The effect of adding nigella sativa powder in addition to conventional medical treatment of helicobacter pylori on plasma ghrelin and appetite in patients with this infection
The aim of this study is evaluating the effect of adding nigella sativa powder in addition to conventional medical treatment of helicobacter pylori on plasma ghrelin and appetite in patients with this infection.
Design
Double blind randomized parallel clinical trial with two groups of control and intervention with a sample size of 60
Settings and conduct
Helicobacter pylori positive patients are selected among those who have referred to Motahhari clinic based on inclusion and exclusion criteria. Then informed consent and other questionnaires for participants are completed. Ultimately, patients are randomly assigned to one of the intervention or control groups.Patients are not aware of the two groups being studied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive result of helicobacter pylori infection
Exclusion criteria :
1. Body mass index greater than 30
2. Having an inflammatory or chronic diseases (kidney disease, liver disease, inflammatory bowel disease, heart ischemia, diabetes, lung disease, asthma, cancer, HIV, systemic inflammation and…)
3. Having history of gastric cancer or gastric surgery
4. Active GI bleeding and intense gastritis
5. Taking any antibiotics or bismuth from 6 weeks before the study
6. Taking all types of medication for helicobacter pylori before the study
7. Pregnancy or lactation at the same time as studying
8. Drinking alcohol or using narcotic at the same time as studying
Intervention groups
Control group : 4 capsules containing pharmaceutical starch daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori
Intervention group : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori
Main outcome variables
Alteration ghrelin hormone and alteration appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170916036204N7
Registration date:2018-08-08, 1397/05/17
Registration timing:registered_while_recruiting
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Najmeh Hejazi
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1005
Email address
nhejazi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences (SUMS)
Expected recruitment start date
2017-09-28, 1396/07/06
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding nigella sativa powder in addition to conventional medical treatment of helicobacter pylori on plasma ghrelin and appetite in patients with this infection
Public title
The effect of nigella sativa powder on appetite and appetite hormone in patients with helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive result of helicobacter pylori infection
Exclusion criteria:
Body mass index greater than 30
Having an inflammatory or chronic diseases (kidney disease, liver disease, inflammatory bowel disease, heart ischemia, diabetes, lung disease, asthma, cancer, HIV, systemic inflammation and…)
Having history of gastric cancer or gastric surgery
Active GI bleeding and intense gastritis
Taking any antibiotics or bismuth from 6 weeks before the study
Taking all types of medication for helicobacter pylori before the study
Pregnancy or lactation at the same time as studying
Drinking alcohol or using narcotic at the same time as studying
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with fixed block size of two.
Blinding (investigator's opinion)
Double blinded
Blinding description
The capsules presented to the control group are filled with colored pharmaceutical starch, with the same appearance and packaging as those given to intervention group. So the patients do not recognize which of the two groups they are in. Also, the physician and the data analyst are unaware of this.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Iran, Fars,Shiraz,Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-08-30, 1396/06/08
Ethics committee reference number
Ir.Sums.Rec.1396.98
Health conditions studied
1
Description of health condition studied
helicobacter pylori infection
ICD-10 code
k31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
ghrelin hormone
Timepoint
at the beginning and the end of the study (after 8 weeks )
Method of measurement
ghrelin kit
Secondary outcomes
1
Description
appetite
Timepoint
at the beginning and the end of the study
Method of measurement
appetite questionnaire
Intervention groups
1
Description
control group : 4 capsules containing pharmaceutical starch daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori
Category
Placebo
2
Description
intervention group : 4 capsules of 500 mg containing nigella sativa powder daily for 8 weeks in addition to conventional medical treatment of helicobacter pylori
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Mahvash Alizadeh
Street address
Motahari Clinic, Namazi square, Shiraz
City
Shiraz
Province
Fars
Postal code
7166776770
Phone
+98 71 3612 1000
Email
Nhejazi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences-Vice Chancellor for Research Affairs Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Hedie Yousefnejad
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Fax
Email
H.YNEJAD@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Najme Hejazi
Position
PHD in Nutrition Sciences, Assistant Professor of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Fax
Email
Nhejazi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Hedie Yousefnejad
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Fax
Email
H.ynejad@yahoo.com
Web page address
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