Study of KaraShield-a herbal formulation towards the enhancement of immunity in healthy population.
- Registration Number
- CTRI/2022/06/043331
- Lead Sponsor
- Green Chem
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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 <700 KU/L (allergic patient)
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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