Objectives:The aim of this study is Comparative investigate the effect of vitexagnus _castus(agnugol) and Placebo on menopausal symptoms. Design:This study is a randomized clinical trial,double-blind ,placebo- control . Setting and conduct: the intervention period is 8-weeks.The demographic and Green questionnaires as well as .The samples are randomly divided into two separate groups. Similarly. Participants :The samples are 50 menopausal women aged 45 to 60 . The inclusion criteria consist of: age between 65-45 years; at least one year and a maximum of three years of their last menstrual period has passed; the number of hot flashes at least 2 times a day. Exclusion criteria consist of : smoking; at least for a period of 3 months are treated with hormones and antibiotics; systemic diseases such as kidney disease; blood pressure blood sugar; blood fat; depressed and anxious (anxiety and depression diagnosis based on diagnostic criteria DSM5 by psychiatrist); taking antithyroid drugs; gabapentin; SSRI; sulfonamides, methotrexate, Tryamtryn, sulfasalazine; the use of traditional medicines such as drug-induced flushing. Intervention: One group will receive capsules of vitexagnus _castus twice a day,next group of twice a day for 8 weeks . After 2 and 4 and 8 weeks participants will complete the questionnaires again . main outcome :The outcome of the The outcome of the study is improvement in menopausal symptoms.
General information
Acronym
Governmental
IRCT registration information
IRCT registration number:IRCT2016120528967N3
Registration date:2016-12-31, 1395/10/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-31, 1395/10/11
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-08, 1395/10/19
Expected recruitment end date
2017-09-04, 1396/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigate the effect of vitexagnus _castus(agnugol) and Placebo on menopausal symptoms: a double-blind randomized clinical trial
Public title
Compareing effects ofvitexagnus _castus(agnugol) and Placebo on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 65-45 years; at least one year and a maximum of three years of their last menstrual period has passed; the number of hot flashes at least 2 times a day. Exclusion criteria: smoking; at least for a period of 3 months are treated with hormones and antibiotics; systemic diseases such as kidney disease; blood pressure blood sugar; blood fat; depressed and anxious (anxiety and depression diagnosis based on diagnostic criteria DSM5 by psychiatrist); taking antithyroid drugs; gabapentin; SSRI; sulfonamides, methotrexate, Tryamtryn, sulfasalazine; the use of traditional medicines such as drug-induced flushing.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
kums.rec.1395.442
Health conditions studied
1
Description of health condition studied
menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
menopausal symptoms
Timepoint
before intervention- 2 weeks later- 4 weeks later- 8 weeks later
Method of measurement
Green Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First group will be given Tab agnugol oral, 2 times daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Second group will be Placebo Tab oral, 2 times daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent Clinics
Full name of responsible person
Ali Rahmani
Street address
Red Crescent clinics,Shahid Beheshti Blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
vfarnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical
Full name of responsible person
Safora Salemi
Position
Pychologist
Other areas of specialty/work
Street address
Faculty of Social Science, Opp to Ayatollah Taleghani Hospital, Shahid Beheshti Blvd,Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3821 1001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)