The aim of this study is to compare the effect of marticaria chamomilla syrup versus cabergoline in idiopathic hyperprolactinemia.
This study is a randomized controlled trial. We include idiopathic hyperprolactinemia women between 18 to 45 years old whose disease has recently been diagnose and serum prolactin level is above25 μgr/L with asymptomatic or mild symptoms. Patient with liver failure, kidney failure, hypothyroidism, prolactinoma, pituitary and hypothalamus disease are not enrolled. Those patient who take any medication that is effective in prolactin secretion in the last three months and who has sensitivity to ergot derivatives are not entered in the study. A total of 158 patient are divided into two 79 member groups. One group is treated with syrup of marticaria chamomillaand the other with the cabergoline tablet for one month. At the beginig of the experiment and 30 days after the usage of drug serum prolactin level are measured and the results are compared across the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122215891N1
Registration date:2014-06-20, 1393/03/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-20, 1393/03/30
Registrant information
Name
Marya Kabiri
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 2188
Email address
m-kabiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
From Traditional Medicine Faculty, Tehran University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of marticaria chamomilla syrup and cabergoline on hyperprolactinemia
Public title
hyperprolactinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient satisfaction; Female; Outpatients older than 18 years; Patient with asymptomatic or mild symptoms idiopathic hyperprolactinemia (menstrual disorders that are just starting with or without galactorrhea or without bothering galactorrhea alone); Serum prolactin level above 25 μgr/L
Exclusion criteria: Patients older than 45 years; Patient with liver failure; Patient with kidney failure; Patient with hypothyroidism; Taking medication such as haloperidol, phenothiazine, butyrophenone, monoamine oxidase inhibitor, fluoxetine, sulpiride, metoclopramide, domperidone, tricyclic antidepressants, opioid, estrogen, verapamil, reserpine, methyldopa, benzodiazepine, cimetidine, medroxolol drugs and any medication that is effective in prolactin secretion in the last three months; The use of warfarin; The use of sedating; Prolactinoma( micro or macro adenoma); Adrenal, pituitary and hypothalamus disease; Pregnant women; Women who plan to become pregnant; Breast feeding; Autoimmune disease such as lupus; Long- term menstural disorders; Bothering galactorrhea; Underlying disease such as diabetes, hypertension and cancer; History of hyperprolactinemia treatment in the last 6 months; The use of propranolol and vasoconstrictor drugs; Raynaud’s disease; History sensitivity to ergot derivatives; History of stomach ulcers and gastrointestinal bleeding; Asthma; History of hay fever and allergic reaction to member of the compositae family such as yarrow, feverfew, artemisia, tansy
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
158
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Traditional Medicine, Tehran University of Medical Sciences
Street address
Keshavarz Blv Ghods St Tehran
City
Tehran
Postal code
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
130/45/د/93
Health conditions studied
1
Description of health condition studied
Hyperprolactinaemia
ICD-10 code
E 22.1
ICD-10 code description
Hyperprolactinaemia
Primary outcomes
1
Description
Serum prolactin level
Timepoint
Before and after the intervention
Method of measurement
Laboratory measurement
Secondary outcomes
1
Description
Side effects
Timepoint
During the treatment
Method of measurement
questionnaire and Physical exam
Intervention groups
1
Description
Medication administration ( marticaria chamomilla syrup) 5 cc two times a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Cabergoline 0.25 mg twice a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Marya Kabiri
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Dr. Minaei
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
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
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Marya Kabiri
Position
Physician, PhD student
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
009821:55601274
Fax
Email
m-kabiri@razi.tums.ac.ir, marya_kabiri@yahoo.om
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farnaz Sohrabvand
Position
Associated professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Keshavar Boulevard
City
Tehran
Postal code
Phone
+98 21 6119 2741
Fax
Email
fsohrabvand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Marya Kabiri
Position
Physician, PhD student
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
m-kabiri@razi.tums.ac.ir, marya_kabiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)