This study is designed to evaluate the efficacy of Pistacia atlantica Resin 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 Functional dyspepsia. This randomized, double-blind, placebo-controlled trial will be performed at one University center and will include Pistacia atlantica Resin and placebo (suger) group. Each group will consist of 48 Functional dyspepsia patients. four weeks of administration of Pistacia atlantica Resin or placebo will be conducted. During the subsequent 1 months, follow-up observations of primary and secondary outcomes will be performed. The primary outcomes and the secondary outcomes are differences as measured on the Nepean Dyspepsia Index for dyspepsia and on the questionnaire for Functional Dyspepsia-related quality of life. All outcomes will be measured at baseline, at 2, 4 weeks of treatment, and at the 1 month follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031327033N1
Registration date:2016-06-11, 1395/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Mahdiyehsadat Eftekharafzali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 0360
Email address
m.eftekharafzali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of "Pistacia atlantica" resin (Bane) on clinical symptoms of
patients with Functional Dyspepsia
Public title
ُThe efficacy of Bane on patients with Functional Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients within 18-60 years old with Functional Dyspepsia؛ No history of peptic ulcer or Reflux ؛The absence of an underlying disease, including heart failure, renal failure, cirrhosis, diabetes, hypothyroidism; No history of abdominal surgeries ؛Exclusion Criteria: Using of chemical and herbal drugs؛ Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
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
Ethics Committe of Kerman University of Medical Sciences
Street address
Shafa Crossroad; Jomhuri Boulevard
City
kerman
Postal code
۰۰۹۸
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.KMU.AH.REC.1395.10
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
k30
ICD-10 code description
indigestion
Primary outcomes
1
Description
severity assessment of dyspepsia
Timepoint
at baseline, 2, 4, 8 weeks
Method of measurement
the gastrointestinal symptom scale
Secondary outcomes
1
Description
quality of life
Timepoint
at baseline, 2, 4, 8 weeks
Method of measurement
NDI10 quality of life scale
Intervention groups
1
Description
pistachia atlantica capsules 500 mg orally , twice daily for a month
Category
Treatment - Drugs
2
Description
Placebo capsules 500 mg orally , twice daily for a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur hospital
Full name of responsible person
Dr. zahedi mohammad javad
Street address
Emam high way
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Medical University of Sciences
Full name of responsible person
Kerman Medical University of Sciences
Street address
Jomhuri boulevard
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?