeds and fenugreek seeds, are first subjected to quality control tests, including the amount of waste particles, moisture, total ash, and determining the amount of an indicator substance or total essential oil. After determining the quality of each plant, 250 mg of 5% fenugreek seed extract (Fenugreek seed extract) is mixed with 250 mg of carrot seed powder and then sieved and produced in the form of 500 mg tablets with a press machine.
Category
Treatment - Drugs
2
Description
The control group consumes 500 mg placebo tablets made of starch but with a completely similar appearance to the drug three times a day. The placebo is prescribed to patients for 8 weeks by a non-researcher.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes center of Aran & Bidgol and Kashan cities
Full name of responsible person
Fatemeh Shirvanizadeh Arani
Street address
Hekmat1 Alley, Motahari Blvd
City
Aran and bidgol,
Province
Isfehan
Postal code
8741646949
Phone
+98 913 362 0393
Email
dr.shirvanizade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi AbarQoui
Street address
1st Hekmat Alley ,Motahari Blvd
City
Aran and bidgol
Province
Isfehan
Postal code
8741646949
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh shirvanizadeh Arani
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
1st Hekmat Alley.Motahari blvd
City
Aran and bidgol
Province
Isfehan
Postal code
8741646949
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme shirvani zade Arani
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hekmat1 Alley, Motahari Blvd
City
Aran and bidgol
Province
Isfehan
Postal code
8741756791
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh shirvanizadeh Arani
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hekmat1 Alley, Motahari blvd
City
Aran and bidgol
Province
Isfehan
Postal code
8741646949
Phone
+98 31 5472 5800
Email
dr.shirvanizade@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will publish in the form of a thesis
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
With an official letter from the Research and Technology Vice-Chancellor of Yazd University of Medical Sciences
From where data/document is obtainable
Fatemeh Shirvanizadeh, Faculty of Persian Medicine, Ardakan, Yazd
What processes are involved for a request to access data/document
Refer to the research and technology unit of Yazd University of Medical Sciences and ask for it