A multi-arm, open label, clinical study that will be conducted at one hospital to understand the safety and benefits of Aller GI health supplements in controlling sinusitis, rhinitis and skin allergy

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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063075

Enrollment

100

Registered

2024-02-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J019- Acute sinusitis, unspecified Health Condition 2: L239- Allergic contact dermatitis, unspecified cause Health Condition 3: J300- Vasomotor rhinitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age between 18 to 65 years. 2.Patients having symptoms of allergic rhinitis, sinusitis and skin allergy. 3.Scores from the global scale atopic dermatitis vIGA 4.Patients willing to comply by the study procedures and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with poorly controlled Hypertension or with uncontrolled Diabetes Mellitus and having a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: 1.Reduced symptoms of Sinusitis and Rhinitis (Fever if present is significantly improving, nasal discharge is lessening and reduced fatigue) 2.Assess the improvement in Skin Allergy Timepoint: 1.Day 1,15,30,45 and 60	—

Secondary

Measure	Time frame
1.Assessment of adverse events during the treatment phase (percentage & treatment discontinuation rates due to AEs will be assessed)Timepoint: Day 15,30,45,60	—

Countries

India

Contacts

Public ContactMs Satyavathi LM

LIFE AVEDA

vijaykimtata.vk@gmail.com9816333352

Outcome results