Protocol summary

Study aim
To determine the effects of ginger consumption on eradication of H.pylori, clinical symptoms, inflammatory factors, and oxidative stress in patients with peptic ulcer
Design
A randomized, double-blinded, controlled clinical trial with a parallel group design of 42 patients. Random number table will be used for randomization.
Settings and conduct
42 eligible patients with peptic ulcer will randomly assign to consume four tablets daily each containing 500 mg of ginger or placebo for six weeks. Both groups will also receive the standard medical treatment in hospital. Patients’ blood samples will be taken before and after the intervention to determine inflamation factors and oxidative stress markers and the two groups will also be compared in eradication of H.pylori and clinical signs. In this study participants and investigators will be blinded and concealment will be done by a third person.
Participants/Inclusion and exclusion criteria
People with a diagnosis of peptic ulcer and in the age range of 18-80 who are able to intake tablets orally and desire to participate in the study will be included in the study. While people having pregnancy or breastfeeding, any history of allergy to ginger, antibiotic use in the last 4 weeks,active alcohol consumption or alcohol, corticosteroid and anticoagulant use,Cardiovascular, liver, lung, kidney diseases ,malignancy, recent surgery will be excluded from the study.
Intervention groups
1- intrvention groups: receiving 2g of ginger daily in the form of 500mg tablets for 6 weeks; 2-Plasebo group: placebo tablets for 6 weeks
Main outcome variables
Eradication of H.pylori; serum IL-8 level, serum TAC level; degree of heartburn and stomach pain; length of indigestion; score of dyspepsia questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004010N35
Registration date: 2023-02-08, 1401/11/19
Registration timing: registered_while_recruiting

Last update: 2023-02-08, 1401/11/19
Update count: 0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-08, 1401/11/19
Expected recruitment end date
2023-05-09, 1402/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of ginger consumption on eradication of H.pylori, clinical symptoms, inflammatory factors, and oxidative stress in patients with peptic ulcer
Public title
Evaluation of the effects of ginger consumption on eradication of H.pylori, clinical symptoms, inflammatory factors, and oxidative stress in patients with peptic ulcer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
General desire to practice the study Age over 18 years and less than 80 years Confirmation of H. pylori infection by stool antigen test or endoscopic pathology findings No antibiotic use in the last 4 weeks No active alcohol consumption or alcohol, corticosteroid and anticoagulant use No diseases Cardiovascular, liver, lung, kidney, malignancy Absence of recent surgery Absence of pregnancy or breastfeeding in women Absence of allergy to H pylori infection eradication regimen
Exclusion criteria:
Unwilling to continue the study Any allergic reaction to the supplements Consumption of less than 90% of supplements at the end of the study period
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into ginger group or placebo according to the table of random numbers at the beginning of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients won’t know if they are receiving the ginger or a placebo tablets and for double-blinding the study, the bottles containing the relevant tablets will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of tablets received by each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committie of the National Institute of Research and Food Industry
Street address
NO.7,West Arghavan Ave.,Farahzadi Blvd.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1401.057

Health conditions studied

1

Description of health condition studied
Peptic ulcer
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified

Primary outcomes

1

Description
H.Pylori eradication
Timepoint
8 week
Method of measurement
Endoscopy and Pathology

2

Description
Clinical Symptoms
Timepoint
8 week
Method of measurement
Questionnaire

3

Description
Anti-oxidant status
Timepoint
8 week
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: will take 2g of ginger daily in the form of four tablets each contains 500 mg of ginger (Product of Dine Company) orally for six weeks.
Category
Other

2

Description
Control group: will take four placebo tablets daily, which are similar in shape and taste to ginger tablet,orally for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani General Hospital
Full name of responsible person
Amir Sadeghi
Street address
Ayatollah Taleghani Educational Hospital,Araabi St.Yaman Ave,Chamran High Way,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghanihospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Street address
No.7,West Arghavan Ave.,Farahzad Blvd.,Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
a_hekmat2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.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
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
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