Plain English Summary
Background and study aims
Digestive problems are among the most frequent reasons for patients to visit primary health care. The most common symptoms include dyspepsia-like symptoms and irritable-bowel-syndrome-(IBS) like symptoms. Dyspepsia (indigestion) is pain or discomfort in the stomach and under the ribs. Irritable bowel syndrome (IBS) is a long-term condition that can cause stomach cramps, bloating, diarrhoea and/or constipation. Treatments derived from aromatic plants may reduce these symptoms. The aim of this study is to find out whether droplets derived from a specific combination of aromatic plants reduce dyspepsia-like and IBS-like symptoms.
Who can participate?
Patients aged over 18 with dyspepsia-like or IBS-like symptoms
What does the study involve?
Participants are divided into two groups according to the nature of their symptoms (dyspepsia-like symptoms or IBS-like symptoms). Within these groups participants are randomly allocated to receive either droplets derived from aromatic plants or placebo (dummy) droplets. Participants take the droplets by mouth once a day for four weeks. Dyspepsia-like symptoms or IBS-like symptoms are assessed at the start of the study and after four weeks.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants. All ingredients of the droplets have been consumed for centuries in Crete.
Where is the study run from?
University of Crete (Greece)
When is the study starting and how long is it expected to run for?
March 2017 to September 2017
Who is funding the study?
University of Crete (Greece)
Who is the main contact?
Prof. Christos Lionis
Trial website
Contact information
Type
Scientific
Primary contact
Prof Christos Lionis
ORCID ID
http://orcid.org/0000-0002-9324-2839
Contact details
Clinic of Social and Family Medicine
Faculty of Medicine
Heraklion
71003
Greece
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16251
Study information
Scientific title
The use of aromatic plants in reducing the severity of functional gastro-intestinal tract symptoms: a randomised controlled trial
Acronym
APLI-GtS
Study hypothesis
This intervention may reduce the severity of dyspepsia-like and IBS-like symptoms in patients suffering from GI tract functional problems.
Ethics approval
Bioethics Committee, 7th Health Region of Greece, No 14726/11-10-16, 03/11/2016, ref: 16251
Study design
Proof-of-concept two-arm placebo-controlled pre-/post-evaluation trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
GI-tract functional problems including dyspepsia-like and IBS-like symptoms
Intervention
Patients will be divided into two arms according to the nature of their symptoms (Arm A: dyspepsia-like symptoms, Arm B: IBS-like symptoms). The randomization is a block randomization with age group and gender strata. It is generated using R-statistics and blockrand command. Patients within the two arms of the study will be randomized into two groups:
1. The intervention group receive droplets derived from aromatic plants. The aromatic plants that will be used are Origanum vulgare subsp. Hirtum and/or Origanum onites, Salvia fruticosa and/or Salvia officinalis and Origanum dictamnus. The mixture will be resolved in virgin-olive oil in droplets of 0.5 mg each.
2. The control group receive a placebo droplet
The dosage given is 0.5 ml, once per day, droplet per os. The duration of the study will be four weeks.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Severity of dyspepsia-like symptoms, assessed using the COLRAD questionnaire at baseline and after one month of administration
Secondary outcome measures
Severity of IBS-like symptoms, assessed using the IBS-SSS questionnaire at baseline and after one month of administration
Overall trial start date
02/03/2017
Overall trial end date
31/01/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participant aged >18 years
2. Suffering from GI-tract discomfort such as dyspepsia-like and/or IBS-like symptoms
3. Patients not receiving any other medication for the GI-tract symptoms in the previous two weeks
4. Pregnant women
5. Patients with history of cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72 individuals (36 participants in each arm, with each arm comprised of two groups of 18 patients)
Participant exclusion criteria
1. Participant does not have capacity to complete study questionnaire
2. Participant is under the age of 18
3. Participant currently receiving medication for his/her treatment or deny
Recruitment start date
03/04/2017
Recruitment end date
15/12/2017
Locations
Countries of recruitment
Greece
Trial participating centre
University of Crete
Clinic of Social and Family Medicine
Faculty of Medicine
PO Box 2208
Heraklion
71003
Greece
Sponsor information
Organisation
University of Crete
Sponsor details
Clinic of Social and Family Medicine
Faculty of Medicine
PO Box 2208
Heraklion
71003
Greece
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
University of Crete
Alternative name(s)
UoC
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Greece
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal is expected at the end of 2018.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Christos Lionis.
Intention to publish date
31/12/2018
Participant level data
Available on request
Results - basic reporting
Publication summary