Comparison of the effect and comparative study of the effect of soy and fish oil tablets in control of hot flash and night sweats in terms of frequency and severity of symptoms of sexual disorders and sleep disorders in 45-64 year old menopausal and pre-menopausal women
Design
A randomized controlled clinical trial with double blinded parallel groups
Settings and conduct
The sampling method in this study was random sampling among patients referred to Rasoul Akram Clinics and 159 patients were selected randomly based on inclusion and exclusion criteria.The drugs were placed in two envelopes that the researcher did not know about the contents . In the three groups, hot flash were compared in terms of frequency and severity.
Participants/Inclusion and exclusion criteria
The study population consisted of 159 women referred to Hazrat Rasoul Hospital who were evaluated according to inclusion and exclusion criteria.
Inclusion criteria:
Ages between 45 and 64 years
Not allergic to soy and fish liver pills
Having informed consent for inclusion.
Exclusion criteria:
Lack of reading and writing skills and unable to answer questions
No phone calls to follow up
Having a history of more than 10 years of menopause
Contraindications to hormone therapy include suspected or diagnosed cancer.
Intervention groups
The intervention in the groups consisted of soybean oil, fish liver oil and no drug group.The soybean group received one soybean pills containing 500mg of pure soybean extract daily, and the fish oil group received one fish liver oil pills daily containing 1000mg of fish oil and 180 mg eicosapentaenoic acid and 120mg of docosahexaenoic acid for three months. The third group didnot receive drugs.
Main outcome variables
In the three study groups, night sweats, hot flash frequency and severity of expression, sexual dysfunction and sleep disorders as well as possible side effects determined were compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200222046584N1
Registration date:2020-03-19, 1398/12/29
Registration timing:retrospective
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Bahareh Purzand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2658
Email address
bahareh.purzand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-10-02, 1398/07/10
Actual recruitment start date
2018-10-02, 1397/07/10
Actual recruitment end date
2019-10-02, 1398/07/10
Trial completion date
2019-10-02, 1398/07/10
Scientific title
The effect of Soybean and Fish oil tablets on control of hot flash, sexual and sleep disorders in pre-menopausal and menopausal women 45-64 years old
Public title
Effect of soybean and fish liver oil on control of hot flashes, sexual disorders and sleep disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 45 and 64 years
Not allergic to soy and fish liver pills
Having informed consent for inclusion
Exclusion criteria:
Lack of reading and writing skills and unable to answer questions
No phone calls to follow up
Having a history of more than 10 years of menopause
Concomitant use of sulfanamides, methotrexate, triamethrenone, sulfasalazine, estrogen, phenytoin, anti-anxiety and antidepressants, daily chemicals and multivitamins, aspirin and painkillers
Hormone therapy and OCP use over the past 3 months
Use of complementary herbs to remove vasomotor symptoms over the past month
Contraindications to hormone therapy include suspected or diagnosed cancer
Age
From 45 years old to 64 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
159
Actual sample size reached:
159
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study is simple random sampling. Patients were randomly divided into three groups(Decussate)
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were placed in two envelopes that the researcher did not know about the contents of the envelopes and had A and B written on them.The intervention in the groups consisted of soybean oil, fish liver oil . In the three groups, hot flash and night sweats were compared in terms of frequency and severity, sex and sleep disorders, as well as potential adverse effects.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Vice Chancellor for International affairs, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2019-10-23, 1398/08/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.9511290004
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Comparison of the effect of soy tablets and fish liver oil on TSH level
Timepoint
Before and after the intervention
Method of measurement
TSH measurement in blood
2
Description
Comparison of the effect of soy and liver oil pill on lipid profile
Timepoint
Before and after the intervention
Method of measurement
lipid profile measurement in blood
3
Description
Measuring the number of hot flashes
Timepoint
Before and after the intervention
Method of measurement
Patient MRS questionnaire
4
Description
Measuring the number of times a patient wakes up
Timepoint
Before and after the intervention
Method of measurement
Patient MRS questionnaire
5
Description
Patient's sexual reluctance
Timepoint
Before and after the intervention
Method of measurement
Patient MRS questionnaire
6
Description
Vaginal dryness
Timepoint
Before and after the intervention
Method of measurement
Patient MRS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: Patients receive soy pills.
Category
Prevention
2
Description
Intervention group: Patients receive fish liver oil pills.