Functional dyspepsia (FD) 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. In Traditional Iranian medicine, Wild Mint (SN: Mentha Longifolia؛ LN: Pune ) has long been one of the most frequently prescribed for treating dyspepsia and bloating. The current study is designed to evaluate the efficacy and safety of Wild Mint for FD patients.
Methods: This randomized, double-blind, placebo-controlled trial will be performed at one center and will include A Wild Mint capsule group and placebo (corn) group. Each group will consist of 50 FD patients . four weeks of administration of Wild Mint 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 symptom 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:IRCT2013043013183N1
Registration date:2013-06-03, 1392/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Mahmoud Babaeian
Name of organization / entity
Shahed University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 2313
Email address
drbabaeian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahed University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of Wild Mint product in Postprandial Distress Syndrome
Public title
Effect of Wild Mint product in Postprandial Distress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with 18-65 old years؛ Early Satiety؛ bothersome postprandial fullness؛ Without Organic Disorders on physical examination and Endoscopic
Exclusion criteria: Patients with organic disorders؛ The use of Chemicals and Herbals any other medication؛ History of Abdominal surgeries؛ History of bloody diarrhea؛ Pregnancy and lactation؛ Lack of interest in work؛ Not sign the consent
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
1
Registry name
NO
Secondary trial Id
NO
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University of Medical Sciences
Street address
Abdolahzadeh Ave؛ Tehran
City
Tehran
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
41/1681152
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: Wild Mint Capsules 500 mg؛ For 4 weeks؛ Three times daily after meals
Category
Treatment - Drugs
2
Description
placebo: Corn starch Capsules 500 mg؛ 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
Mahmoud Babaeian. MD
Street address
Shariati Ave.؛ Hakim Nezami Ave.
City
Isfehan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahed University of Medical Sciences
Full name of responsible person
Mohsen Naseri.MD
Street address
Traditional Medicine Clinical Trial Research Center؛ No.1471 ؛ Between Forsat and Nosrat Ave؛ North Kargar Ave؛ Enghelab Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahed 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
Shahed University of Medical Sciences
Full name of responsible person
Mahmoud Babaeian
Position
Resident ph.D of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Tim Health care؛ Third Dashtestan Ave؛ Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drbabaeian@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. MD
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
+98 31 1668 7898
Email
adibi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Mahmoud Babaeian
Position
Resident of Ph.D Iranian Traditional Medicine
Other areas of specialty/work
Street address
Third Dashtestan Ave؛ Shariati Ave؛ Tehran.
City
Tehran
Postal code
Phone
+98 21 2288 2521
Fax
Email
drbabaeian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)