Effect of nasal administration of hemp seed oil in sleep disturbance

Phase 2/3

Completed

• Conditions: Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,

• Registration Number: CTRI/2022/08/044602
• Lead Sponsor: Dr Gyanendra Datta Shukla

Brief Summary

This is a randomized, open, parallel-arm trial that will be conducted to assess and compare the safety and efficacy of Vijaya Beej tail Nasya with Zolpidem (5-10 mg.) in Anidra/ Nidranash (Insomnia) in 100 patients, who will be selected from 1 center in Uttarakhand. The primary outcome measure will be taken as given in APA LEVEL 2—Sleep Disturbance—Adult scale, Pittsburgh sleep quality index (PSQI), and symptoms of Anidra mentioned in Ayurvedic texts.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Study Completion: 2023-12-29
• Last Update Posted: 2025-04-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient fulfilling DSM-V criteria for insomnia disorder (non-comorbid).
• Patient fit for Nasya procedure.
• 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, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. APA level-2 sleep disturbance adult scale	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)
2. Pittsburgh Sleep Quality Index (PSQI)	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)
iii) Angamarda (Body ache)	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)
iv) Bhram (Giddiness)	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)
v) Shiro Gaurav (Heaviness)	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)
vi) Jadyata (Stiffness)	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)
vii) Apakti (Indigestion)	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)
viii) Glani (Nausea)	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)
3. Ayurvedic parameters of Anidra/nidranash-	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)
i) Jrimbha (yawning)	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)
ii) Tandra (Drowsiness)	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)

Trial Locations

Locations (1)

OPD Panchakarma Department; 🇮🇳 Hardwar, UTTARANCHAL, India

OPD Panchakarma Department

🇮🇳Hardwar, UTTARANCHAL, India

Dr Gyanendra Datta Shukla

Principal investigator

8791265576

dr.gdshukla@gmail.com