None listed
Conditions
Interventions
Intervention1: Kashmir Lavender Lavandula angustifolia oil: Spray the lavender oil twice, approximately 200 microliters in total, each night before sleep for 14 days.
Control Intervention1: Placebo
Di
Sponsors
CSIR-Indian Institute of Chemical Technology, Hyderabad & Integrative Medicine, Jammu
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18 to 65 years. 2. Participant has self reported sleep issues such as difficulty falling asleep, frequent awakenings during the night, or daytime sleepiness. 3. Participant has total PSQI score greater than 5. 4. Weight not less than 50 kg for male and 45 kg for female and BMI between 18.50 and 30.00 kg per square meter inclusive. 5. Participants with screening vital signs within normal limits, or with values outside the normal range that are deemed clinically insignificant by the physician or principal investigator. 6. Participant able to read, understand and sign informed consent form. 7. Participant willing not to use spray or any type of fragrance before sleeping at night in the room. 8. Ready to follow study protocol until study completion.
Exclusion criteria
Exclusion criteria: 1. Participants who have night shift work or use prescription sleep medications. 2. Participants with PHQ 9 score greater than or equal to 10 and GAD 7 score greater than or equal to 10 during the screening visit. 3. Hypersensitivity to active ingredients of investigational product or any related chemical substances or excipients in the formulation. 4. Nasal allergy, nasal pathology such as history of bleeding or active bleeding, and nasal infections. 5. Refusal to undergo the procedure. 6. Known history or presence of the following: a. Cardiovascular, pulmonary, metabolic, hepatic, renal, hematological, gastrointestinal, ocular, endocrine including diabetes, immunologic, dermatologic, venereal, neurological, musculoskeletal or psychiatric disorders. b. Asthma, urticaria or other allergic reactions after taking any medication. c. Alcohol dependence, alcohol abuse or drug or chemical abuse such as marijuana THC, cocaine, morphine, benzodiazepines, barbiturates and amphetamine within the past one year. 7. Participants taking any prescription or non prescription medication, herbal, nutraceutical, ayurvedic products or special diet that might interfere with the study outcome. 8. Respiratory system dysfunction such as rhinorrhea or nasal polyps, or respiratory tract infection. 9. Participants with difficult airway or obstructive sleep apnea syndrome. 10. Pregnant women and breastfeeding mothers. 11. Females of childbearing potential refusing to use contraceptive methods. 12. Any other condition that prevents adequate understanding, cooperation and compliance with study procedures or any condition that could pose a risk to participant safety as per the investigator s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygieneTimepoint: Visit 1 to Visit 2 (Day 1 to Day 14 + 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygieneTimepoint: Spray the lavender oil twice, approximately 200 microliters in total, each night before sleep for 14 days | — |
Countries
India
Contacts
Public ContactDr Mangesh Shende
Akshar Global Clinical Research Private Limited
Outcome results
None listed