Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

NCT02004197 | Completed Phase 2 DMC

• 1 other identifier: Asif-HP-001
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief Summary

Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.

Conditions

Helicobacter Pylori [H. Pylori] as the Cause of Diseases

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment

  1 month

Secondary Outcomes (1)

• The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores

  1 month

Study Arms (2)

Pylorex plus

EXPERIMENTAL

Pylorex plus consisting of medicinal plants.

Drug: Quadruple Allopathic therapy; Drug: Pylorex plus

Quadruple therapy

ACTIVE COMPARATOR

Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)

Drug: Quadruple Allopathic therapy; Drug: Pylorex plus

Interventions

Quadruple Allopathic therapy DRUG

Also known as: Omeprazol, Amoxicillin, Metronodazole, TRITEC (ranitidine bismuth citrate)

Pylorex plus; Quadruple therapy

Pylorex plus DRUG

Pylorex plus; Quadruple therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patients suffering from H. pylori infection
• Patients having no previous record of treatment against H. pylori infection
• Patients living in Karachi, Rawalpindi and Bahawalpur
• Patients having no pathological complications on routine examination
• All socioeconomic classes were included in the study
• Male and female patients between 15 to 45 years of age

You may not qualify if:

• there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
• if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
• any patient found to be allergic or intolerant to therapeutic regimens
• they failed to report for follow-up

Sponsors & Collaborators

• Hafiz Muhammad Asif: lead

Study Sites (2)

clinical trial was conducted in high risk areas of Pakistan such as Karachi, Bahawalpur, Islamabad and Rawalpindi at Shifa-Ul-Mulk Memorial Hospital, Hamdrad University Karachi, Bahawalpur Victoria Hospital and Nawaz Salik Hospital respectively

Karachi, Pakistan

Location

Shifa Ul MUlk Memorial Hospital

Karachi, Pakistan

Location

MeSH Terms

Interventions

Omeprazole; Amoxicillin; ranitidine bismuth citrate

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Khan Usman Ghani, Ph. D

  Hamdard University Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

PA (2)