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Effect of Rose and valerian tablet and Omeprazole capsule on the adult reflux symptoms

Comparative study of the effect of Rose and valerian tablet and Omeprazole capsule on the adult reflux symptoms: A double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161031030616N4
Enrollment
72
Registered
2025-04-28
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

reflux. Gastro-esophageal reflux disease

Interventions

Intervention 1: First intervention group: Combination tablets of rose and valerian, one tablet after breakfast (For 6 weeks, Manufactured by Niak Pharmaceutical), and placebo omeprazole capsules,One t

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The age of the patient is between 18 and 60 years Reflux diagnosis based on ROME IV criteria and endoscopy without specific pathological findings Symptoms began at least 6 months ago and symptoms were present at least 2 days a week for the past 3 months The patient is not infected with Helicobacter pylori. No use of antibiotics and Proton Pump Inhibitors (PPIs) in the last 1 month

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Nonsteroidal Anti-Inflammatory Drugs (NSAID) or aspirin use Underlying diseases including heart failure; kidney failure; cirrhosis

Design outcomes

Primary

MeasureTime frame
Heartburn. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Heaviness after Eating. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Abdominal bloating. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Discomfort after Eating. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Unusual feeling and rise of Bitter liquid in the throat. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Dysphagia. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Belch. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Early satiety. Timepoint: At baseline, 2, 6 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGorgan University of Medical Sciences

Gorgan University of Medical Sciences

dr.kolaangi@gmail.com+98 17 3243 0310

Outcome results

None listed

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