Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304532
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-03-05
Brief Title:
Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H Pylori Infection
Sponsor:
Hamdard University
Organization:
Hamdard University
Study Overview
Official Title:
Clinical Efficacy Assessment of Alsareen Capsule for the Management of Helicobacter Pylori H Pylori Infection
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 44 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
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
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 15 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 44 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
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 15 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 44 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None