| June 3, 2017 |
summary |
This is a randomized, double-blind clinical trial with the aim to study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Functional dyspepsia. Study population is the patients that referred to gastroenterology clinic and sample size for study is 50 person. The inclusion criteria are written consent, complete knowledge about the study and being diagnosed with Irritable bowel syndrome based on the ROME III criteria. The exclusion criteria are the participants’ lack of consent to continue their participation in the study, warning symptoms and signs of gastric and intestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease, also, kidney or liver diseases based on patient history, physical examination and medical records. The study will last for 14 days, and the participants will be randomly divided into two groups; namely, the intervention group (receiving capsules containing the essential oil of the plant), and the control group (receiving a placebo containing water scented with the essential oil). Moreover, patient characteristics such as severity of disease symptoms, and quality of life will enter into a form ( prepared in advance) at the beginning, at the end, and two weeks after completion of treatment in order to assess treatment outcome. After completion of the treatment, the safety of the treatment regimen will also be assessed by doing laboratory tests and through recording adverse drug reactions.
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