A prospective, multi-arm, open label, single center clinical study to evaluate the safety and efficacy of Aller GI health supplements in controlling sinusitis, rhinitis and skin allergy

The research, titled " A Prospective, Multi-Arm, Open-Label, Single-Centre Clinical Study," seeks to explore the impact of ALLER GI Health Supplements on sinusitis, rhinitis, and skin allergy symptoms.

The study to be conducted at a single center, aims to enroll 100 evaluable patients experiencing sinusitis, rhinitis, and skin allergy. This open-label, two-arm study categorizes subjects based on their indications without formal statistical assessment.

In the study therapy, each patient is recommended to consume two capsules twice daily for a duration of 60 days.

This open-label study categorizes subjects into two arms based on their indications, with Arm A including subjects diagnosed with sinusitis and rhinitis, and Arm B comprising subjects with skin allergy.

The randomization of subjects into arms is based on the indication without formal statistical assessment.

The study’s objectives involve assessing the effectiveness of the test product in mitigating symptoms associated with sinusitis and rhinitis, as well as evaluating its efficacy in alleviating skin rashes and allergic reactions.

Inclusion criteria include participants aged between 18 to 65 years with presenting symptoms of allergic rhinitis, sinusitis, and positive scores on the global scale for atopic dermatitis vIGA. Participants must also express willingness to comply with study procedures and sign an informed consent form.

Exclusion criteria excludes the patients with poorly controlled hypertension or uncontrolled diabetes mellitus, coupled with a history of atrial fibrillation, acute coronary syndrome, myocardial infarction, stroke, or severe arrhythmia within the last 6 months.

Safety endpoints encompass the percentage of adverse events and treatment discontinuation rates, including early discontinuation and discontinuation due to adverse events.

Primary endpoints include the time required to alleviate symptoms of rhinitis, sinusitis, and skin allergy. Additionally, a reduction in CGAS score serves as a measure of overall clinical improvement, while a decrease in the secondary vIGA score assesses global severity improvement specifically related to targeted symptoms.

Secondary endpoints focus on the incidence of nasal or skin irritation and any adverse events during the treatment phase.

Outcome Measures

Primary Outcome Measures (AllerGI Capsules (n=100))

1. Reduction in Sinusitis Symptoms 93%

2. Reduction in Rhinitis Symptoms 94%

3. Reduction in Skin Allergy Symptoms 89%

Secondary Outcome Measures (AllerGI Capsules (n=100))

1. Adverse Reactions 0%

2. Safety Profile The study drug was well tolerated.

**Adverse Events and Serious Adverse Events:**There were no SAE or AE reported in this study.