Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia

Summary

Functional Dyspepsia (FD) is diagnosed in the presence of bothersome epigastric pain or burning, early satiation and/or postprandial fullness of greater than 8 weeks duration, in the absence of alarm signs. Alarm signs include weight loss, gastrointestinal bleeding, anemia, dysphagia, and family history of upper gastrointestinal malignancies. FD is a common gastrointestinal complaint. It's prevalence in Iranian population is reported to be from 2.2% to 29.9% (1). FD should be introduced as a disorder of gut-brain interaction (DGBI), together with a simple account of the gut-brain axis and how this is impacted by diet, stress, cognitive, behavioral and emotional responses to symptoms and post-infective changes. Histamine-2-receptor antagonists, proton pump inhibitors, and prokinetics are introduced as the first line classic treatment in FD. (2) Tricyclic antidepressants (TCAs) used as gut-brain neuromodulators are an efficacious second-line treatment for FD. (2) Antipsychotics, such as sulpiride 100 mg four times a day or levosulpiride 25 mg three times a day, may be efficacious as a second-line treatment for FD. Tandospirone, Pregabalin, Mirtazapine are among the suggested second line pharmachological therapy. (2) FD expresses a spectrum of various upper gastrointestinal complaints. Epigastric pain, retrosternal pain, regurgitation, nausea, vomiting, belching, dysphagia, and early satiety are among the most frequent symptoms. Therefore, a combination of medications might be needed to alleviate the patients' discomfort. The pharmaceutics have proposed the package of medications to increase the patient compliance. "Digestive Aid" is a cocktail that contains Marshmallow, Ginger, Gentian, Fennel, Peppermint, and Anise oil. It is widely used by physicians to control dyspeptic symptoms. There are studies on human and animals that showed the efficacy of mentioned herbal supplements on dyspepsia. To the best of our knowledge there is no study about the efficacy of "Digestive Aid" in the dyspeptic patients. This trial is conducted to evaluate the efficacy of mentioned product in alleviating the symptoms in FD in a sample of the Iranian patients.

Conditions

• Dyspepsia Chronic

Interventions

DIETARY_SUPPLEMENT

Digestive Aid

one tablet daily for one month

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• Darman Yab Darou Co.

  collaborator UNKNOWN

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Raika Jamali, M.D. · Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2025-12-30

Completion

2026-03-31

Countries

• Iran

Study Locations