This study is a randomized triple-blind clinical trial of controlled groups in which the effect of garlic tablets compared with placebo on the pain of women with endometriosis has studied. The Research is carried out in Avicenna institute. The Research community is all 20-45 years old women with endometriosis who come for treatment in the institute in a 6 month period. The cases are chosen according to the criteria of inclusion and agreement of participant. Then they are divided randomly in intervention or control groups. Women who are in intervention group are swallowed 400 mg garlic tablets produced in Dinah pharmaceutical company, and the control group will receive placebo pills that contain the starch. Both tablets will be daily given to patients for 12 weeks; their pain is measured by VAS. The Pain of each patient will be measured before entering the study and then 2 times a week by VAS.Inclusion criteria: Endometriosis diagnosing by the doctor, Age 20-45 years, Painful endometriosis, using Standard treatments of Avicenna, no garlic allergy.
Exclusion criteria: emerging of any known physical or mental illness during the study, improperly consumption of garlic pills by patients.
General information
Acronym
Effects of garlic tablets compared to placebo on pain in women with endometriosis
IRCT registration information
IRCT registration number:IRCT201501059463N35
Registration date:2015-06-15, 1394/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences ،School of Nursing and Midwifery
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic tablet on the endometriosis related pain in women
Public title
The effect of garlic tablet on the endometriosis related pain in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Endometriosis diagnosing by the doctor, Age 20-45 years, Painful endometriosis, with out any other physical disorders and mental health problems known, using Standard treatments of Avicenna, using of NSAID group Analgesic ,No garlic allergy, No referring to infertility treatment.
Exclusion criteria: emerging of any known physical or mental illness during the study, improperly consumption of garlic pills by patients, The unwillingness of to continue the study.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, at the corner of the streets of Jerusalem, the headquarters building
City
Tehran
Postal code
1419733171
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
911373006
Health conditions studied
1
Description of health condition studied
Reduce pain in women with endometriosis
ICD-10 code
O94,O99
ICD-10 code description
Other Obstetric Conditions, Not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
Three months during the intervention.
Method of measurement
vas
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will take one garlic tablet (400 mg) manufactured by Dinah company per day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group will take one Starch tablet manufactured by Dinah company per day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Avicenna
Full name of responsible person
Dr zahra Behboodi Moghadam
Street address
Shariati Street, crossing glaciers, No. 97
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Yonesian
Street address
Keshavarz Boulevard Tehran University of Medical Sciences
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr zahra Behboodi Moghadam
Position
PhD in of reproductive health
Other areas of specialty/work
Street address
Unity School of Nursing and Midwifery I first victory Eastern
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 66904252
Email
Bahar_behboodi@yahoo.com
Web page address
WWW.FUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra behboodi moghadam
Position
PhD in of reproductive health
Other areas of specialty/work
Street address
Tehran, Tohid Square, St. N. North, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 66904252
Email
Bahar_behboodi@yahoo.com
Web page address
www.fums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soodabhe amirsalari
Position
MSc
Other areas of specialty/work
Street address
Tehran, Tohid Square, St. N. North, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
1419733171
Phone
+98 21 8892 7594
Fax
+98 66904252
Email
sudisalari@gmail.com
Web page address
www.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)