Evaluation of Effectiveness of Mastic Gum in Functional Dyspepsia
| ISRCTN | ISRCTN51942129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51942129 |
| Secondary identifying numbers | MGCGH0031 |
- Submission date
- 18/04/2007
- Registration date
- 30/04/2007
- Last edited
- 09/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Konstantinos Dabos
Scientific
Scientific
Demokratias 5
Chios
821-00
Greece
| Phone | +30 2271 028 729 |
|---|---|
| kostasophia@yahoo.com |
Study information
| Study design | Prospective randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | EEMGFD |
| Study objectives | Mastic gum improves symptoms in functional dyspepsia. |
| Ethics approval(s) | Approval received from the North Aegean scientific research committee in October 2006 (ref: 165/06). |
| Health condition(s) or problem(s) studied | Functional dyspepsia |
| Intervention | Patients will be given either pure mastic gum in capsule form containing 350 mg or placebo capsules, twice daily. Patients will have treatment for three weeks. For safety reasons there will be a follow up visit four weeks later. |
| Intervention type | Other |
| Primary outcome measure | 1. Total symptom score changes, measured once at the end of treatment. 2. Global assessment of symptoms, measured once at the end of treatment. |
| Secondary outcome measures | Individual symptom changes, measured once, at the end of treatment. |
| Overall study start date | 01/05/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 140 |
| Key inclusion criteria | 1. Rome II criteria for functional dyspepsia 2. Negative Helicobacter pylori status 3. Negative gastroduodenoscopy |
| Key exclusion criteria | 1. Primarily symptoms of Gastro-Oesaphageal Reflux Disease (GORD) 2. On prokinetic drugs 3. Suffering from Gastrointestinal (GI) malignancy |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Greece
Study participating centre
Demokratias 5
Chios
821-00
Greece
821-00
Greece
Sponsor information
Mastic Gum Producers Cooperative (Greece)
Industry
Industry
Konstantinou Monomahou 1
Chios
821-00
Greece
| Website | http://www.gummastic.gr |
|---|---|
"ROR" |
https://ror.org/05rpby975 |
Funders
Funder type
Industry
Mastic Gum Producers Cooperative (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/02/2010 | Yes | No |
