None listed
Conditions
Interventions
Intervention1: Nutraceutical-1,2,3: 2 tablets twice daily to be
consumed orally for 30 days:
Botanical formulation of extracts
from Adulsa, Turmeric, Tulsi, and glycyrrhiza glabra
Control Intervention
Sponsors
Amway India Enterprises Pvt Ltd
Siro Clinpharm Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, 18-60 years of age; 2. Subject should have respiratory symptoms score >=10, as assessed by Part 1 of SGRQ; 3. Subject has FEV1 >=70% of predicted; 4. Subject is currently not consuming any medication for respiratory symptoms or respiratory impairment; 5. Subject has been residing in a highly polluted urban area (AQI >100) without interruption since at least 6 months; Interruption defined as the subject being away from highly polluted urban area for more than 2 weeks in the last 6 months; 6. Subject is literate and can read/write; 7. Subject should be willing to maintain habitual diet and physical activity patterns during the study period; 8. Female subjects of childbearing potential should have a negative serum pregnancy test (human chorionic gonadotropin, beta subunit [β-hCG]) at screening; 9. Male and female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study. Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care; 10. Subject has laboratory investigations within normal reference range. If abnormal laboratory values, they should be deemed as not clinically significant by principal investigator for hematology and biochemistry; Note: If the subject is included in the study as per investigator discretion based on abnormal non-clinically significant laboratory values, the details of subject inclusion will be recorded in CRF; 11. Subject tests negative for hepatitis B surface antigen (HbsAg), antihepatitis C virus antibodies, and anti-HIV antibodies at screening; 12. Subject is willing to provide written informed consent; 13. Subject is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1. Subject has known allergies to the herbal products or allergy to any of the components of the study product; 2. Subject has a history or presence of clinically important respiratory disease (including but not limited to uncontrolled asthma, chronic obstructive pulmonary disease, and restrictive lung disease) or such disease is detected at the time of screening and requires active treatment.(Note: Subjects with mild obstructive respiratory diseases requiring treatment only on â??as neededâ?? basis can be included in the study. Such subjects will have to undergo a washout period of 6-8 hours prior to spirometry evaluation at all visits, including screening visit). 3. Subject has current or past history of smoking; 4. Subject has difficulty swallowing tablets that could affect ability to consume the study product; 5. Subject has hemoglobin level of 6. Subject had an upper or lower respiratory tract infection within 2 weeks prior to screening; 7. Subject with history of use of medications known to affect respiratory function (e.g. bronchodilators, anti-histaminics, theophyllines, leukotriene antagonists, mast-cell stabilizers, benztropine, inhaled/systemic corticosteroids, beta-blockers, angiotensin converting enzyme inhibitors, opioids etc) or any other medications in the opinion of investigator that may interfere with study outcomes, in the past 1 month. 8. Subjects with a history of use of other herbal or nutritional supplements including multivitamin/multi-mineral supplements that modify pulmonary function in the past 6 months and is unwilling to refrain from their use through the duration of the trial; 9. Subject with history of significant renal, hepatic, cardiovascular, hematologic, metabolic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, neurologic, endocrine dysfunction, malignancy (except basal cell carcinoma), or any other significant medical illness or disorder which, in the judgment of the investigator could interfere with the study or require treatment(s) which might interfere with study or which may pose risk to the patient; 10. History of drug abuse or alcohol consumption in the past 12 months. Note: If the subject is a social drinker (i.e. 11. History of participation in any other clinical study within last 60 days; 12. Subject is pregnant or breast-feeding at the time of screening, or planning to be pregnant during the study; 13. Any other condition that in the investigatorâ??s judgment, might interfere with study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints The assessment of safety will be based on number of subjects reporting any AE, any serious AE(SAE), any study product-related AE, any study product-related SAE, and discontinuations due to AE. Efficacy Endpoints: To compare the change from baseline in pulmonary function, oxidative stress markers, gene expression profile, respiratory symptoms severity score based on VAS and QOLs and 6-minute walk test, after 30 days of consumption of study products. Timepoint: Safety Endpoints will be assessed at all the visits from baseline to end of study Efficacy endpoints will be assessed after 7 days and after 30 days of consumption of study products | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMr Partha Chatterjee
Head Clinical Research and CTSM
Outcome results
None listed