Clinical trial NCT06390787: The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics
Official title: Enhancing Antiemetic Efficacy: A Randomized Trial of Vitamin B6 and Metoclopramide Combination Therapy Versus Traditional Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vomiting
Keywords: Vomiting
B6 Vitamin
Metoclopramide
Zofran
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Any patients with vomiting

Exclusion Criteria:

* Patients vitally unstable

Primary outcomes:
measure: Nausea
timeFrame: 1 day
measure: Vomiting
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nasiriyah
country: Iraq
facility: Al-Nassiryah Teaching Hospital
state: Thi Qar
Study officials:
affiliation: University of Warith Al-Anbiyaa, College of Medicine
name: Hashim Talib T Hashim, MBChB
role: PRINCIPAL_INVESTIGATOR
References: