Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06304532 |
| Other study ID # |
HU123 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2023 |
| Est. completion date |
March 6, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Hamdard University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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.
