Herbal Drug for Treatment of Functional Dyspepsia and eradication of Helicobacter pylori(H.pylori) infection.

Efficacy of herbal drug that is composed of essential oil of Zataria Multiflora Boiss, Trachyspermum Ammi and Anethum Graveolens L, in treatment of Functional dyspepsia (FD) and eradication of Helicobacter pylori(H.pylori) infection.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160721029026N4

Enrollment

Registered

2017-12-31

Start date

2017-03-20

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

Functional Dyspepsia. Dyspepsia

Interventions

Intervention 1: Intervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 3 times a day for 20 days. Intervention 2: Control gro

Treatment - Drugs

Intervention group: Prescription of edible capsule containing 180mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 3 times a day for 20 days.

Control group: Prescription of Clarithromycin 500mg twice a day for 2 weeks, Amoxicillin 1gr twice a day for 2 weeks and Omeprazole 20 mg capsule once a day for 4 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 Functional dyspepsia based on the ROME III criteria; The presence of H.pylori infection based on Stool antigen test.

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 Symptom Rating Scale (GSRS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Average score of persons in GSRS abdominal pain. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Epigastric pain syndrome(EPS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Average score of persons in GSRS indigestion score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Postprandial distress syndrom. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Quality of life. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: SF-36 Healthy Survey questionnaire.;Eradication oh H.pylori infection. Timepoint: Before intervention, 2 weeks after intervention. Method of measurement: Stool Ag test.	—

Measure

Time frame

Average score of persons in Gastrointestinal Symptom Rating Scale (GSRS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Average score of persons in GSRS abdominal pain. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Epigastric pain syndrome(EPS). Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Average score of persons in GSRS indigestion score. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).;Postprandial distress syndrom. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: VAS Score(0-10).;Quality of life. Timepoint: Before intervention, end of intervention, 2 weeks after intervention. Method of measurement: SF-36 Healthy Survey questionnaire.;Eradication oh H.pylori infection. Timepoint: Before intervention, 2 weeks after intervention. Method of measurement: Stool Ag test.

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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 an after intervention. Method of measurement: Entry the side effects by patient and Responsible for study 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 an after intervention. Method of measurement: Entry the side effects by patient and Responsible for study 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.

bordbarghasem1@yahoo.com+98 76 3333 7192

Outcome results

None listed

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