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Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

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ClinicalTrials.gov Identifier: NCT02004197
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004197


Locations
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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
Shifa Ul MUlk Memorial Hospital
Karachi, Pakistan
Sponsors and Collaborators
Hafiz Muhammad Asif
Investigators
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Study Director: Khan Usman Ghani, Ph. D Hamdard University Karachi

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Responsible Party: Hafiz Muhammad Asif, Doctor, Shifa Ul Mulk Memorial Hospital
ClinicalTrials.gov Identifier: NCT02004197     History of Changes
Other Study ID Numbers: Asif-HP-001
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Amoxicillin
Bismuth tripotassium dicitrate
Bismuth
Ranitidine
Ranitidine bismuth citrate
Anti-Bacterial Agents
Anti-Infective Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anti-Ulcer Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs