Completed

NCT Number: NCT02004197

Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

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.

Completed

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shifa Ul MUlk Memorial Hospital, Karachi, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Quadruple Allopathic therapy

Drug

Other names: Omeprazol, Amoxicillin, Metronodazole, TRITEC (ranitidine bismuth citrate)

Pylorex plus

Drug

Primary outcomes

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

Time frame: 1 month

Secondary outcomes

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

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Hafiz Muhammad Asif

Other

Registry information

Official study title

Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2013
First posted: Dec 9, 2013
Registry last updated: Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.