]>
IRCT20090804002288N14 IRCT 2018-07-16 Iranian academic center for education culture and research Effects of Pistacia atlantica oleoresin in treatment of functional dyspepsia Comparison of efficacy of Pistacia atlantica L. oleoresin with that of placebo in treatment of patients with functional dyspepsia 2018-09-23 anticipated 100 Complete https://irct.ir/trial/32430 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of ten patients are used for the treatment assignments, Blinding description: Three different persons generate the random allocation sequence, enroll the participants and assign them to intervention groups. These persons, care providers, outcome assessors, data analyzer, investigators and participants are blinded to assignment to the Pistacia atlantica oleoresin and placebo groups. 3 Functional dyspepsia. Intervention 1: Intervention group: Pistacia atlantica oleoresin is administered to a group of 50 patients at the dose of two 200 mg capsules every 12 hours for 2 month. Intervention 2: Control group: Two placebo capsules are administered to another group of 50 patients every 12 hours for 2 months. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD are to be shared. When: Access period starting 6 months after publication for 1 year. To whom: Researchers working in university and scientific and industrial institutes. Conditions: Only statistical analyses mentioned in the article resulting from the study for personal knowledge are permitted. Written request for access to data and documents and its aim must be certified by the highest ranking official of the work place of the requester. Where to obtain: Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran. How to obtain: Written request should be sent to the address Dr. Saeed Kianbakht, ACECR Institute of Medicinal Plants, P.O. Box: 31375-369, Iran. The documents or data file will be sent to the requester by email. Comments:
public Dr. Saeed Kianbakht
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 kianbakht@imp.ac.ir Iranian academic center for education culture and research scientific Dr. Saeed Kianbakht
]nstitute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26 3476 4010 kianbakht@imp.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Patients aged 20 to 80 Patients with functional dyspepsia according to the ROME III criteria Patients without organic, systemic and metabolic diseases causing dyspepsia 20 years 80 years Both Pregnant women Women planning pregnancy Breast-feeding women K30 Functional dyspepsia Treatment - Drugs Placebo Intervention group: Pistacia atlantica oleoresin is administered to a group of 50 patients at the dose of two 200 mg capsules every 12 hours for 2 month. Control group: Two placebo capsules are administered to another group of 50 patients every 12 hours for 2 months. Dyspepsia. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Hong Kong dyspepsia index questionnaire. 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. Iranian academic center for education culture and research Approved 2018-01-16 Ethics committee of Avicenna Research Institute Avicenna Resrach Institute, Shaheed Beheshti University, Darakeh Street Tehran Tehran Iran (Islamic Republic of)