Herbal drug for treatment of Gastro-esophageal reflux disease

Comparison of the Effectiveness of Omeprazole with herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Gastro-esophageal reflux disease (GERD).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016072129026N1

Enrollment

Registered

2016-12-07

Start date

2016-08-05

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-oesophageal reflux disease. Gastro-oesophageal reflux disease

Interventions

Intervention 1: Intervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks. Intervention 2: Control

Treatment - Drugs

Intervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit, Zataria Multifora and Dill oil, 2 times a day for 2 weeks.

Control group: Prescription of omeprazole 20 mg capsule once a day for 2 weeks

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Written consent and complete knowledge about the study; being diagnosed with Gastro-esophageal reflux disease based on the Montreal definition.

Exclusion criteria

Exclusion criteria: The participants’ lack of consent to continue their participation in the study; kidney and liver diseases based on laboratory tests; warning symptoms of gastric and esophageal cancers, other chronic digestive diseases and peptic ulcer disease based on patient history, physical examination, laboratory tests and, if necessary, upper endoscopy.

Design outcomes

Primary

Measure	Time frame
Average score of persons in (Gastrointestinal SymptomRating Scale (GSRS. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS indigestion score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS abdominal pain. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS Reflux score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Quality of life. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: SF-36 Healthy Survey questionnaire.;Epigastric pain syndrome(EPS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Postprandial distress syndrom(PDS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).	—

Measure

Time frame

Average score of persons in (Gastrointestinal SymptomRating Scale (GSRS. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS indigestion score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS abdominal pain. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Average score of persons in GSRS Reflux score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal SymptomRating Scale (GSRS).;Quality of life. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: SF-36 Healthy Survey questionnaire.;Epigastric pain syndrome(EPS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Postprandial distress syndrom(PDS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).

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Secondary

Measure	Time frame
Amount of drug consumption. Timepoint: after intervention. Method of measurement: By checking the residual amount of drug after intervention.;Elevation of liver enzymes. Timepoint: Before and after intervention. Method of measurement: labratory test(AST,ALT,ALP,Billi T,D).;Dysfunction of kidney. Timepoint: Before and after intervention. Method of measurement: labratory tests(Bun ,Cr).;Drug side effects. Timepoint: During and after intervention. Method of measurement: Entry the side effects by patient andclinical caregiver in side effects form.	—

Measure

Time frame

Amount of drug consumption. Timepoint: after intervention. Method of measurement: By checking the residual amount of drug after intervention.;Elevation of liver enzymes. Timepoint: Before and after intervention. Method of measurement: labratory test(AST,ALT,ALP,Billi T,D).;Dysfunction of kidney. Timepoint: Before and after intervention. Method of measurement: labratory tests(Bun ,Cr).;Drug side effects. Timepoint: During and after intervention. Method of measurement: Entry the side effects by patient andclinical caregiver in side effects form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhasem Bordbar

Student research comitte, Vice-chancellery for research, Hormozgan University of Medical Siences.

ghasem.bordbar@hums.ac.ir+98 76 3333 7192

Outcome results

None listed

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