Effect of nasal administration of hemp seed oil in sleep disturbance

“A randomized control trial to evaluate the efficacy of Vijaya Beej Tail Nasya in Anidra (Insomnia Disorder) ?

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044602

Enrollment

100

Registered

2022-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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, Alzheimer’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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr Mohita Bohra

Uttarakhand Ayurved University

mohita.india@gmail.com9456370494

Outcome results