Post Marketing Observational Study to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo

Not Applicable

Completed

• Conditions: Disorder of brain, unspecified,

• Registration Number: CTRI/2022/01/039287
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

A Prospective, Multicenter, Open-Label, Single-Arm, Post Marketing Observational Study

to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo

Total 1708 patient will be recruited in the study in India. There will be total 5 Visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1708

Inclusion Criteria

• Patients of either sex in the age group of 18-65 years.
• Patients diagnosed with Meniere’s disease, vestibular neuritis, labyrinthitis, or post-operative vertigo.
• Patients willing to participate in the study and sign an informed consent form.

Exclusion Criteria

• Patients diagnosed with BPPV.
• Patients with history of psychiatric illness.
• Patients on anti-psychotic or anti-depressant medication.
• Patients with history of cardiovascular, kidney or liver disorder.
• Patients requiring hospitalization for any cause.
• Patients with suspected or established subcortical brain damage, with or without hypothalamic damage.
• Pregnant and nursing women.
• Women with childbearing potential who are not practicing a reliable method of birth control.
• Patients with a known history of hypersensitivity to phenothiazine derivatives.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing	Visit1 to Visit 5
clinical response based on the scale for vestibular vertigo severity level and clinical	Visit1 to Visit 5
response evaluation (SVVSLCRE), from baseline to post-treatment	Visit1 to Visit 5

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing	change in the severity of vertigo symptoms through improvement in nystagmus grading,

Trial Locations

Locations (28)

Bosco ENT Nursing and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

ACPM Medical College and Hospital; 🇮🇳 Dhule, MAHARASHTRA, India

Agrwal nursing home; 🇮🇳 Nagpur, MAHARASHTRA, India

AIIMS; 🇮🇳 Khordha, ORISSA, India

Anand ENT Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Dr. Sanika ENT Clinic; 🇮🇳 Nagpur, MAHARASHTRA, India

Dr. Shweta Gogia ENT Clinic; 🇮🇳 Delhi, DELHI, India

Excel Hopsital; 🇮🇳 Hyderabad, TELANGANA, India

Ghosh ENT Foundation; 🇮🇳 Kolkata, WEST BENGAL, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Scroll for more (18 remaining)

Bosco ENT Nursing and Research Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Carlton pereira

Principal investigator

919819643240

cdpereir@gmail.com