The aim of this study isto compare the effect of black cohosh (simifugol ) and vitex agnus castus(agnugol) on menopausal symptoms in menopause women referring to Rafsanjan health care centers in 2016.
. Research population includes menopausal women between 45 to 65 years old who acquire at least 5 score of Menopause Rating Scale (MRS)questionnaire and have other inclusion criteria such as Stopping menstruation for 12 months or more and at least two times flashing in day. they are excluded If missing the drug more than two days and development of drug complication. Sample size is estimated 45 in each group according to previous studies and statistical formula. Sampling method is conveniencs, but samples are randomly assigned to three groups of receiving black cohosh, Agnugol and control using stratification method base on Questionnaire scores . Women in intervention groups are asked to consume one coated pills of black or Agnugol every night before going to bed for 8 weeks. Study instruments include a questionnaire for demographic variables and MRS questionnaire. Data were collected before starting intervention and the end of first and second months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030826971N1
Registration date:2016-06-11, 1395/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Rafsanjan University Medical Sceince
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigate the effect of black cohosh (simifugol ) and vitexagnus _castus(agnugol) on menopausal symptoms
Public title
compare the effect of balack kohosh and vitexagnus on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion measures: Getting 5 score from MRS questionnaire; Stopping menstruation for 12 months or more than; Age between 45 to 65 years old; No history of breast and uterus cancers and abnormal vaginal bleeding, No history of depression and liver, kidney or thyroid diseases; Inform concent for participate in the study.
Exclusion measures: Emerging side effects of drugs during the study; Forgetting to consume drugs more than two consecutive days in a week; Consuming other drugs such as progestin, anti-fertility pills and GNRH agonists and antagonists; Death of loved persons; Participate in new exercise program.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
using block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University Medical Science
Street address
Imam Ali street- cenral department of Rafsanjan University Medical Science
City
Rafsanjan
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.IR.RUMS.REC.1394.183
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- end of first month- end of second month
Method of measurement
MRS questionnaire
Secondary outcomes
1
Description
Possible Complications
Timepoint
Along with complications
Method of measurement
Inform the patient
Intervention groups
1
Description
intervantion group1:one Wired coated Simifugol tablet daily containing 6.5 mg of dried root Vogel Manufacturing Goldaru plant black kohesh drug for 8 weeks every night in the hour before bedtime preferably with some water
intervantion group2: one Enteric-coated Agnogol tablet daily containing 4.8 mg dried fruit extract herb Vitex (vitex-agnus castus) Manufacturing Goldaru plant, in a period of 8 weeks, every night before bed
Category
Treatment - Drugs
2
Description
control group: No drugs and just will fill the questionnaire at certain times
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health therputic center 7
Full name of responsible person
Fatemeh Fatholahi
Street address
Bvd Imam Reza
City
Rafsanjan
2
Recruitment center
Name of recruitment center
Health therputic center3
Full name of responsible person
Esmat Heidari
Street address
Shareati street
City
Rafsanjan
3
Recruitment center
Name of recruitment center
Health therputic center 4
Full name of responsible person
Shaabani Farzaneh
Street address
Amirkabir Street
City
Rafsanjan
4
Recruitment center
Name of recruitment center
Health therputic centerr 1
Full name of responsible person
Zohreh Samareh
Street address
Imam street
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Rafsanjan University Medical Science
Full name of responsible person
Dr Hamid Hakimi
Street address
Imam Ali street- The head office of the University of Medical Sciences-Research and Education Deputy
City
Rafsanjan
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 Rafsanjan University Medical Science
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
Name of organization / entity
Rafsanjan University Medical Science
Full name of responsible person
marzeyeh loripoor
Position
phd of reproductive health- assistant professor
Other areas of specialty/work
Street address
faculty of Rafsanjan Nursing and Midwifery
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m.loripoor@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University Medical Science
Full name of responsible person
marzeyeh loripoor
Position
phd
Other areas of specialty/work
Street address
faculty of Rafsanjan Nursing and Midwifery
City
Rafsanjan
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m.loripoor@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)