Health Condition 1: J989- Respiratory disorder, unspecified
Conditions
Interventions
None listed
Sponsors
Sahyadri Ayurvedic Life Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be eligible to participate if they meet all of the following criteria: 1. Adults of either gender, aged 21 to 70 years at the time of enrollment. 2. Participants with habitual snoring, as reported by the participant or bed partner. 3. Presence of a bed partner who is able to provide feedback. 4. Participants identified as at risk of snoring or sleep-disordered breathing based on screening using the Berlin Questionnaire (BQ). 5. Participants who are willing to avoid the use of other anti-snoring treatments or devices (e.g., nasal strips, oral appliances, throat sprays, or medications intended for snoring relief) during the study period. 6. Participants who are willing and able to provide written informed consent. 7. Participants who are willing to comply with the study requirements, including completing all scheduled visits and questionnaires.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria: 1. Diagnosed moderate to severe obstructive sleep apnea (OSA) or currently receiving treatment such as continuous positive airway pressure (CPAP) therapy. 2. Presence of significant nasal obstruction, severe deviated nasal septum, chronic sinusitis, or other structural airway abnormalities that may contribute to snoring. 3. Acute respiratory tract infection, throat infection, or active upper airway inflammation at the time of screening. 4. History of chronic respiratory disorders, including uncontrolled asthma or chronic obstructive pulmonary disease (COPD). 5. Known hypersensitivity or allergy to any ingredient of the investigational product. 6. Current smokers or individuals with history of excessive alcohol consumption, which may significantly influence snoring severity. 7. Pregnant or lactating women. 8. Participation in another clinical trial within 30 days prior to screening. 9. History of drug or alcohol abuse or dependence within the past 5 years. 10. Any clinically significant medical or psychiatric condition that, in the Investigator s opinion, may interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Snoring Symptoms: a. Change in Berlin Questionnaire (BQ) score from Baseline (Day 0) to End of Treatment (Day 30), with interim assessment at Day 15. b. Assesses improvement in snoring-related symptoms and risk of sleep-disordered breathing, including domains related to snoring frequency, daytime sleepiness, and hypertension-related risk factors. Timepoint: Day 0- Visit 1 Day 15 2 days- Visit 2 Day 30 2 days- Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Snoring Severity & Snoring-Related Quality of Life: a. Change in Snore Outcome Survey (SOS) total score from Baseline (Day 0) to Day 15 & Day 30. b. Evaluates improvement in snoring-related symptoms & their impact on sleep quality, daytime functioning, & social interactions. Timepoint: Day 0- Visit 1 Day 15 2 days- Visit 2 Day 30 2 days- Visit 3;2. Change in Snore Outcome Survey Domain Scores: a. Change in individual domain scores of the Snore Outcome Survey (SOS) from Baseline to Day 15 & Day 30. b. Assesses improvement in participant-reported outcomes related to sleep disturbance, daytime fatigue, & social impact of snoring Timepoint: Day 0- Visit 1 Day 15 2 days- Visit 2 Day 30 2 days- Visit 3;3. Safety & Tolerability a. Incidence, type, severity, & causality of Adverse Events (AEs) reported throughout the study period. b. Any Serious Adverse Events (SAEs) reported during the study. c. Changes in vital signs (including systolic blood pressure, diastolic blood pressure, pulse rate, & respiratory rate) from Baseline to Day 15 & Day 30. d. Findings from physical examination at each study visit. e. Investigator s overall safety & tolerability assessment during the study period Timepoint: Day 0- Visit 1 Day 15 2 days- Visit 2 Day 30 2 days- Visit 3 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Sahyadri Ayurvedic Life Pvt Ltd.
Outcome results
None listed