Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

Sponsor

Hafiz Muhammad Asif (Other)

Overall Status

Completed

CT.gov ID

NCT02004197

Collaborator

(none)

176

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori [H. Pylori] as the Cause of Diseases	Drug: Quadruple Allopathic therapy Drug: Pylorex plus	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pylorex plus Pylorex plus consisting of medicinal plants.	Drug: Quadruple Allopathic therapy Other Names: Omeprazol Amoxicillin Metronodazole TRITEC (ranitidine bismuth citrate) Drug: Pylorex plus
Active Comparator: Quadruple therapy Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)	Drug: Quadruple Allopathic therapy Other Names: Omeprazol Amoxicillin Metronodazole TRITEC (ranitidine bismuth citrate) Drug: Pylorex plus

Arm

Intervention/Treatment

Experimental: Pylorex plus

Pylorex plus consisting of medicinal plants.

Drug: Quadruple Allopathic therapy

Other Names:

Omeprazol

Amoxicillin

Metronodazole

TRITEC (ranitidine bismuth citrate)

Drug: Pylorex plus

Active Comparator: Quadruple therapy

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

Drug: Quadruple Allopathic therapy

Other Names:

Omeprazol

Amoxicillin

Metronodazole

TRITEC (ranitidine bismuth citrate)

Drug: Pylorex plus

Outcome Measures

Primary Outcome Measures

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

The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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
2	Shifa Ul MUlk Memorial Hospital	Karachi		Pakistan