Dyspepsia. Dyspepsia
Conditions
Interventions
Intervention 1: Pennyroyal leaf extract is administered to a group of about 50 patients at the dose of one 330 mg capsule every 8 hours for 2 month. Intervention 2: one placebo capsule is administered
Treatment - Drugs
Placebo
Pennyroyal leaf extract is administered to a group of about 50 patients at the dose of one 330 mg capsule every 8 hours for 2 month.
one placebo capsule is administered to another group of about 50 patients every 8 hours for 2 months.
Sponsors
Vice Chancellor for research of ACECR Institute of Medicinal Plants
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: patients aged 20 to 80; patients with functional dyspepsia according to the ROME III criteria; patients in whom upper gastrointestinal endoscopy has not shown any organic causes of dyspepsia; patients without organic, systemic and metabolic diseases causing dyspepsia. Exclusion criteria: patients with peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, pure gastro-esophageal reflux disease and any organic gastrointestinal disease; patients with a history of Helicobacter pylori infection eradicating drugs use within the past 3 months; patients with a history of gastrointestinal system surgery; patients with background systemic diseases such as diabetes mellitus, heart failure, hepatic failure, renal failure, asthma, chronic obstructive pulmonary disease, neoplasms and severe psychiatric diseases; patients addicted to alcohol and opium; patients using cardiac, antihypertensive, antipsychotic, antianxiety, antibiotic and corticosteroid drugs and iron and calcium; patients with a history of discontinuing prescribed pharmacotherapy and incomplete treatment; pregnant women; women planning pregnancy; breast-feeding women.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspepsia. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Hong Kong dyspepsia index questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Before intervention and 2 months after intervention. Method of measurement: SF-36 questionnaire.;Helicobacter pylori infection. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Urease test.;Adverse drug reactions. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Patient questioning. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Saeed Kianbakht
ACECR Institute of Medicinal Plants
Outcome results
None listed