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CTRI Number  CTRI/2022/08/044602 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 19/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of nasal administration of hemp seed oil in sleep disturbance  
Scientific Title of Study   “A randomized control trial to evaluate the efficacy of Vijaya Beej Tail Nasya in Anidra (Insomnia Disorder)” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gyanendra Datta Shukla 
Designation  Associate professor 
Affiliation  Uttarakhand Ayurveda University 
Address  OPD no. 20, Gurukul Campus, Haridwar Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249404
India 
Phone  8791265576  
Fax    
Email  dr.gdshukla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohita Bohra 
Designation  Ph.D. Scholar 
Affiliation  Uttarakhand Ayurved University 
Address  Gurukul Campus, Haridwar Uttarakhand Ayurved University
Kripayanam, Gandhi road, Kankhal, haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  9456370494  
Fax    
Email  mohita.india@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohita Bohra 
Designation  Ph.D. Scholar 
Affiliation  Uttarakhand Ayurved University 
Address  Gurukul Campus, Haridwar Uttarakhand Ayurved University
Kripayanam, Gandhi road, Kankhal, haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  9456370494  
Fax    
Email  mohita.india@gmail.com  
 
Source of Monetary or Material Support  
Gurukul Campus, Uttarakhand Ayurved University 
 
Primary Sponsor  
Name  Dr Gyanendra Datta Shukla 
Address  Gurukul Campus, Uttarakhand Ayurved University 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gyanendra Datta Shukla   OPD Panchakarma Department  Gurukul Campus, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL 		 8791265576

dr.gdshukla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Uttarakhand Ayurved UNiversity  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nAvanam, नावनम् (Procedure Reference: Charak Siddhi Sthan 9th chapter, Procedure details: In this group, 50 patients will be administered 3 sittings of Vijaya beej tail Nasya. Each sitting includes 7 days with 3 days interval in between the sittings. 8 bindu of medicine will be instilled in each nostril per day in the evening (4-5 pm.) The patient will be taken to a comfortable room, without dust, extreme breeze, and sunlight. Mridu Abhyanga with Til Tail will be done in the supra-clavicular region i.e head, neck, forehead, face, ears, and shoulder followed by Mridu Swedana by dippi)
2Comparator Arm (Non Ayurveda)-tablet ZolpidemTablet Zolpidem for one month. Zolpidem is a non-benzodiazepine receptor modulator primarily used in the FDA-approved short-term treatment of insomnia aimed at patients with difficulty starting sleep. It improves measures of sleep latency, and sleep duration and reduces the number of awakenings in patients with transient insomnia. It also improves sleep quality in patients with chronic insomnia. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per ni
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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) 		 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 Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/08/2022 
Date of Study Completion (India) 29/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 3 publications 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 
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