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

• ClinicalTrials.gov Identifier: NCT03837210
• Recruitment Status: Completed
• First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Sponsor: Hamdard University
• Information provided by (Responsible Party): Syed Zahoor Ul Hassan Zaidi, Hamdard University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
H.Pylori Infection	Drug: Pylorin	Phase 2; Phase 3

Detailed Description:

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.

Aims and objectives

1. To establish and evaluate scientific and clinical evidence of herbal/eastern formulation and find out the clinical safety and efficacy.
2. To measure the clinical response of herbal formulation in the patients of H.Pylori.

Research Questions

1. has the Unani formulation better effects than quadruple regimen?

Hypothesis (H1): Unani has shown better clinical, effects than quadruple regimen.

Null Hypothesis (Ho): Quadruple regimen has shown superior clinical, response than Unani formulation.

Experimental approaches

To check this hypothesis independent variable to dependent variable and perplexing variables will apply by statistical analysis. In this study H. Pylori infection, quadruple regimen are independent variables while signs and symptoms, level of improvement are dependent variables.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen
• Actual Study Start Date: January 5, 2017
• Actual Primary Completion Date: January 10, 2019
• Actual Study Completion Date: January 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test Drug; This group is treated with Herbal formulation.	Drug: Pylorin; Poly Herbal formulation; Other Name: Poly Herbal formulation
Active Comparator: Control Drug; This group is treated with Quintuple therapy	Drug: Pylorin; Poly Herbal formulation; Other Name: Poly Herbal formulation

Outcome Measures

Primary Outcome Measures :

1. Eradication of H. Pylori [ Time Frame: 4 week duration ]
   Negative Stool antigen for H. pylori

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria

The following were the reason for excluding the individuals from this trial:

1. Patient with simultaneous physical illness, for example renal dialysis and uncontrolled diabetes mellitus.
2. Individuals having stomach or intestinal surgical history were excluded.
3. Individuals with past record of any herbal or allopathic medication were excluded
4. Individuals with hyper sensitivity history of drug or adverse reaction to any of the study drugs .
5. Females with pregnancy were also excluded for the safety measures
6. Individuals with coma, meningitis, and encephalitis or head injury were also excluded.
7. Hospitalized individuals due to any serious diseases were excluded.
8. Individuals with known poor compliance and history of drug abuse were excluded.

Contacts and Locations

Sponsors and Collaborators

Hamdard University

Investigators

• Principal Investigator: Zahoor Zaidi, M.Phil; Hamdard University

More Information

• Responsible Party: Syed Zahoor Ul Hassan Zaidi, Hamdard University
• ClinicalTrials.gov Identifier: NCT03837210
• Other Study ID Numbers: zahoor11
• First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No