Effect of Rose oil on Gastro-esophageal Reflux Disease in comparison with omeprazole capsule

Effect of rose oil (Rosa damascena) softgel on cardinal manifestations of patients with gastro-esophageal reflux disease in comparison with omeprazole capsule, a double blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014101119489N1

Enrollment

Registered

2016-06-11

Start date

2015-12-26

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal reflux disease. Gastro-oesophageal reflux disease

Interventions

Intervention 1: Intervention group: Rose oil softgel- two softgels TDS orally + one placebo capsule (once daily). Duration of consumption: 20 days - Rose oil softgel is manufactured by Barij Essenc

Treatment - Drugs

Intervention group: Rose oil softgel- two softgels TDS orally + one placebo capsule (once daily). Duration of consumption: 20 days - Rose oil softgel is manufactured by Barij Essence Co. - Plac

Intervention group2 (Control group): One 20 mg omeprazole capsule (once daily) + placebo softgel (two softgels TDS). Duration of consumption: 20 days -omeprazole capsule is manufactured by Dr. Abi

Eligibility

Sex/Gender

All

Age

16 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients between 16 to 80 years old; Patients have at least 12 weeks history of GERD; No history of barrett's esophagus; No history of surgery on esophagus or stomach; No history of any cancer in esophagus, stomach or abdomen; No coagulation problem unable to withdrawal of drugs; No use of glucocorticoids and NSAIDs more than 3 days a week during last 28 days; No sucralfate use during 3 days before study; No aspirin use more than 150 mg daily; No active peptic ulcer or its complications; No antibiotic use for H. pylori eradication during last 28 days; No Cigarette smoking or alcohol drinking; Absence of any GERD complication. Exclusion criteria: Appearance of drug adverse effects; Loss of patient compliance

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Numbers of regurgitation episodes. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.;Numbers of heartburn episodes. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.;Severity of regurgitations. Timepoint: Onset of intervention and twice 10 and 20 days later. Method of measurement: History taking.;Severity of heartburns. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.	—

Measure

Time frame

Numbers of regurgitation episodes. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.;Numbers of heartburn episodes. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.;Severity of regurgitations. Timepoint: Onset of intervention and twice 10 and 20 days later. Method of measurement: History taking.;Severity of heartburns. Timepoint: Onset of intervention and 10 and 20 days later. Method of measurement: History taking.

—

Secondary

Measure	Time frame
Age. Timepoint: at the beginning of the survey. Method of measurement: ID information.;Sex. Timepoint: at the beginning of the survey. Method of measurement: inspection.;Duration of drug use. Timepoint: In 10 days intervals. Method of measurement: Patient statements.;Side effects. Timepoint: Twice in 10-day intervals. Method of measurement: History and physical exams.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Mahdi Ahmadian-Attari Pharm D

Barij Essence Pharmaceutical Co.

ahmadian-attari@gmail.com+98 21 4427 1724

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026