This study is designed to evaluate the efficacy of Pimpinella Anise product for patients with functional dyspepsia. Functional dyspepsia is characterized by a high prevalence rate and no standard conventional treatments which causes a significant reduction in the quality of life. Alternative therapies, such as herbal formulas, are widely used to treat FD. This randomized, double-blind, placebo-controlled trial will be performed at one University center and will include Pimpinella Anise product and placebo (corn) group. Each group will consist of 50 FD patients. four weeks of administration of Pimpinella Anise or placebo will be conducted. During the subsequent 2 months, follow-up observations of primary and secondary outcomes will be performed. The primary outcomes are differences as measured on the gastrointestinal symptoms scale and the secondary outcomes are differences as measured on the visual analogue scale for dyspepsia and on the questionnaire for FD-related quality of life. All outcomes will be measured at baseline, at 2, 4 weeks of treatment, and at the 2 month follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101214980N1
Registration date:2013-11-23, 1392/09/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Mohammad Mazaheri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2712
Email address
mohammad.mazaheri@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparable efficacy anise and corn starch in controlling symptoms in patients with Postprandial Distress Syndrome
Public title
Effect of Pimpinella Anise product in Postprandial Distress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients within 18-65 years old with Postprandial Distress Syndrome.
Exclusion Criteria: Using of chemical and herbal drugs؛ History of abdominal surgeries؛ History of bloody diarrhea؛ Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Isfahan University of Medical Sciences
Street address
Hezargrib Ave.
City
Isfahan
Postal code
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
292156
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Indigestion
Primary outcomes
1
Description
Severity Assessment of Dyspepsia
Timepoint
At baseline,at 2,4,12 weeks
Method of measurement
The Gastrointestinal Symptom Scale
2
Description
Quality of life
Timepoint
At Baseline؛ at 12 Weeks
Method of measurement
SF-36 Questionnaire
Secondary outcomes
1
Description
Side Effects
Timepoint
During the 12-week follow-up study
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Pimpinella Anise 3g plus white sugar 1g ؛ For 4 weeks؛ Three times daily after meals
Category
Treatment - Drugs
2
Description
placebo: Corn starch powder 3g plus white sugar 1g ؛ For 4 weeks، Three times a daily after meals
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Digestive Health Center
Full name of responsible person
Mohammad Mazaheri
Street address
Shariati Ave.
City
Isfehan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad bagher Minaee
Street address
Traditional Medicine Faculty؛ Behesht Ave؛ Vahdate Islami Ave؛ Enghelab Square.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Position
Resident ph.D of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Traditional Medicine Faculty؛ Behesht Ave؛ Vahdate Islami Ave.
City
Tehran
Postal code
Phone
+98 31 1792 2712
Fax
Email
mazaherimohammad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Pyman Adibi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Research Council of Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
adibi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Position
Resident ph.D of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Hezargrib Ave.
City
Isfahan
Postal code
Phone
+98 31 1792 3060
Fax
Email
mazaherimohammad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)