Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Capsule containing Beta-glucan, Elderberry and Acerola extracts, Ascorbic acid & zinc combination: Each capsule contains:
Betaglucan (wellmune) - 50mg
Elderberry extract - 30
Sponsors
MrSivaraj Solistaa Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily. 3. Have at least 2 of the following 7 URI symptoms (nasal congestion, sore throat, cough, aches and pains, fatigue, headaches, and chills or sweats) graded as either moderate or severe 4. Have access to a mobile phone for follow up. 5. Have been prescribed or offered a prescription for antibiotics or anti histamines or anti pyretics for URI treatment.
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period. 2. Known allergy to elderberry extract or Betaglucan or other compounds of investigational product. 3. Presence of any co morbid conditions like diabetes mellitus, coronary artery disease, CNS, Liver and any Renal pathological conditions 4. Patients with cystic fibrosis, any known cases of tuberculosis or other morbid lung pathologies. 5. Immuno-compromised individuals like known HIV positive patients or patients who are on treatment with steroids or immunomodulators. 6. Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged). 7. Participation in any clinical trial in the past 1 month. 8. History of drug or alcohol abuse during the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be time to alleviation of all symptoms. Seven symptoms (Nasal congestion, Sore throat, Cough, Aches and Pains, Fatigue, Headaches, and Chills or Sweats)" will be graded by severity as "Absent" (0), "Mild" (1), "Moderate" (2), or "Severe" (3). Alleviation will be defined to arise when all symptoms scored as absent or mild, and remain so for at least 21.5 hoursTimepoint: Day 1-7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any Adverse events during the study period and assess the Quality of life using a Pre-and Post-feedback Questionnaire.Timepoint: Day 1-7 | — |
Countries
India
Contacts
Public ContactRamesh Kannan
KI3, CRO
Outcome results
None listed