Evaluation of Effectiveness of Mastic Gum in Functional Dyspepsia
| ISRCTN | ISRCTN51942129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51942129 |
| Protocol serial number | MGCGH0031 |
| Sponsor | Mastic Gum Producers Cooperative (Greece) |
| Funder | Mastic Gum Producers Cooperative (Greece) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Total symptom score changes, measured once at the end of treatment. |
| Key secondary outcome measure(s) |
Individual symptom changes, measured once, at the end of treatment. |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
