Health Condition 1: J988- Other specified respiratory disorders Health Condition 2: J989- Respiratory disorder, unspecified
Conditions
Interventions
None listed
Sponsors
VRD SANJEEVANI PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults of either sex aged 18 to 65 years inclusive 2 Habitual snoring 3 nights week for 1 month confirmed by self report and or bed partner report 3 PSQI total score 5 at baseline indicating poor sleep quality 4 Ayurvedic diagnosis of Kaphaja Shwasa Dushti or Nidra Vikara established by a qualified Kayachikitsa clinician 5 Willingness to maintain a daily sleep diary throughout the study period 6 Availability of a bed partner household member able to provide snoring frequency and loudness assessment at each visit 7 Freely willing to provide written informed consent in English Hindi or Marathi 8 Agreement to refrain from any other topical aromatic or nasal decongestant product sprays strips ointments during the study 9 Agreement to adhere to standard sleep hygiene advice provided at enrollment 10 ESS score 7 significant daytime sleepiness OR partner confirmed snoring causing significant sleep disturbance 11 BMI 18 5 and 35 kgm
Exclusion criteria
Exclusion criteria: 12 Confirmed severe obstructive sleep apnea OSA with AHI 30hr on polysomnography or home sleep test currently prescribed CPAP therapy Mild-to moderate OSA AHI 5-29 is NOT an exclusion these subjects represent the clinically relevant target population 13 Known hypersensitivity or allergy to any formulation component sesame oil coconut oil castor oil mustard oil Eucalyptus Camphor Peppermint Thyme Lavender Frankincense EOs Vasa Adhatoda vasica Tulsi Tagar Jatamansi Mulethi Ajwain Cinnamon or Black Pepper 14 Active skin conditions at Nabhi site contact dermatitis eczema active rash umbilical hernia abdominal wall infection or surgical scar 15 Pregnant women or lactating mothers 16 Current use of prescribed sedative hypnotic medications benzodiazepines Z drugs zolpidem zopiclone or opioid analgesics 17 Uncontrolled systemic illness active malignancy severe cardiac disease NYHA Grade III IV uncontrolled hypertension uncontrolled diabetes 18 Acute upper respiratory tract infection or sinusitis within the preceding 2 weeks rescreen after resolution 19 Confirmed nasal polyps deviated nasal septum requiring surgical correction or laryngeal structural abnormality as the sole mechanical cause of snoring 20 Significant hepatic disease 21 Participation in another interventional clinical trial within the preceding 3 months 22 Subjects living alone without any bedpartner or household member who can assess snoring snoring frequency secondary endpoint requires an informant 23 Inability or unwillingness to attend all 5 assessment visits or complete daily sleep diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index PSQITimepoint: BASE LINE DAY 10 DAY 20 DAY 30 DAY FU 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Snoring Frequency Self Reported & Bed PartnerReported VAS Snoring Severity Epworth Sleepiness Scale Berlin QuestionnaireTimepoint: BASE LINE DAY 10 DAY 20 DAY 30 DAY FU 60 | — |
Countries
India
Contacts
Public ContactDr Pawan Lekurwale
L N Ayurved College and Hospital Bhopal
Outcome results
None listed