Evaluation of the synergistic effect of curcumin in controlling urinary irritation symptoms after endoscopic benign prostatic hyperplasia in comparison with anticholinergic treatment alone
Evaluation of the synergistic effect of curcumin on the control of urinary irritation symptoms after endoscopic benign prostatic hyperplasia in comparison with anticholinergic treatment alone
Design
RCT with control group, with parallel groups, single blind, randomized, on 80 patients. randomization methode is by using Envelopes.
Settings and conduct
This study will be performed in the urology department of Imam Reza Hospital. Patients with benign prostatic hyperplasia who have undergone endoscopic surgery (TURP) and now have urinary irritation symptoms are being studied. We have two groups of intervention by random allocation method. The first group was treated with anticholinergics and curcumin and the second group was treated with anticholinergics.
They are placed alone. One month later, the results of the improvement of stimulus symptoms are evaluated using a questionnaire (IPSS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with post-operative excitatory symptoms TURP.
Exclusion criteria: patients with severe preoperative irritation symptoms; existence of fever and symptoms of prostatitis; existence of bladder injury during surgery; active UTI.
Intervention groups
Intervention group: administration of anticholinergic drugs, one tablet twice a day with curcumin, one tablet once a day for one month in patients with benign prostatic hyperplasia who have undergone endoscopic surgery.
Control group: administration of anticholinergic drugs one tablet twice a day for a month in patients with benign prostatic hyperplasia who have undergone endoscopic surgery.
Main outcome variables
Score obtained based on the patient's irritating symptoms questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N9
Registration date:2021-11-03, 1400/08/12
Registration timing:retrospective
Last update:2021-11-03, 1400/08/12
Update count:0
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
2020-11-21, 1399/09/01
Actual recruitment end date
2021-05-05, 1400/02/15
Trial completion date
2021-06-10, 1400/03/20
Scientific title
Evaluation of the synergistic effect of curcumin in controlling urinary irritation symptoms after endoscopic benign prostatic hyperplasia in comparison with anticholinergic treatment alone
Public title
Evaluation of the synergistic effect of curcumin in controlling urinary irritation symptoms after endoscopic benign prostatic hyperplasia in comparison with anticholinergic treatment alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with benign prostatic hyperplasia who have undergone endoscopic surgery and now have symptoms of urinary irritation.
Exclusion criteria:
Patients with severe preoperative irritation symptoms
Existence of fever and symptoms of prostatitis
Existence of bladder injury during surgery
Existence of active urinary tract infection
Having underlying diseases such as high blood pressure
Glaucoma
Age
From 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization; after each patient with the inclusion criteria is referred, an envelope is taken in order and according to the code written in it (for example, group A / group B), the patient enters each of the mentioned groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
One side is blind.
Patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad Ethics Committee of the Medical School
Street address
Department of Knowledge & Health, Shahid Fakouri blvd, Mashhad, Khorasan Razavi Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2021-01-20, 1399/11/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.630
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.1
ICD-10 code description
hyperplasia of prostate (adenomatous)
Primary outcomes
1
Description
Score obtained based on the patient's irritating symptoms questionnaire
Timepoint
Before the intervention and one month after taking curcumin
Method of measurement
International Prostate Symptom Score (IPSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They are treated with anticholinergics at a dose of one tablet twice a day and oral curcumin tablets once a day. After one month from the start of treatment, the results of improving irritative symptoms using the Persian version of the questionnaire (IPSS) again. Will be evaluated.
Category
Treatment - Drugs
2
Description
Control group: Patients are treated with anticholinergics and with the same prescription as the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Salman Soltani
Street address
Margin of Imam Reza Square, Ibn Sina Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Taffaghodi
Street address
Khorasan Razavi, Mashhad, University Street, in front of University 18, Building No. 1 of Mashhad University of Medical Sciences (Ghorashi),
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodiM@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Department of Urology, on the edge of Imam Reza Square, Ibne Sina Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza hospital, on the edge of Imam Reza Square, Ibn Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Department of Urology, Imam Reza hospital, Ibn Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
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