Health Condition 1: G89-G99- Other disorders of the nervous system
Conditions
Interventions
None listed
Sponsors
Dr Kasthuri Nair A
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of Insomnia Disorder in accordance with DSM-5 criteria for a minimum duration of three months Baseline Insomnia Severity Index (ISI) score less than 7, indicating at least subthreshold insomnia. Willingness to comply with trial procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: Psychiatric comorbidities including schizophrenia, major depressive disorder, psychosis, epilepsy, or anxiety disorders. 2. Substance use disorders including alcohol or drug dependency. 3. Other primary sleep disorders such as narcolepsy, circadian rhythm disorders, parasomnias, or sleep-disordered breathing. 4. Chronic systemic diseases such as asthma, malignancies, liver cirrhosis, uncontrolled hypertension, diabetes mellitus, and chronic kidney disease. 5. Recent use of hypnotic medications or psychotherapy within the past four weeks. 6. Those who are having dandruff, alopecia and such kinds of Shiroroga. 7. Pregnant and lactating women. 8. Patients with a history of neurosurgical interventions including brain tumours. Those who are not willing to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insomnia severity and sleep quality assessed using validated sleep scales: Insomnia Severity Index (ISI) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS) Regensburg Insomnia Scale (RIS) Timepoint: Primary Outcome Assessment Time Point(s) Baseline (Day 0) Mid-treatment (DAY 15) End of treatment (DAY 29) Post-treatment follow-up (DAY 43) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in objective & subjective sleep parameters as recorded in a daily sleep diary, including sleep onset latency, number of nocturnal awakenings, total sleep time, & sleep efficiency. 2. Improvement in overall sleep quality & satisfaction, assessed through subjective participant reports & investigator evaluation. 3. Change in psychological status, assessed using Depression Anxiety Stress Scale (DASS-42). 4. Change in health-related quality of life, assessed using the SF-36 questionnaire. 5. Safety & tolerability, assessed through participant-reported local adverse effects (pruritus, burning sensation, stinging) using a Visual Analog Scale (VAS: 0 10) & clinical monitoring. Timepoint: Secondary Outcome Assessment Time Point(s) Baseline (Day 0) Mid-treatment (DAY 15) End of treatment (DAY 29) Post-treatment follow-up (DAY 43) | — |
Countries
India
Contacts
Public ContactDr Kasthuri Nair A
Pankajakasthuri Ayurveda Medical College and PG Centre
Outcome results
None listed