Protocol summary

Summary
Nigella sativa (N. sativa) seed is a commonly used herb which has been shown to possess in vitro antihelicobacter activity. The objective of the study is to evaluate the efficacy of N. sativa seeds in eradication of H. pylori infection in non-ulcer dyspeptic (NUD) patients. The study will be conducted on 110 adult patients, both sexes with the age range of 18-65 years, attending the Gastroenterology Division of the Department of Medicine, King Fahd Hospital of the University, AlKhobar, Saudi Arabia from March 2007 to August 2008. Patients complaining of dyspeptic symptoms and found positive for H. pylori infection as confirmed by histopathology and urease test will be included in the study. Those suffering from peptic ulcer, gastric cancer or other gastrointestinal bleeding as seen during endoscopy; or who have taking proton-pump inhibitors, bismuth or antibiotics in the last 4 weeks before endoscopy; or pregnant or lactating, or intolerant to therapeutic regimens will be excluded from the study. Approval from ethics committee and written consent from patients will be obtained. Patients will be randomly assigned to four groups, receiving: Triple therapy (clarithromycin, amoxicillin and omeprazole), 1g N. sativa and 40mg omeprazole, 2g N. sativa and 40mg omeprazole, or 3g N. sativa and 40mg omeprazole. Negative H. pylori stool antigen, 4 weeks after end of treatments will be considered as eradication. We hope that N.sativa will be a useful cheap and easily available alternate/adjunct treatment for the eradication of H.pylori.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138802061848N1
Registration date: 2009-07-11, 1388/04/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-07-11, 1388/04/20
Registrant information
Name
Muhammad Akram Randhawa
Name of organization / entity
King Faisal University
Country
Saudi Arabia
Phone
00966-3-8577000/2146
Email address
mrandaua@kfu.edu.sa
Recruitment status
Recruitment complete
Funding source
King Faisal University, Dammam, Saudi Arabia
Expected recruitment start date
2007-03-15, 1385/12/24
Expected recruitment end date
2008-08-14, 1387/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Nigella sativa and triple therapy in eradication of Helicobacter pylori in patients with non-ulcer dyspepsia
Public title
Study for effectiveness of Nigella sativa (Black seed) in patients with dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Patients complaining of dyspeptic symptoms 2) Patients with positive result for H. pylori infection confirmed by both histopathology and rapid urease test (CLO test) Exclusion criteria: 1) the endoscopy showed peptic ulcer, gastric cancer or other gastrointestinal bleeding 2) they had taken proton-pump inhibitors, bismuth or antibiotics in the last 4 weeks before endoscopy 3) pregnant or lactating 4) intolerant to therapeutic regimens
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee King Faisal University
Street address
King Faisal University
City
Dammam
Postal code
31451
Approval date
2009-06-13, 1388/03/23
Ethics committee reference number
KFU-LEC-129

Health conditions studied

1

Description of health condition studied
Non-ulcer dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia

Primary outcomes

1

Description
Eradication of H. pylori
Timepoint
4 weeks after the end of treatment
Method of measurement
Negative stool antigen by rapid monoclonal immunochromatographic method (ImmunoCard STAT! HpSA, Meridian Bioscience Europe)

Secondary outcomes

1

Description
Improvment in dyspeptic symptoms (epigastric pain and reflux symptoms)
Timepoint
4 weeks after end of teatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Triple therapy (clarithromycin+amoxicillin+omeprazole)
Category
Treatment - Drugs

2

Description
1g of Nigella sativa seeds powder in capsule + 40mg omeprazole
Category
Treatment - Drugs

3

Description
2g of Nigella sativa seeds powder in capsule + 40mg omeprazole
Category
Treatment - Drugs

4

Description
3g of Nigella sativa seeds powder in capsule + 40mg omeprazole
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
King Fahd Hospital of the University, Gastroenterology Division,
Full name of responsible person
Prof Abdelaziz Al-Quorain
Street address
Gastroenterology Division, King Fahd Hospital of hte University
City
Al-Khobar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
King Faisal University
Full name of responsible person
Abdulaziz Abdulmohsin Almulhim
Street address
Dean Scientific Research and Higher Education, King Faisal University
City
Al-Ahsa
Grant name
Grant code / Reference number
KFU:8051
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
King Faisal University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
King Faisal University
Full name of responsible person
Dr Muhammad Akram Randhawa
Position
MBBS, PhD, Associate Professor
Other areas of specialty/work
Street address
Department of Pharmacology, College of Medicine, PO Box 2114
City
Dammam
Province
Eastern Province
Postal code
31451
Phone
00966-3-8577000 ext 2146
Fax
Email
mrandaua@kfu.edu.sa
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
King Faisal University
Full name of responsible person
Dr Muhammad Akram Randhawa
Position
MBBS, PhD, Associate Professor
Other areas of specialty/work
Street address
Department of Pharmacology, College of Medicine, PO Box 2114
City
Dammam
Province
Postal code
31451
Phone
00966-3-8577000 ext 2146
Fax
Email
mrandaua@kfu.edu.sa
Web page address

Person responsible for updating data

Contact
Name of organization / entity
King Faisal University
Full name of responsible person
Dr. Talay Yar
Position
MBBS, PhD Assistant Professor
Other areas of specialty/work
Street address
Department of Physiology, College of Medicine, PO Box 2114
City
Dammam
Province
Postal code
31451
Phone
00966-3-8577000 ext 2327
Fax
Email
tyar@kfu.edu.sa
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...