Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection

March 11, 2024 updated by: Anees ur Rehman, Hamdard University

Clinical Efficacy Assessment of Alsareen Capsule for the Management of Helicobacter Pylori (H. Pylori) Infection

Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (<20 years) group. In young age (20-40) and old age (>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.

In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects & a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Introduction:

Peptic ulcers are open sores that develop on the inside lining of stomach and the upper portion of small intestine. The most common symptom of a peptic ulcer is stomach pain. Peptic ulcers include; Gastric ulcers that occur on the inside of the stomach and Duodenal ulcers that occur on the inside of the upper portion of small intestine (duodenum). The most common cause of peptic ulcers infection is the bacterium Helicobacter pylori (H. pylori). Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. The World Health Organization has declared H. pylori as a Class 1 carcinogen.

In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects & a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy.

Alsareen is a DRAP registered product of Hamdard Laboratories (Waqf) Pakistan (HLWP). Alsareen is a time tested formulation developed at Hamdard Research Center and it is being used clinically for more than 15 years. This formulation was shared for broader use at Hamdard Matabs since 1.5 years and found satisfactory. The study will be conducted at Shifa ul Mulk Memorial Hospital Hamdard University, Hamdard Matab Nazimabad and Hamdard Matab Arambagh. The sample size of 50 Subjects suffering from H. pylori Infection will be study and managed by Unani Medicine 'Alsareen'.

Epidemiology:

H. pylori prevalence ranges between 85% and 95% in developing countries and between 30 and 50% in developed countries. After the year 2000, the prevalence of H. pylori became lower than before in European countries. However, in Asia, the prevalence remains the same. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (<20 years) group. In young age (20-40) and old age (>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively. Typically, around 90% of infected individuals do not have clinical indications or complications of the illness. However, untreated H. pylori infection can last a lifetime leading to chronic gastritis, which can develop into ulcer and carcinoma. This introduces the need for early diagnosis and proper disease therapy.

Clinical presentation:

The combination of retrosternal pain, weight loss, food intolerance and the absence of halitosis signified a 64% accuracy in predicting H. pylori infection. It is not possible to differentiate between H. pylori-positive and H. pylori-negative functional dyspeptics on the basis of clinical presentation and the number of complaints. However, overall symptom score and severity of several symptoms was significantly higher in the H. pylori-positive group.

Study objective:

To conduct an open randomized, multicenter pilot study for the evaluation of clinical efficacy of Alsareen capsule for the management of H pylori infection.

Null hypothesis (H0) There are no significant effects of Unani Medicine 'Alsareen' in the management of H pylori infection.

Alternate hypothesis (H1) Unani medicine 'Alsareen' is clinically effective for the Management of H pylori Infection.

Study Design:

Open label, single arm pilot study. Duration of treatment: 6 weeks of treatment followed by 2 weeks of washing period.

Subjects with clinical presentation of H pylori infection.

Labs Investigations:

Screening Marker:

Blood Anti H pylori

Diagnostic Marker:

Stool Ag for H pylori

Safety Profile:

CBC & ESR LFTs Serum Urea Serum Creatinine These tests will be done in the pathological laboratory of Dow Lab. The subjects meeting the eligibility criteria will be enrolled after taking written informed consent for the study trial. Unani medicine Alsareen will be prescribed to the subjects meeting the selection criteria. The follow ups will be after every two weeks till the end of treatment followed by two weeks washing period.

Subject selection Inclusion criteria Subjects suffering from H. pylori Infection. Subjects having positive test for stool Ag of H. pylori. Subjects over 15 years of age. Subjects agree to use Test Drug throughout the study. Subjects of both sexes are involved. Non pregnant & Non lactating mother. Exclusion criteria Subjects suffering from chronic liver diseases and kidney failure. Subjects currently taking any antibiotics. Subjects suffering from any type of cancer and any other comorbid condition. Subjects having history of adverse drug reaction.

Study Centers:

This study will be conducted in these clinical settings;

1. Shifa ul Mulk Memorial Hospital Hamdard University

Sample Size:

n= 50 subjects.

Study Medicine Details:

Description:

Alsareen is a DRAP registered product of Hamdard Laboratories (Waqf) Pakistan (HLWP) whose ingredients are:

  1. Pistacia lentiscus
  2. Carum carvi
  3. Curcuma caesia

Dosage & Treatment Regimen:

Study medicine dose is 450mg capsule twice daily. Orally before meal with plain water.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Shifa Ul Memorial Hospital-Hamdard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consisted of individuals residing in Karachi, specifically focusing on those living near Hamdard University,Gadap Town, a peri-urban area known for its diverse socio-economic and demographic profile. Participants were selected from various neighborhoods to ensure representation across different socio-economic strata.

Description

Inclusion Criteria:

  • Subjects suffering from H. pylori Infection.
  • Subjects having positive test for stool Ag of H. pylori.
  • Subjects over 15 years of age.
  • Subjects agree to use Test Drug throughout the study.
  • Subjects of both sexes are involved.

Exclusion Criteria:

  • Subjects suffering from chronic liver diseases and kidney failure.
  • Subjects currently taking any antibiotics.
  • Subjects suffering from any type of cancer and any other comorbid condition.
  • Subjects having history of adverse drug reaction.
  • Pregnant & lactating mother.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
H. pylori stool for antigen test will screened before and after treatment.
Time Frame: 42 days
after administering medication, the H. pylori stool antigen test yielded a negative result, indicating the absence of H. pylori antigens in the stool sample.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamdard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Syed Zahoor Zaidi, Hamdard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HU123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on H. Pylori Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings