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Evaluation of the effectiveness of a herbal product containing Rhus Coriaria L. (Sumac) and Pimpinella Anisum (Anise) in patients with Gastroesophageal Reflux compared to placebo

Evaluation of the effectiveness of a herbal product containing Rhus Coriaria L. (Sumac) and Pimpinella Anisum (Anise) in patients with Gastroesophageal Reflux compared to placebo: A double-blind Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231008059650N1
Enrollment
70
Registered
2023-10-31
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Gastroesophageal Reflux. Diseases of oesophagus, stomach and duodenum

Interventions

Intervention 1: Intervention group: In the medicine group, we put 3 grams of medicine (1.5 grams of brown sumac and 1.5 grams of anise) as a mixture, divided into 6 capsules of 500 mg and 2 tablets ar

Sponsors

Institute of Medical History, Islamic and Complementary Medicine Studies
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who have gastroesophageal reflux symptoms at least once a week (Heartburn and Regurgitation) Patients who do not complication from gastroesophageal reflux disease. People who have been diagnosed with reflux disease and have not taken medicine in the last 2 weeks and want to start anti-reflux treatment again.

Exclusion criteria

Exclusion criteria: Patients with regular glucocorticoid intake Pregnancy Breastfeeding The presence of signs and symptoms of danger in the patient's history, such as weight loss of more than 10% during the last three months Patients with a history of Barrett's disease History of esophageal, stomach, or intestinal cancer Patients with coagulation disorders Patients with acute peptic ulcer or its complications

Design outcomes

Primary

MeasureTime frame
Severity of heartburn based on (QOLRAD) (FSSG). Timepoint: Severity of Heartburn before the start of the intervention, 2 and 4 weeks after the start of the intervention;. Method of measurement: Severity of Heartburn based on (FSSG) frequency scale for the symptoms of GERD ? (QOLRAD) Quality Of Life in Reflux and Dyspepsia.;Frequency of Heartburn based on (QOLRAD) (FSSG). Timepoint: Frequency of Heartburn before the intervention, 2 and 4 weeks after the intervention;. Method of measurement: Frequency of Heartburn based on (FSSG) frequency scale for the symptoms of GERD ? (QOLRAD) Quality Of Life in Reflux and Dyspepsia.;Severity of Regurgitation based on (QOLRAD) (FSSG). Timepoint: Severity of Regurgitation before the start of the intervention, 2 and 4 weeks after the start of the intervention;. Method of measurement: Severity of Regurgitation based on (FSSG) frequency scale for the symptoms of GERD ? (QOLRAD) Quality Of Life in Reflux and Dyspepsia.;Frequency of Regurgitation based on (QOLRAD) (FSSG). Timepoint: Frequency of Regurgitation before the intervention, 2 and 4 weeks after the intervention;. Method of measurement: Frequency of Regurgitation based on (FSSG) frequency scale for the symptoms of GERD ? (QOLRAD) Quality Of Life in Reflux and Dyspepsia.

Secondary

MeasureTime frame
Stomach temperament in terms of coldness, warmth, dryness and humidity. Timepoint: Before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: Stomach temperament questionnaires.;Drug side effects. Timepoint: Week 2 and 4 after the intervention. Method of measurement: Medication side effects questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMalihe zaman Momeniha

Iran University of Medical Sciences

momenihamalihezaman@gmail.com+98 21 5515 2191

Outcome results

None listed

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