Protocol summary
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Study aim
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Determination of the efficacy of Mastic oil on symptoms of dyspepsia symptoms in patients with functional dyspepsia
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Design
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Clinical trials with control group, with parallel groups, triple-blind, randomized
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Settings and conduct
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questionnaire
Imam Khomeini Hospital
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Participants/Inclusion and exclusion criteria
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Criteria for inclusion in the study include:
The existence of functional dyspepsia symptoms based on ROMVI criteria
; Functional Dyspepsia with the overcoming of the sign: postprandial fullness and early satiation
; Both sexes
; Aged 18 to 60 years
; Negative Helicobacter pylori (determined by endoscopy)
; Written informed consent
Non-inclusion criteria include:
Dyspepsia with overwhelming heartburn symptoms
; Alert symptoms: Progressive weight loss without diet, Gastrointestinal bleeding in the form of blood vomiting, ricket stool, or iron deficiency anemia, progressive dysphagia (dysphagia) or painful ingestion (oedinophagia), repeated vomiting or food back, abdominal mass, lymphadenopathy or ascites
; Family history of gastric cancer in relatives of first degree relatives
; IBD
; Duodenitis
; Gastritis
; Peptic ulcer
; Reflux (the most important complaint)
; Taking NSAIDs or corticosteroids for more than a month
; GI outlet blockage on endoscopy
; GI malignancy
; History of gastric surgery
; Pregnancy and lactation
; Chronic diseases of the heart, kidney, liver, gallbladder
; Diabetes, and other metabolic diseases that cause dyspepsia.
; Smoking and Alcohol consumption
; BMI higher than 30
; Use of other herbal chemicals for Disopecia
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Intervention groups
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The Intervention group 1: Mastic oil group, patients in this group consume Mastic oil.
The intervention group 2: The placebo group, patients in this group take placebo.
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Main outcome variables
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Severity of functional dyspepsia symptoms
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090527001957N8
Registration date:
2019-08-22, 1398/05/31
Registration timing:
registered_while_recruiting
Last update:
2019-12-26, 1398/10/05
Update count:
1
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Registration date
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2019-08-22, 1398/05/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-16, 1398/01/27
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the efficacy of topical Pistacia lentiscus oil in patients with functional dyspepsia
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Public title
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Effect of Pistacia lentiscus in functional dyspepsia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Negative H. pylori infection in endoscopy
Occurrence of functional Dyspepsia based on ROME IV criteria
Written informed consent
Possibility of patient tracking
Exclusion criteria:
IBD disease
Esophagitis, gastritis, duodenitis
Gastric ulcer, gastrointestinal bleeding
Reflux (the most important complaint)
Gastrointestinal outlet obstruction in the endoscopy
Gastrointestinal malignancy or gastric malignancy in first-degree relative affinity
History of gastric surgery
Chronic diseases of the heart, kidney, liver, gallbladder
Diabetes and other metabolic diseases that cause dyspepsia
Iron deficiency anemia
Progressive Weight Loss Without Diet
BMI higher than 30, pregnancy or intent to be pregnant and breastfeeding
Smoking and alcohol consumption
Taking NSAIDs or corticosteroids for more than a month
Consumption of other herbal medicines, chemical for Dyspepsia
Dyspepsia caused by drugs
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Blocks randomization method is used and blocks are randomly selected by using the table of random numbers. Allocation concealment will be carried out using sealed envelopes.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Mastic oil and placebo are prepared in similar containers.Therefore, the participants during the trial, data collectors, outcome assessors, analyser and authors of the article are not aware of the type of drug and placebo.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-30, 1397/10/09
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Ethics committee reference number
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IR.IAU.PS.REC.1397.322
Health conditions studied
1
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Description of health condition studied
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Functional dyspepsia
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ICD-10 code
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K30
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ICD-10 code description
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Functional dyspepsia
Primary outcomes
1
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Description
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Severity of Dyspepsia symptoms
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Timepoint
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Before the intervention, the end of the first month
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Method of measurement
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One and two Dyspepsia questionnaire
Secondary outcomes
1
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Description
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early satiation, postprandial fullness
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Timepoint
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at the beginning and the end of the study
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Method of measurement
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checklist of symptoms
Intervention groups
1
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Description
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First intervention group: Mastic oil, which is made from a combination of 134 grams of Mastic gum and 536 grams of Sesame oil, topically applied three times a day after meals, and each time 10 drops are applied to the epigastric area for 4 weeks.
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Category
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Treatment - Drugs
2
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Description
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The second intervention group: Placebo containing only Sesame oil, which is taken topically 3 times a day after meals, and 10 drops per episode area for 4 weeks each time.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Institute for Islamic and Complementary Medicine
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available