The Effect of Vitex Agnus Castus Extract on Blood Level of Prolactin & It,s Hormonal, Metabolic & Histological Effects in Comparison with Bromocriptin & Dostinex in Hyperprolactinemic Women
Evaluate the effect of Vitex agnus castus extract on blood level of prolactin & its Hormonal, Metabolic & histological effects in comparison with Bromocriptin & Dostinex in hyperprolactinemic women
Design
Non randomized, 3 arm parallel groups trial by physician. assessment by blind person, sample size 105, phase 2-3
Settings and conduct
Among women with hyperprolactinemia referring to treatment centers, about 105 persons selected and divided into three 35 persons groups: bromocriptine, dostinex and vitagnus for the 4 menstrual cycle، assessment personnel blinded.
Participants/Inclusion and exclusion criteria
Enter:
women with hyperprolactinemia
Age 18-45
Confirm letter of satisfaction
Not enter:
Pregnancy
Intervention groups
1.bromocriptine receiving group
2. dostinex receiving group
3. vitagnus receiving group
Main outcome variables
level of blood prolactin؛ level of blood total cholesterol؛ level of blood LDL؛ level of blood HDL؛ level of blood triglyceride؛ thickness of endometrium؛histological defference of endometrium؛ level of blood FSH day 9-12؛ level of blood estradiol day 9-12؛ level of blood LH day 12-14؛ level of blood midluteal progestrone day 14-17.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046171N1
Registration date:2020-02-03, 1398/11/14
Registration timing:retrospective
Last update:2020-02-03, 1398/11/14
Update count:0
Registration date
2020-02-03, 1398/11/14
Registrant information
Name
Naiyereh Haerifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3196 6522
Email address
naiyereh.haerifar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2018-10-22, 1397/07/30
Scientific title
The Effect of Vitex Agnus Castus Extract on Blood Level of Prolactin & It,s Hormonal, Metabolic & Histological Effects in Comparison with Bromocriptin & Dostinex in Hyperprolactinemic Women
Public title
The Effect of Vitex Agnus Castus Extract on Blood Level of Prolactin & It,s Hormonal, Metabolic & Histological Effects in Comparison with Bromocriptin & Dostinex in Hyperprolactinemic Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with hyperprolactinemia
Age 18-45
confirm letter of satisfaction
Exclusion criteria:
Pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
105
Actual sample size reached:
103
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Personnel of laboratory, radiology & clinical care,was blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical science faculty,Tabriz Branch, Islamic Azad University.
Street address
Islamic Azad university of Tabriz, Pasdaran Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.IAU.TABRIZ.REC.1395.1
Health conditions studied
1
Description of health condition studied
Hyperprolactinemia.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood level of prolactin
Timepoint
One week before treatment,One, Two, Three & Four menstrual cycle after starting treatment
Method of measurement
sampling of blood serum
Secondary outcomes
1
Description
Total Cholesterol
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
2
Description
LDL Cholesterol
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
3
Description
HDL Cholesterol
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
4
Description
triglyceride
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
5
Description
Follicle stimulating hormone (FSH)
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
6
Description
Luteinizing Hormone (LH)
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
7
Description
Estradiol
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles
Method of measurement
Vein Blood sampling
8
Description
Progesterone
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 17-22 days of menstrual cycles
Method of measurement
Vein Blood sampling
9
Description
Thickness of endometrium
Timepoint
Before Intervention and for 4 cycles with Intervention, Between 1-3 days of menstrual cycles