Evaluation of the effect of Nigella sativa extraction supplement for benign prostatic hyperplasia patients treatment: A randomized placebo-controlled clinical trial
Nigella sativa extraction supplement will be utilized for Benign prostatic hyperplasia patients treatment.
Design
Clinical trial with intervention and control groups, single-blinded, randomized, phase 3 on 50 patients. Random numbers technique will be used for randomization.
Settings and conduct
In this clinical trial study, 60 individuals with benign prostate hyperplasia that refer to Imam Reza Hospital of Tabriz, will be randomly divided into two groups of 30 individuals that the target and control groups will receive Nigella sativa extraction supplement and placebo, respectively. Type of blinding will be single-blinded and all names and personal information of the patients will be encoded at the beginning of study and it will completely remain confidential.
Participants/Inclusion and exclusion criteria
Including criteria: Having benign prostate hyperplasia with or without lower urinary tract symptoms, eligible to participate in the study
Excluding criteria: Presence of possible allergy to Nigella sativa extraction supplement
Intervention groups
Intervention group is including of benign prostate hyperplasia that receive Nigella sativa extraction supplement intervention.
Comparison group is including of benign prostate hyperplasia that receive placebo intervention.
Main outcome variables
Evaluation of urinary problems, measuring the prostatic volume, measuring the remained urine volume, evaluating prostatic specific antigen (PSA) level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049311N4
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Seyyedeh Mina Hejazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
smhjz.biotech@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Nigella sativa extraction supplement for benign prostatic hyperplasia patients treatment: A randomized placebo-controlled clinical trial
Public title
Effect of Nigella sativa extraction supplement in benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having benign prostate hyperplasia with or without lower urinary tract symptoms
Eligible to participate in the study
Exclusion criteria:
Presence of possible allergy to Nigella sativa extraction supplement
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be perform by simple randomization. patients will be numbered based the referred date and on the other hand, 60 numbers will be written from 1 to 60 and then 30 numbers will be randomly selected among them that will be Nigella sativa extraction supplement receiving. Other patients number will receive placebo.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study will be perform as single-blinded and only patients will be blinded. Nigella sativa extraction supplement and placebo will be placed in similar and coded cans and volunteers will not be informed about receiving the brand drug or the other drugs. Furthermore, the placebo will be similar with the drug in terms of appearance (shape and color), the taste and smell. Therefore, patients will be unaware from prescribed drugs and assignment of utilized drug in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-07-26, 1400/05/04
Ethics committee reference number
IR.TBZMED.REC.1400.377
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Evaluation of urinary problems
Timepoint
At first, 2, 4 and 8 weeks after the drug intervention
Method of measurement
Designed IPSS questionnaire
2
Description
Measuring the prostatic volume
Timepoint
At first, 2, 4 and 8 weeks after the drug intervention
Method of measurement
Evaluation of ultrasound results
Secondary outcomes
1
Description
Measuring the remained urine volume
Timepoint
At first, 2, 4 and 8 weeks after the drug intervention
Method of measurement
Evaluation of ultrasound results
2
Description
Evaluating prostatic specific antigen (PSA) level
Timepoint
At first, 2, 4 and 8 weeks after the drug intervention
Method of measurement
ELISA test from blood samples
Intervention groups
1
Description
Intervention group: capsule recipients containing 75 milligram hydroalcoholic Nigella sativa extraction of Zahravi pharmatheutical company in the form of two capsules per meal (three times a day) which will be taken orally.
Category
Treatment - Drugs
2
Description
Control group: placebo capsule recipients containing excipient in the form of two capsules per meal (three times a day) which will be taken orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Tabriz
Full name of responsible person
Dr. Mohammadreza Ardalan
Street address
Imam Reza hospital, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3992
Email
Ardalan34@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Tabriz university of medical sciences, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Kidney research center, Tabriz university of Medical Sciences, Golgasht St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51566614756
Phone
+98 41 3337 3992
Email
ardalan34@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kidney research center, Tabriz university of Medical Sciences, Golgasht St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51566614756
Phone
+98 41 3337 3992
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kidney research center, Tabriz university of Medical Sciences, Golgasht St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51566614756
Phone
+98 41 3337 3992
Email
ardalan34@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD