.The effectiveness of homeopathy(Ipecacuanha) in the treatment of bleeding and pain and improve the quality of life in patients with abnormal uterine bleeding
investigate the effect of homeopathy on Abnormal uterine bleeding
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized.
Settings and conduct
Interventions are a cure for homeopathic remedies with at least three doses for 3 months.
Patients refer from the baqiyatallah Clinic .
Participants/Inclusion and exclusion criteria
Participants in the study are women aged 25 to 50 with AUB complaints; Inclusion and exclusion criteria in this study include:
Inclusion Criteria: Having autoimmune diseases and cancer; lack of uterine polyps and fibromes above 3 cm; lack of severe bleeding that requires emergency treatment; have not used homeopathy so far.
Exclusion criteria: lack of follow-up; patients who use hormonal medications; patients who initially prescribed hormonal medications to the gynecologist.
Intervention groups
60 women with AUB complaints between 25 and 50 years of age who are divided into two groups of 30, will be selected. the first group receive the homeopathic drug and the other will be received a placebo.
Main outcome variables
The severity of bleeding and pain and quality of life (general health)
General information
Reason for update
Acronym
AUB : Abnormal uterine bleeding
IRCT registration information
IRCT registration number:IRCT20170118032033N3
Registration date:2018-03-05, 1396/12/14
Registration timing:retrospective
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Zohreh Naderi
Name of organization / entity
baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3531
Email address
rsr.z45naderi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah university of medical sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
.The effectiveness of homeopathy(Ipecacuanha) in the treatment of bleeding and pain and improve the quality of life in patients with abnormal uterine bleeding
Public title
.The effectiveness of homeopathy(Ipecacuanha) in the treatment in patients with abnormal uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with AUB complaint between 25 years to 50 years of age who receive mefenamic acid and tranexamic acid.
Lack of autoimmune diseases and cancer, uterine polyps and fibroids over 3 cm
lack of excessive bleeding that requires emergency action.
Exclusion criteria:
The lack of follow-up treatment.
Patients who already have used steroids and hormonal drug.
Patients who have been prescribed hormonal drugs initially gynecologist
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: The primary drug is numbered 1 and placebo is numbered 2, and the patient and the therapist do not know which drug is the primary and which placebo is.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
baqiyatallah university of medical sciences
Street address
Tehran-sheikh bahaee street-baqiyatallah university of medical sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-01-24, 1395/11/05
Ethics committee reference number
IR.Bmsu.REC.1395.220
Health conditions studied
1
Description of health condition studied
Abnormal uterine bleeding
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified
Primary outcomes
1
Description
pain
Timepoint
3 months follow up
Method of measurement
VAS questionnaire
2
Description
BLEEDING
Timepoint
3 months follow up
Method of measurement
PBAC questionnaire
3
Description
QUALITY OF LIFE
Timepoint
3 months follow up
Method of measurement
GHQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
ipecacuanha homeopathic medicine for at least three doses for 3 months will be administered
Category
Treatment - Drugs
2
Description
PLACEBO DRUG: The placebo same as the main medicine in shape, color and taste will be administered in same dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
BAQIYATALLAH UNIVERITY OF MEDICAL SCIENCES
Full name of responsible person
NADERI ZOHREH
Street address
VANAK SQUARE-SHEIKH BAHAEE STREET-BAQIYATALLAH UNIVERITY OF MEDICAL SCIENCES
City
TEHRAN
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3531
Email
z45naderi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
BAQIYATALLAH UNIVERSITY OF MEDICAL SCIENCES
Full name of responsible person
saberi-mohsen
Street address
BAQIYATALLAH UNIVERSITY OF MEDICAL SCIENCES
City
TEHRAN
Province
Tehran
Postal code
1435916471
Email
z45naderi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
BAQIYATALLAH UNIVERSITY OF MEDICAL SCIENCES
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Baqiyatallah university of medical sciences
Full name of responsible person
Zohreh Naderi
Position
general physician
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Baqiyatallah university of medical sciences-faculty of medicine
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3531
Fax
+98 21 8862 0869
Email
z45naderi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university
Full name of responsible person
Dr Ali Karimi
Position
general physician-homeopath
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Tehran university
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8820 5152
Fax
Email
Dralikarimi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah university of medical sciences
Full name of responsible person
Zohreh Naderi
Position
general physician
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Baqiyatallah university of medical sciences-faculty of medicine
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3531
Fax
+98 21 8862 0869
Email
z45naderi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available