Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: Cannasen Nasal Spray Night: A Nasal Spray containing herbal blend with Mustard Oil Base
Dosage: 1 pump
Frequency: Once during bedtime
Duration: 1 month
Control Intervention1: Placebo Na
Sponsors
Cannordic A/S
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient from 18 to 65 years of age. 2. Patient with the history of seasonal pollen allergy. 3. If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 4. Patient that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 5. Patient willing to avoid participation in any other interventional clinical trial for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Females that are pregnant, breast feeding, or planning to get pregnant during the study. 2. Patient that have participated in any other interventional clinical trial in the previous 30 days. 3. Patient with known sensitivity to any of the constituents of the investigational product. 4. Patient that are taking applying other product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Subject Global Assessment (SGA)Timepoint: Day 1 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pittsburgh Sleep Quality Index ScoreTimepoint: Day 1 and day 30;Change in the ISI(Insomnia Severity Index) ScaleTimepoint: Day 1 and day 30;Change in the QOL ScoreTimepoint: Day 1 and day 30 | — |
Countries
India
Contacts
Public ContactPuneet Mittal
Mittal Global Clinical Trial Services
Outcome results
None listed