Study on efficacy of honey based formulation of Nigella sativa seed oil in treatment of functional dyspepsia: A double blind randomized controlled clinical trial
This study aimed to evaluate the efficacy of Nigella sativa seed oil mixed with honey in treatment of patients with functional dyspepsia. Seventy patients diagnosed as functional dyspepsia according to ROME III criteria and confirmed by upper gastrointestinal endoscopy were selected and randomly divided in to two equal groups. Patients with organic causes of dyspepsia, peptic ulcer disease, inflammatory bowel disease or pure gastroesophageal reflux disease were excluded from the study. Patients in both groups were instructed to take 5 ml of Nigella sativa seed oil mixed with honey or placebo, 3 times per day after their meal. Patients in both groups also received 40 mg famotidine drug daily during the study.The dyspepsia severity as a primary out come and presence of H. pylori infection and different domains of health survey as secondary outcome were determined in both groups prior to and following 8 weeks of the intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201505031157N11
Registration date:2015-06-03, 1394/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Institute of Medicinal Plants
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on efficacy of honey based formulation of Nigella sativa seed oil in treatment of functional dyspepsia: A double blind randomized controlled clinical trial
Public title
Efficacy of Nigella sativa seed oil in treatment of functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with clinical diagnosis of functional dyspepsia. Exclusion criteria: Patients with organic causes of dyspepsia; peptic ulcer disease; inflammatory bowel disease; pure gastroesophageal reflux disease; incomplete or discontinuation of treatment functional dyspepsia; patients with a history of taking H. pylori eradicating medication in previous 3 months; any gastrointestinal surgery; clinical history of any underlying disease such as coronary heart disease, diabetes mellitus, asthma, cancer, and chronic obstructive pulmonary disease; taking medication such as antihypertensive drugs, corticosteroids and supplements such as iron and calcium.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Tebo-o-Din Center, Vanak squer, Molasadra Ave
City
Tehran
Postal code
1484958693
Approval date
2010-12-12, 1389/09/21
Ethics committee reference number
22-340/s
Health conditions studied
1
Description of health condition studied
Diseases of the digestive system
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
Functional dyspepsia
Timepoint
At starting of the study and after 8 weeks
Method of measurement
Functional dyspepsia was measured according to ROME III criteria and confirmed by upper gastrointestinal endoscopy
Secondary outcomes
1
Description
Helicobacter pylori infection
Timepoint
At starting of the study and after 8 weeks
Method of measurement
Helicobacter pyloril infection was determined in laboratory by commercial urease test kit
2
Description
Health survey
Timepoint
At starting of the study and after 8 weeks
Method of measurement
Health survey was determined according to standared health survey short form (SF-36)
Intervention groups
1
Description
Intervention group: 5 ml herbal drug (Mixture of Nigella sativa oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week
Category
Treatment - Drugs
2
Description
Placebo group: 5 ml placebo (Mixture of mineral oil, honey and water in equaled proportion) administered 3 times a day orally for 8 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroentrology and Liver diseases research center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Mohtashami
Street address
Vanak squer, Molasadra Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Institute of Medicinal Plants
Full name of responsible person
Reza Hajiaghaee
Street address
Tehran-Qazwain Highway Research City Kavosh, Jahad daneshgahi research society
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Institute of Medicinal Plants
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
Institute of Medicinal Plants
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D. in Pharmacology
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55th km of Tehran-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 263476401020
Fax
+98 34764021
Email
huseini_fallah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastroentrology and liver diseases research center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Mohtashami Reza
Position
MD Internists
Other areas of specialty/work
Street address
Vanak Squer, Molasadra Ave
City
Tehran
Postal code
1484958693
Phone
+98 26 8806 8923
Fax
+98 88068923
Email
Reza_mohtashami1979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Institute of Medicinal Plants
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D. in Pharmacology
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55th km of Tehran-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 263476401020
Fax
+98 34764021
Email
huseini_fallah@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)