The effect of Rosa damascena combined tablet on functional dyspepsia

Formulation development of a combined tablet of Rosa damascena, and investigating its effectiveness on the clinical symptoms of functional dyspepsia patients: a randomized. Double-blind controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241208063983N1

Enrollment

Registered

2024-12-25

Start date

2025-01-11

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Functional dyspepsia. Functional dyspepsia

Interventions

Intervention 1: Intervention group:combined vard tablet consisting of rose and dried rhizomes of licorice and valerian, with a dose of 500 mg, three times a day (after meals) for four weeks. The drug

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years with complaints of indigestion Diagnosis of functional dyspepsia based on IV Rome criteria by specialist digestion Positiveness of Helicobacter pylori infection

Exclusion criteria

Exclusion criteria: History of peptic ulcer Endoscopic with specific pathological findings Presence of underlying diseases including heart failure, high blood pressure, kidney failure and uremic disease, cirrhosis, History of abdominal surgery Any type of malignancy History of chemotherapy and radiotherapy, or exposure to exposed to radioactive radiation, Pregnancy and breastfeeding, Negative test for Helicobacter pylori infection Use of NSAIDs and any type of herbal medicine Smoking and alcohol use, History of any allergy to product components.

Design outcomes

Primary

Measure	Time frame
The effect of "Rosa Damascena tablet" on the severity of indigestion symptoms based on the total score of the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: GSRS Questionnaire.;The effect of "Rosa Damascena tablet "on the symptoms of early satiety and heart fullness from the Rome III Persian questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: Farsi version of Rome III diagnostic questionnaire.	—

Measure

Time frame

The effect of "Rosa Damascena tablet" on the severity of indigestion symptoms based on the total score of the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: GSRS Questionnaire.;The effect of "Rosa Damascena tablet "on the symptoms of early satiety and heart fullness from the Rome III Persian questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: Farsi version of Rome III diagnostic questionnaire.

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Secondary

Measure	Time frame
Severity of gastrointestinal symptoms in each of the 5 subgroups of symptoms of the Gastrointestinal Symptom Rating Scale questionnaire and symptoms related to postprandial pain syndrome. Timepoint: Before the start of the intervention, the second, fourth, and eighth weeks after the start. Method of measurement: GSRS questionnaire for the severity of gastrointestinal symptoms.;Sleep quality score. Timepoint: The beginning of the study, the fourth week, the eighth week. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI).	—

Measure

Time frame

Severity of gastrointestinal symptoms in each of the 5 subgroups of symptoms of the Gastrointestinal Symptom Rating Scale questionnaire and symptoms related to postprandial pain syndrome. Timepoint: Before the start of the intervention, the second, fourth, and eighth weeks after the start. Method of measurement: GSRS questionnaire for the severity of gastrointestinal symptoms.;Sleep quality score. Timepoint: The beginning of the study, the fourth week, the eighth week. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnam Danesh

Babol University of Medical Sciences

beh.danesh@gmail.com+98 11 3219 4730

Outcome results

None listed

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