In the present double-blind clinical trial study, 80 men suffering from type 2 diabetes and sexual dysfunction who refer to the endocrinology clinic of Valiasr Hospital of Zanjan are recruited. For all patients sexual dysfunction standard questionnaires will be completed; personal demographics, anthropometric measurements, and drug history will be also taken. Then they are randomly assigned to four twenty-member groups including: sindenafil, bupropion, Ginseng, and placebo. For 10 weeks, patients of four groups are treated with oral medication including 50 mg of sindenafil tablet to the first group, 150 mg of bupropion (extended release) to the second group, Ginseng to the third group, and placebo to the forth group. After 10 weeks, for all the participants the questionnaires will be completed again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111819554N11
Registration date:2016-12-11, 1395/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-11, 1395/09/21
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the Efficacy of Bupropion tablets with sildenafil tablet and Ginseng in sexual function in men with type 2 diabetes with erectile dysfunction.
Public title
Effect of bupropion tablets compared to sildenafil tablets and Ginseng on sexual function (erectile dysfunction) in men with type 2 diabetes who were referred to endocrinology clinic of Vali Asr Hospital of Zanjan.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 30-80 years ild; sexual dysfunction from 6 month ago; no relationship problems with partner from 6 month ago; HbA1c less than 10 & FBS less than 200 from 6 month ago; normal serum testosterone and prolactine levels; non-interference in the our drugs with prescription medications; no history of priapism.
Exclusion criteria: the anatomical penile dysfunction; history of prostatectomy; sever hematologic & renal &liver dysfunction; Nitrate consumption; coronary artery disease; blood pressure more than 170/100 or less than 90, proliferative retinopathy; autonomic neuropathy; ketoacidosis history in 2 years ago; tachycardia.
Age
From 30 years old to 80 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhoori Eslami street, Azadi blv
City
Zanjan
Postal code
45156-13191
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
IR.ZUMS.REC.1394.01
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
N52.9
ICD-10 code description
Male erectile dysfunction, unspecified
Primary outcomes
1
Description
erectile dysfunctions
Timepoint
first day and 10 weeks later
Method of measurement
IIEF-5 standard questionnaire
2
Description
serum colestrol level
Timepoint
first day
Method of measurement
laboratory kits (Calorimetry enzimatic)
3
Description
serum triglyceride level
Timepoint
first day
Method of measurement
laboratory kits (Calorimetry enzimatic)
4
Description
serumfasting blood sugar level
Timepoint
first day
Method of measurement
laboratory kits (Calorimetry enzimatic)
5
Description
HbA1c
Timepoint
first day
Method of measurement
laboratory kits
6
Description
serum prolactin level
Timepoint
first day
Method of measurement
laboratory kits (elisa)
7
Description
serum Testosterone level
Timepoint
first day
Method of measurement
laboratory kits (elisa)
Secondary outcomes
empty
Intervention groups
1
Description
20 patients: Bupropion Tab(150mg)for 10 weeks
Category
Treatment - Drugs
2
Description
20 patients: Sildenafil Tab(50mg)for 10 weeks.
Category
Treatment - Drugs
3
Description
20 patients: Ginseng capsule for 10 weeks
Category
Treatment - Other
4
Description
20 patients: placebo for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic,Valiasr Hospital
Full name of responsible person
Dr. Ahmad Zolghadriha
Street address
Valiasr Hospital,Valiasr square
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Jomhoori Eslami street, Azadi blvd.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Maryam Jameshorani
Position
Internist
Other areas of specialty/work
Street address
Valiasr Hhospital, Valiasr square
City
Zanjan
Postal code
45157-77978
Phone
+98 24 3377 0814
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyed Abolfazl Gghoreishi
Position
Psychiatrist
Other areas of specialty/work
Street address
Beheshti Hospital, Ark square
City
Zanjan
Postal code
4513815788
Phone
+98 24 3354 4000
Fax
Email
sabgho@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Zolghadriha
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Beheshti Hospital, Ark square
City
Zanjan
Postal code
4513815778
Phone
+98 24 3354 4000
Fax
Email
ahmad_zolghadriha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)