Comparison between the effect of oral Pregabalin (75 mg) and Deuloxetin (30mg) with Amitryptilin) on decreasing chronic pelvic pain due to Endometriosis
The aim of the current study was a comparison between the effect of oral Pregabalin (75 mg) and oral Deuloxetin (30mg) (with Amitryptilin) on decreasing of chronic pelvic pain due to Endometriosis at Alzzahra Hospital throught 2014 and 2015. Inclusion Criteria were: Known case of Endometriosis (according to the pathologic or radiologic measures); Pelvic pain more than 6 months; Age between 18-60 years old; preception and signing of the consent inform. Exclusion Criteria: Previous surgeries; Need to strong opioids; co-existing pelvic disorders; History of urinary tract infection; Pregnancy and breast feeding; Epilepsy; Hypertension; Hypersensitivity to drugs; MAOI consumption; Closed angle Glocoma; Renal Disorders; Juindice or hepatic disorders; Alcohol consumption; Hyponatremia; Body weight >285 Pound. Studied population were 100 cases with pelvic pain and no response to the previous treatments. Pain scores will be measured with (numerical rating scale) NRS between two groups. Then assessed 2weeks, 1month and 3 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042916325N2
Registration date:2015-06-26, 1394/04/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-26, 1394/04/05
Registrant information
Name
Katayoun Haryalchi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
haryalchi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research-Guilan University of Medical Sciences
Expected recruitment start date
2016-03-21, 1395/01/02
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of oral Pregabalin (75 mg) and Deuloxetin (30mg) with Amitryptilin) on decreasing chronic pelvic pain due to Endometriosis
Public title
An assessment about the effect of Pregabaline(75 mg) or Deuloxetin(30 mg) on pain relief in CPD due to Endometriosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Known case of Endometriosis according to pathology or radiology; Pelvic pain more than 6 month; Age between 18 and 60 years old; Comprehension and sign the consent inform.
Exclusion Criteria: Previous surgery; Need to strong opioids; coexisting pelvic disorders; History of urinary tract infection,IBS, IBD, and cancer; Pregnancy and breast feeding; Psychiatric disorders(Minor and Major Depression, suicide, Bipolar disorders; Epilepsy; Hypertension; Hypersensitivity to drugs; MAOI consumption; Closed angle Glocoma; Renal Disorders; History of Juindice or hepatic disorders; Consumption of MAOI, SMRIs, SSRIs 2 weeks ago; Alcohol consumption; Hyponatremia; Weight gain>285 Pound
Age
From 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research-Guilan University of Medical Sciences
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences , Gaz squre
City
Rasht
Postal code
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
5930382802
Health conditions studied
1
Description of health condition studied
Inflammatory disease of uterus, except cervix
ICD-10 code
N71.1
ICD-10 code description
Chronic inflammatory disease of uterus
Primary outcomes
1
Description
Pain Score of Chronic pelvic pain due to Endometriosis
Timepoint
2 weeks, 1 month, and 3 months after receiving the first dose of drug
Method of measurement
Numerical Rating Scale(NRS)
Secondary outcomes
1
Description
Severity of Chronic pelvic pain due to Endometriosis
Timepoint
2 weeks, 1 month, and 3 months after receiving the first dose of drug
Method of measurement
With the question: How much do you experience pain relief after receiving treatment from our center? (0-100%)
Intervention groups
1
Description
Pregabalin 75 mg + Amitryptiline 10 mg
Category
Treatment - Drugs
2
Description
Duloxetin 30 mg + Amitryptiline 10 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzzahra Hospital
Full name of responsible person
Dr. Roya Faraji
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abtin Hydarzadeh
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences, Gaz Square
City
Rasht
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-Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Katayoun Haryalchi
Position
Assistant Professor of Anesthology
Other areas of specialty/work
Street address
Alzzahra Hospital, Namjoo Street
City
Rasht
Postal code
Phone
+98 133228724
Fax
Email
k_haryalchi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Katayoun Haryalchi
Position
Assistant Professr of Anesthology
Other areas of specialty/work
Street address
Alzzahra Hospital, Namjoo Street
City
Rasht
Postal code
Phone
+98 133228724
Fax
Email
k_haryalchi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.Sc. Midwifery
Other areas of specialty/work
Street address
Alzzahra Hospital, Namjoo Street
City
Rasht
Postal code
Phone
+98 13 3336 9224
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)