Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

Phase 2

Completed

• Conditions: Helicobacter Pylori [H. Pylori] as the Cause of Diseases
• Interventions: Drug: Quadruple Allopathic therapy; Drug: Pylorex plus

• Registration Number: NCT02004197
• Lead Sponsor: Hafiz Muhammad Asif

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Study First Submitted: 2013-08-20
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-05
• Last Update Submitted: 2013-12-05
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pylorex plus	Quadruple Allopathic therapy	Pylorex plus consisting of medicinal plants.
Pylorex plus	Pylorex plus	Pylorex plus consisting of medicinal plants.
Quadruple therapy	Quadruple Allopathic therapy	Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
Quadruple therapy	Pylorex plus	Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores	1 month

Trial Locations

Locations (2)

Shifa Ul MUlk Memorial Hospital; 🇵🇰 Karachi, Pakistan

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