Effect of nasal administration of hemp seed oil in sleep disturbance

Phase 2

Conditions: Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

Registration Number: CTRI/2022/08/044602

Lead Sponsor: Dr Gyanendra Datta Shukla

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patient fulfilling DSM-V criteria for insomnia disorder (non-comorbid).

2. Patient fit for Nasya procedure.

3. Patient does not have a history of hypersensitivity to the drug used

Exclusion Criteria

1. Sleep-wake disorders other than Insomnia disorder like- Obstructive sleep apnea, Restless leg syndrome, Narcolepsy, Parasomnia, Circadian Rhythm disorder, REM sleep behaviour disorder, NREM Sleep arousal disorder.

2. Insomnia duration of less than a week (Transient Insomnia).

3. Patient having Insomnia along with any major chronic systematic disorder like- uncontrolled diabetes, uncontrolled hypertension, chronic pain, cancer, asthma, heart disease, GERD, Alzheimerâ??s disease, etc.

4. Patient having any major psychiatric disorder like- anxiety, depression, psychosis, schizophrenia, etc.

5. Patients taking medicines that can cause insomnia like - SSRI (antidepressants-Prozac

and Zoloft), Dopamine agonist, anti-convulsant, B-agonist, theophylline, etc.

6. Severe alcoholics

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. APA level-2 sleep disturbance adult scale <br/ ><br>2. Pittsburgh Sleep Quality Index (PSQI) <br/ ><br>3. Ayurvedic parameters of Anidra/nidranash- <br/ ><br>i) Jrimbha (yawning) <br/ ><br>ii) Tandra (Drowsiness) <br/ ><br>iii) Angamarda (Body ache) <br/ ><br>iv) Bhram (Giddiness) <br/ ><br>v) Shiro Gaurav (Heaviness) <br/ ><br>vi) Jadyata (Stiffness) <br/ ><br>vii) Apakti (Indigestion) <br/ ><br>viii) Glani (Nausea)Timepoint: 4 time points: <br/ ><br>T1: Baseline (at the time of admission) <br/ ><br>T2: 10th day (after completion of 1st sitting of treatment) <br/ ><br>T3: 2oth day (after completion of 2nd sitting of treatment) <br/ ><br>T4:30th day (after completion of 3rd sitting of treatment)

Secondary Outcome Measures