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NCT Number: NCT06390787

The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics

This study investigates the effectiveness of combining vitamin B6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. Through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the frequency, severity, and tolerability of the B6 and metoclopramide combination. By elucidating its comparative efficacy against established antiemetics, this research seeks to provide evidence-based guidance for clinicians in selecting optimal treatment regimens tailored to individual patient needs, ultimately enhancing the management of nausea and vomiting across various medical conditions.

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Key information

Conditions

Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Al-Nassiryah Teaching Hospital

Nasiriyah, Thi Qar, 64001, Iraq

About this study

Title: Investigating the Efficacy of B6 and Metoclopramide Combination Versus Alternative Antiemetics: A Clinical Trial Proposal

Introduction:

Nausea and vomiting are common symptoms across various medical conditions and can significantly impact patients' quality of life and treatment outcomes. While several antiemetic medications exist, finding the most effective regimen remains a clinical challenge. This proposal aims to investigate the efficacy of a combination therapy comprising vitamin B6 (pyridoxine) and metoclopramide compared to other antiemetics in managing nausea and vomiting.

Rationale:

Both vitamin B6 and metoclopramide have shown antiemetic properties through different mechanisms of action. However, the comparative efficacy of this combination therapy against other standard antiemetics remains largely unexplored. Understanding the relative effectiveness of this combination could provide valuable insights into optimizing antiemetic strategies, particularly in patients with chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other related conditions.

Objectives:

This prospective, randomized controlled trial aims to evaluate the efficacy of B6 and metoclopramide combination therapy compared to alternative antiemetic regimens in reducing the frequency and severity of nausea and vomiting episodes in adult patients. Additionally, the study seeks to assess the safety profile and tolerability of the combination therapy.

Conclusion:

By elucidating the comparative efficacy of B6 and metoclopramide combination therapy, this study endeavors to contribute to evidence-based decision-making in the management of nausea and vomiting. The findings could potentially guide clinicians in selecting the most appropriate antiemetic regimen tailored to individual patient needs, ultimately improving patient outcomes and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patients with vomiting

Exclusion criteria

  • Patients vitally unstable

Treatment and study plan

Metoclopramide and Vitamin B6

Drug

We gave a combination of vitamin B6 (pyridoxine) and metoclopramide as a treatment for managing nausea and vomiting.

Other names: Vitamin B6 and Metoclopramide combination

Vitamin B6

Drug

We gave only vitamin B6 (pyridoxine) as a treatment for managing nausea and vomiting.

Other names: Pyridoxine

ondansetron

Drug

We gave only Zofran as a treatment for managing nausea and vomiting.

Other names: Zofran

Metoclopramide

Drug

We gave only Metoclopramide as a treatment for managing nausea and vomiting.

Other names: Plasil

Primary outcomes

  1. Nausea

    Time frame: 1 day

    Four characteristics of nausea typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced nausea and/or the number of hours that nausea was experienced during the time frame addressed.

  2. Vomiting

    Time frame: 1 day

    Four characteristics of vomiting typically were measured including duration, frequency, severity, and associated distress. Duration was measured by asking the patient if they had experienced vomiting and/or the number of hours that vomiing was experienced during the time frame addressed.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Enhancing Antiemetic Efficacy: A Randomized Trial of Vitamin B6 and Metoclopramide Combination Therapy Versus Traditional Regimens

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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