Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection

NCT06304532 | Completed DMC

• 1 other identifier: HU123
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively. In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori stool for antigen test will screened before and after treatment.

  after administering medication, the H. pylori stool antigen test yielded a negative result, indicating the absence of H. pylori antigens in the stool sample.

  42 days

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consisted of individuals residing in Karachi, specifically focusing on those living near Hamdard University,Gadap Town, a peri-urban area known for its diverse socio-economic and demographic profile. Participants were selected from various neighborhoods to ensure representation across different socio-economic strata.

You may qualify if:

• Subjects suffering from H. pylori Infection.
• Subjects having positive test for stool Ag of H. pylori.
• Subjects over 15 years of age.
• Subjects agree to use Test Drug throughout the study.
• Subjects of both sexes are involved.

You may not qualify if:

• Subjects suffering from chronic liver diseases and kidney failure.
• Subjects currently taking any antibiotics.
• Subjects suffering from any type of cancer and any other comorbid condition.
• Subjects having history of adverse drug reaction.
• Pregnant \& lactating mother.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Shifa Ul Memorial Hospital-Hamdard University

Karachi, Sindh, Pakistan

Location

Study Officials

• Syed Zahoor Zaidi

  Hamdard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: August 15, 2023
• Primary Completion: March 5, 2024
• Study Completion: March 6, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)