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

NCT ID: NCT06390787

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2024-04-21

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.

Conditions

Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metoclopramide Group

This group of 50 patients with vomiting were given Metoclopramide only for vomiting.

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

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

Zofran Group

This group of 50 patients with vomiting were given Zofran only for vomiting.

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

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

B6 and Metoclopramide Group

This group of 50 patients with vomiting were given B6 and Metoclopramide combination for vomiting.

Group Type: EXPERIMENTAL

Metoclopramide and Vitamin B6

Intervention Type: DRUG

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

Control Group

This group of 50 patients with vomiting were given nothing for vomiting.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vitamin B6 Group

This group of 50 patients with vomiting were given Vitamin B6 only for vomiting.

Group Type: ACTIVE_COMPARATOR

Vitamin B6

Intervention Type: DRUG

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

Interventions

Metoclopramide and Vitamin B6

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

Intervention Type: DRUG

Vitamin B6

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

Intervention Type: DRUG

Ondansetron

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

Intervention Type: DRUG

Metoclopramide

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

Intervention Type: DRUG

Other Intervention Names

Vitamin B6 and Metoclopramide combination; Pyridoxine; Zofran; Plasil

Eligibility Criteria

Inclusion Criteria

• Any patients with vomiting

Exclusion Criteria

• Patients vitally unstable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Hashim Talib Hashim

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hashim Talib T Hashim, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Warith Al-Anbiyaa, College of Medicine

Locations

Al-Nassiryah Teaching Hospital

Nasiriyah, Thi Qar, Iraq

Countries

Iraq

Other Identifiers

007

Identifier Type: -

Identifier Source: org_study_id