The goal of research is comparison of the effect of fenugreek seed, Flaxseed and soy on menopausal depression.
A prospective randomize control trial double blind(cases and sampler will be blind) will conduct on 120 women in menopause age that will assign to equal four groups : Fenugreek seed group (6g daily ), Flaxseed group (25 g daily ) , Soy group ( 25 g daily ) and sorbitol group (25 g daily ) for 8 weeks consequently.
Score of depression will determine and analyzed in initial time of study and eight weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110262545N2
Registration date:2012-04-18, 1391/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Naimeh Akbaritorkestani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3500
Email address
n.akbary@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Arak University of Medical Sciences.
Expected recruitment start date
2009-09-16, 1388/06/25
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation of the effect of Fenugreek seed - flax seed and soy on the severity of depression at menopause
Public title
Comparative investigation of the effect of Fenugreek seed - flax seed and soy on the severity of depression at menopause
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: amenorrhea during the previous 12 months; with reporting menopausal depression; normal blood pressure; without use of estrogen and progesterone; without use anti depressant and anti anxiety drugs during the previous 6 months; without use of anticoagulants and NSAIDs for example ibuprofen; with out history of asthma and allergy.
Exclusion criteria:Incorrect use of herbal plants; home change; skin irritation .
Age
From 45 years old to 55 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht, Arak, Iran.
City
Arak
Postal code
3848176941
Approval date
2009-09-16, 1388/06/25
Ethics committee reference number
88-65-8
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression score
Timepoint
before intervention and two months after
Method of measurement
Beck depression questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Participants in first group by 6 grams of Fenugreek daily for 8 consecutive weeks, every day will be taken orally
Category
Treatment - Drugs
2
Description
Participants in second group by 25 grams of flaxseed daily for 8 consecutive weeks, every day will be taken orally
Category
Treatment - Drugs
3
Description
Participants in third groups by 25 grams of Soy daily for 8 consecutive weeks, every day will be taken orally
Category
Treatment - Drugs
4
Description
Participants in Control group by 25 grams of Sorbitol daily for 8 consecutive weeks, every day will be taken orally .