None listed
Conditions
Interventions
Intervention1: KaraShield: 500 mg, OD, Oral, 60 days
Control Intervention1: Placebo: 500 mg, OD, Oral, 60 days
Sponsors
Green Chem
Karallief Inc
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy male and female subjects between the age groups of 18â??60 years, who have a history of recurrent (at least 2 episodes and above in the last 2 months) upper respiratory tract infection (URI) and related symptoms such as common cold, cough, sore (scratchy) throat, nasal discharge (runny nose), nasal obstruction (plugged or congested), sneezing, headache, low-grade fever (malaise), tiredness/bodyache, chillness, etc. due to common cold and/ or seasonal change-related immunity disorders (except the allergic conditions) and/ or who have lower value of normal range for IgG at the time of study participation (baseline) (Normal range of IgG in adult: 600â??1600 mg/dL or, 6-16 g/L). • Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
Exclusion criteria
Exclusion criteria: • Subjects with the current habit or history of cigarette smoking. • Subjects with the current habit of alcohol consumption more than 2 standard drinks/ day. • Subjects with very high level of IgE • Subjects with the confirmed case of pneumonia or bronchitis. • Subjects with allergic rhinitis, sinusitis/ Pharyngitis or any other oropharyngeal disorder. • Subjects who underwent or need tonsillectomy or adenoidectomy. • Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc. • Subjects suffering from proteinuria (loss of protein in urine). • Subjects on any seizure medication. • Subjects on any other medication known to reduce IgG levels. • Subjects with a known history of any malignant disease. • Subjects with known history of autoimmune disease and other systemic diseases related to immune system. • Subjects with chronic immune diseases like HIV. • Subjects suffering with the infectious diseases HBsAg and HCV • Subjects treated with the following medications: a)Antibiotics less than one week before the study b)Any vaccination less than 4 weeks before the study c)Concomitant immunosuppressive or immune-stimulating therapy 3 months before the study start. • Subjects with concomitant treatment with corticosteroids. • Subjects who participated in another clinical trial less than 3 months prior to this study. • Subjects who are suffering from any communicable disease. • Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period. • Subjects with the history of consumption of any recreational drugs (such as cocaine, methamphetamine, marijuana, etc). • Subjects who are scheduled for any surgery within 3 months period of completing the study. • Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic • Subjects with inability or unwillingness to abide by the requirements of the protocol. • Subjects who are incompetent to sign an Informed Consent Form. • Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically confirmed episodes of Upper Respiratory Tract Infection (URI) related symptoms measured through Wisconsin Upper Respiratory Symptom Survey (WURSS-24) ScoreTimepoint: Day 0, Day 7, Day 15, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunity panel-CD3, CD4 & CD8 CountTimepoint: Day 0,Day 60;Immunity status Questionnaire (ISQ) ScoreTimepoint: Day 0, Day 7, Day 15, Day 30, Day 60;Immunoglobulin G (IgG) LevelTimepoint: Day 0,Day 60;Inflammatory Biomarker-C-Reactive Protein (CRP)Timepoint: Day 0,Day 60;Laboratory Safety ParametersTimepoint: Day 0,Day 60;Mean symptoms severity score of WURSS-24 ScoreTimepoint: Day 0, Day 7, Day 15, Day 30, Day 60;WHO-Quality of Life (WHOQOL-BREF)Timepoint: Day 0,Day 60 | — |
Countries
India
Contacts
Public ContactMr Dheeraj Kumar Deep
Green Chem
Outcome results
None listed