Investigating the effect of curcumin tablets on pain, blood pressure and blood coagulation in patients undergoing surgery for benign prostatic hyperplasia through urethral incision
Investigating the effect of curcumin tablets on pain, blood pressure and blood coagulation in patients with benign prostatic hyperplasia undergoing urethral resection surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 4 on 184 patients. Randomized block method was used for randomization.
Settings and conduct
This study will be conducted in Golpayegani Hospital, Qom. This study is double blind. The patients and the person who collects the patients' information do not know which group the patient belongs to. In the control group, 25 mg pethidine ampoule every 8 hours and a placebo pill will be prescribed daily. In the intervention group, in addition to 25 mg pethidine ampoule every 8 hours, a 47.5 mg curcumin tablet will be prescribed daily.
Participants/Inclusion and exclusion criteria
Patients who have undergone prostate urethral resection surgery; Not having coagulation disorders; and Not having an allergy to curcumin Not having drug addiction.
Intervention groups
In the control group, 25 mg pethidine ampoule every 8 hours and a placebo pill will be prescribed daily. In the intervention group, in addition to 25 mg pethidine ampoule every 8 hours, a 47.5 mg curcumin tablet will be prescribed daily.
Main outcome variables
Pain reduction, better control of blood pressure and improvement of blood coagulation of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231022059810N1
Registration date:2023-12-06, 1402/09/15
Registration timing:registered_while_recruiting
Last update:2023-12-06, 1402/09/15
Update count:0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Atye Babaii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1300
Email address
a.babaii@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin tablets on pain, blood pressure and blood coagulation in patients undergoing surgery for benign prostatic hyperplasia through urethral incision
Public title
Investigating the effect of curcumin tablets on pain, blood pressure and blood coagulation in patients undergoing surgery for benign prostatic hyperplasia through urethral incision
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone prostate urethral resection surgery
Not having coagulation disorders
Not having an allergy to curcumin
Not having drug addiction
Exclusion criteria:
Abnormal bleeding after surgery (more than 300 cc)
Criticality of the patient's vital signs
Age
From 18 years old
Gender
Male
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (250 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know whether they are using a placebo or the real drug. The person who collects the information also does not know whether the patient used a placebo or the real drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Qom University of Medical Science, Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.MUQ.REC.1402.154
Health conditions studied
1
Description of health condition studied
Hyperplasia of prostate
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Pain
Timepoint
Immediately before the intervention and every 6 hours after the intervention until discharge
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Immediately before the intervention and every 6 hours after the intervention until discharge
Method of measurement
Vital Sign Monitoring Device
2
Description
Blood coagulation tests
Timepoint
Immediately before the intervention and every 24 hours after the intervention until discharge
Method of measurement
Using PT, PTT, INR laboratory tests
Intervention groups
1
Description
In the control group, 25 mg Pethidine ampoule every 8 hours and a placebo pill will be prescribed daily.
Category
Placebo
2
Description
In the intervention group, in addition to 25 mg Pethidine ampoule every 8 hours, a 47.5 mg Curcumin tablet will be prescribed daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golpayegani Hospital
Full name of responsible person
Atye Babaiiَ
Street address
Golpayegani Hospital, Khakfarej Ave.
City
Qom
Province
Ghoum
Postal code
3719665786
Phone
+98 25 3616 1111
Email
h.golpayegani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Ali
Street address
Qom University of Medical Science, Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1100
Email
R.ali@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Atye Babaii
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Science, Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1100
Email
a.babaii1400@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Atye Babaii
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Science, Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1100
Email
a.babaii1400@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Atye Babaii
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Science, Saheli Ave.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1100
Email
a.babaii1400@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available