Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen

NCT03837210 | Completed Phase 2

• 1 other identifier: zahoor11
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common medical condition associated with gastritis1 more over peptic ulcer disease2, gastric adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of public health problem.5,6 rate of infection is abating in developed world 7 , but this is slow and people health is challenged, to stop or decrease the new cases is complicated despite the fact that route of transmission are still unclear .8-10 The only option for reducing incidence and prevalence is that screening of masses followed by eradication therapy. A rough estimate propose about 50% of developing country population is affected from infection than the industrialized country. Infected individual may be asymptomatic or some time present with gastroduodenal disease. Prevalence of H pylori is different in developing countries where the adult prevalence reaches up to 80% and in children it is found before the age of 10 years.

Conditions

H.Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication of H. Pylori

  Negative Stool antigen for H. pylori

  4 week duration

Study Arms (2)

Test Drug

EXPERIMENTAL

This group is treated with Herbal formulation.

Drug: Pylorin

Control Drug

ACTIVE COMPARATOR

This group is treated with Quintuple therapy

Drug: Pylorin

Interventions

Pylorin DRUG

Poly Herbal formulation

Also known as: Poly Herbal formulation

Control Drug; Test Drug

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The individuals suffering from H. pylori infection .
• Individuals having no previous history of H. pylori infection treatment.
• Individuals living in Karachi.
• Individuals with no pathological finding on routine examination.
• Individuals from either socioeconomic class including lower, middle and higher.
• Both male and female individuals between 14 to 55 years of age
• Subjects with informed written consent
• Patients having no complications regarding other than GIT system.

You may not qualify if:

• The following were the reason for excluding the individuals from this trial:
• Patient with simultaneous physical illness, for example renal dialysis and uncontrolled diabetes mellitus.
• Individuals having stomach or intestinal surgical history were excluded.
• Individuals with past record of any herbal or allopathic medication were excluded
• Individuals with hyper sensitivity history of drug or adverse reaction to any of the study drugs .
• Females with pregnancy were also excluded for the safety measures
• Individuals with coma, meningitis, and encephalitis or head injury were also excluded.
• Hospitalized individuals due to any serious diseases were excluded.
• Individuals with known poor compliance and history of drug abuse were excluded.

Sponsors & Collaborators

• Hamdard University: lead

Study Officials

• Zahoor Zaidi, M.Phil

  Hamdard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Syed Zahoor Ul Hassan Zaidi

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: January 5, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share