A clinical study to assess if Sairub Heal and Immunocare drops products are safe and work effectively in individuals with respiratory viral infections

A Single-Center, Open-Label, Clinical Study to evaluate the safety and efficacy of Sairub Heal and Immunocare drops for the treatment of respiratory viral infections - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093648

Enrollment

Registered

2025-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: J069- Acute upper respiratory infection,unspecified Health Condition 2: J111- Influenza due to unidentified influenza virus with other respiratory manifestations Health Condition 3: J129- Viral pneumonia, unspecified Health Condition 4: J209- Acute bronchitis, unspecified Health Condition 5: J22- Unspecified acute lower respiratory infection

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged 18 to 70 years. 2.Clinical diagnosis of respiratory viral infection including: a.Recent onset less than or equal to 2 days of bronchial mucus production with impaired cough. b.Presence of respiratory symptoms for example - runny nose, cough, throat irritation or tickling. c.Presence of systemic symptoms for example - weakness, myalgia, headache, chills, sweating. d.Symptoms such as fever, productive cough, dyspnea, or chest pain with oxygen saturation SpO2 greater than or equal to 94 percent on room air. e.Symptom frequency of more than once a week but less than once a day for example- wheeze, cough, breathlessness. 3.FEV1 greater than or equal to 60 percent predicted at screening. 4.Reversible airway obstruction confirmed by greater than or equal to 12 percent improvement in FEV1 post bronchodilator. 5.Ability and willingness to comply with study procedures and visit schedule. 6.Willingness to abstain from other respiratory treatments during the study, unless medically necessary. 7.Written informed consent obtained prior to any study related procedure.

Exclusion criteria

Exclusion criteria: 1.Requirement for antiviral medications during the study period. 2.Known primary or secondary immunodeficiency for example- HIV, immunosuppressive therapy. 3.History or suspicion of malignancy except benign neoplasms. 4.Active tuberculosis or other concurrent infections requiring antibiotic therapy. 5.Presence of aggravated or decompensated chronic disease that could interfere with study compliance. 6.Diagnosed malabsorption syndromes, including lactase or disaccharidase deficiency, galactosemia. 7.Known allergy or hypersensitivity to any components of Sairub Heal or Immunocare Drops. 8.Pregnancy or breastfeeding;recent childbirth within 3 months prior to enrollment. 9.Unwillingness or inability to use acceptable contraceptive methods during the study period. 10.Participation in another interventional clinical trial within the last 30 days.

Design outcomes

Primary

Measure	Time frame
1.Change in Forced Expiratory Volume in 1 Second (FEV1). 2.Change in Peak Expiratory Flow Rate (PEFR). 3.Change in Oxygen Saturation (SpO2). 4.PCR-confirmed incidence of respiratory viral infection.Timepoint: Day 0, Day7 , Day 14	—

Secondary

Measure	Time frame
1.Change in Serum Immunoglobulin G (IgG) levels. 2.Patient Global Impression of Change (PGIC). 3.Incidence and severity of Adverse Events (AEs). 4.Changes in vital signs. 5.Physical examination findings.Timepoint: Day 0, Day 7, Day 14	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results