Evaluating the Efficacy of "Digestive Aid" in Functional Dyspepsia

NCT06958952 | Recruiting DMC

• 1 other identifier: 1403-4-101-75896
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Efficacy; Clinical trial; Functional Dyspepsia; questionnaire; Digestive Aid

Outcome Measures

Primary Outcomes (1)

• Functional Dyspepsia

  Functional Dyspepsia evaluation based on the Leeds Dyspepsia Questionnaire (LDQ)

  One month

Study Arms (2)

Digestive Aid

EXPERIMENTAL

Treatment with Digestive Aid

Dietary Supplement: Digestive Aid

Placebo

PLACEBO COMPARATOR

Treatment with placebo

Dietary Supplement: Placebo

Interventions

Digestive Aid DIETARY_SUPPLEMENT

one tablet daily for one month

Digestive Aid

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The new onset dyspeptic patients

You may not qualify if:

• Participants with co-morbidities (known GI diseases)
• Taking medications,
• Those with abnormal gastrointestinal findings in physical examination and para-clinical investigations

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Darman Yab Darou Co.: collaborator

Study Sites (1)

Sina Hospital

Tehran, Iran

RECRUITING

Related Publications (3)

• Amini E, Keshteli AH, Jazi MS, Jahangiri P, Adibi P. Dyspepsia in Iran: SEPAHAN Systematic Review No. 3. Int J Prev Med. 2012 Mar;3(Suppl 1):S18-25.

  PMID: 22826763 RESULT

• Narendren A, Boddupalli S, Segal JP. British Society of Gastroenterology guidelines on the management of functional dyspepsia. Frontline Gastroenterol. 2023 Oct 11;15(1):70-73. doi: 10.1136/flgastro-2023-102508. eCollection 2024 Jan.

  PMID: 38487566 RESULT

• Batebi S, Masjedi Arani A, Jafari M, Sadeghi A, Saberi Isfeedvajani M, Davazdah Emami MH. Validity and Reliability of the Persian Version of Leeds Dyspepsia Questionnaire. Galen Med J. 2019 Dec 31;8:e1609. doi: 10.31661/gmj.v8i0.1609. eCollection 2019.

  PMID: 34466536 RESULT

Study Officials

• Raika Jamali, M.D.

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raika Jamali, Professor

CONTACT

+98-21-63120000; jamalira@tums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 6, 2025
• Study Start: April 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)