Aromatic plant intervention for gastrointestinal tract symptoms
| ISRCTN | ISRCTN31202330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31202330 |
| Secondary identifying numbers | 16251 |
- Submission date
- 22/03/2017
- Registration date
- 28/03/2017
- Last edited
- 25/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Clinic of Social and Family Medicine
Faculty of Medicine
Heraklion
71003
Greece
 ORCID ID |
0000-0002-9324-2839 |
|---|
Study information
| Study design | Proof-of-concept two-arm placebo-controlled pre-/post-evaluation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The use of aromatic plants in reducing the severity of functional gastro-intestinal tract symptoms: a randomised controlled trial |
| Study acronym | APLI-GtS |
| Study objectives | This intervention may reduce the severity of dyspepsia-like and IBS-like symptoms in patients suffering from GI tract functional problems. |
| Ethics approval(s) | Bioethics Committee, 7th Health Region of Greece, No 14726/11-10-16, 03/11/2016, ref: 16251 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/03/2017 |
| Completion date | 31/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 individuals (36 participants in each arm, with each arm comprised of two groups of 18 patients) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/04/2017 |
| Date of final enrolment | 15/12/2017 |
Locations
Countries of recruitment
- Greece
Study participating centre
Faculty of Medicine
PO Box 2208
Heraklion
71003
Greece
Sponsor information
Research organisation
Clinic of Social and Family Medicine
Faculty of Medicine
PO Box 2208
Heraklion
71003
Greece
| Website | http://www.fammed.uoc.gr/Joomla/ |
|---|---|
"ROR" |
https://ror.org/00dr28g20 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- UoC
- Location
- Greece
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
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.
