None listed
Conditions
Interventions
Intervention1: GH-LS-R1 (Mucilage Rich Supplement): Dietary Supplement for improvement in lungs functioning
Control Intervention1: Mycrocrytalline Cellulose: Placebo
Sponsors
Verisearch Lab
BioAxion Innovations
Eligibility
Inclusion criteria
Inclusion criteria: Individuals working outdoors for more than equal to 2 years with at least 8 hours of working time in pollution heavy area. Systolic blood pressure less than equal to 140. Diastolic blood pressure less than equal to 90. Individuals with complains of one or more of the listed respiratory problems which includes cough, breathlessness, fatigue and/or sneezing due to exposure to pollution, at least once every 2 weeks. Individuals with FEV1 by FVC ratio greater than equal to 0.5 and less than equal to 0.7. Individuals with the ability to read and provide written, personally signed, and dated informed consent to participate in the study. RBC count Less than normal (Normal Value Male 4.5 to 6.5 mil by cmm; Female 4 to 5.4 mil by cmm)
Exclusion criteria
Exclusion criteria: Individuals with FEV1 by FVC ratio less than 0.5. History of gastroenteritis in the past month Usage of hormones and steroids in 60 days before entering the study. Usage of antibiotics in 15 days before entering the study. Usage of nasal spray or other probiotics (such as lactic acid bacteria, Bifidobacterium) in the last one month. Lymph node enlargement, inflammation, polyps, mass, runny nose, etc., after clinical examination of lips, throat, ears, nostrils, and neck Clinically significant GI condition (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose and gluten intolerance or allergies). Recent (within 2 weeks of screening) history of an episode of acute GI illness such as nausea/vomiting or diarrhoea (defined as greater than equal to 3 loose or liquid stools/day) Individuals with history of gastrointestinal surgery Long history of drug use Individuals with history of smoking in the past 5 years or currently smoking or using any form of tobacco. Post-menopausal women Pregnant and/ or lactating females Inability to understand and cooperate with the study process. Participated in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the lung s capacity as indicated by higher increase in the Tiffeneau-Pinelli index (FEV1/FVC ratio) from baseline to EOS, as compared to placebo. Timepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
BioAxion Innovations
Outcome results
None listed