Determination of the efficacy of Mastic oil on symptoms of dyspepsia symptoms in patients with functional dyspepsia
Design
Clinical trials with control group, with parallel groups, triple-blind, randomized
Settings and conduct
questionnaire
Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Severity of functional dyspepsia symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090527001957N8
Registration date:2019-08-22, 1398/05/31
Registration timing:registered_while_recruiting
Last update:2019-08-22, 1398/05/31
Update count:1
Registration date
2019-08-22, 1398/05/31
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-16, 1398/01/27
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical Pistacia lentiscus oil in patients with functional dyspepsia
Public title
Effect of Pistacia lentiscus in functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research in Pharmaceutical Sciences and Pharmaceutical Sciences, Islamic Azad Un
Street address
Tehran, Ghods Town, between South Falamak and Zarafshan, Iran's Simay Avenue, Headquarters of the Ministry of Health and Medical Education, Block A, Thirteenth Class
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.IAU.PS.REC.1397.322
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Severity of Dyspepsia symptoms
Timepoint
Before the intervention, the end of the first month
Method of measurement
One and two Dyspepsia questionnaire
Secondary outcomes
1
Description
early satiation, postprandial fullness
Timepoint
at the beginning and the end of the study
Method of measurement
checklist of symptoms
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini gastroenterology center
Full name of responsible person
Mahsa Baradaran sattarzadeh
Street address
Tehran, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 2277 3592
Email
mahsa.baradaran28@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Ali Ghobadi
Street address
No: 9, purina alley, lalehzar st, jomhuri Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3345 0154
Email
alighobadi56@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Research institute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem-Dabaghian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Community medicine
Street address
No:9, Pirnia Alley, lalehzar st, jomhury Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1145847111
Phone
+98 21 3395 0154
Fax
Email
fataneh.dabaghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Insstitute for Islamic and Complementary Medicine