Condition category
Digestive System
Date applied
22/03/2017
Date assigned
28/03/2017
Last edited
25/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measure

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 (if study stopped)

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

http://www.fammed.uoc.gr/Joomla/

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/07/2017 to 15/12/2017. 2. The overall trial end date was changed from 01/09/2017 to 31/01/2018.