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CTRI Number  CTRI/2025/10/095966 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 11/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Single Arm Study 
Public Title of Study   Clinical Evaluation of Siddharthakadi Agad Ghrita Nasya in Smartphone Addiction Induced Insomnia 
Scientific Title of Study   Clinical evaluation of Siddharthakadi Agad Ghrita Nasya in Smartphone addiction induced insomnia Nidranasha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhawana Mittal 
Designation  M.D.(AY.), Ph.D Assistant professor P.G. Deptartment of Agadtantra  
Affiliation  Rishikul Campus, Haridwar, Uttrakhand Ayurved University 
Address  P.G. Department of Agad Tantra & Vidhi Vaidyaka, Rishikul Campus, Haridwar, Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7891114932  
Fax    
Email  drbhawanamittal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhawana Mittal 
Designation  M.D.(AY.), Ph.D Assistant professor P.G. Deptartment of Agadtantra  
Affiliation  Rishikul Campus, Haridwar, Uttrakhand Ayurved University 
Address  P.G. Department of Agad Tantra & Vidhi Vaidyaka, Rishikul Campus, Haridwar, Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7891114932  
Fax    
Email  drbhawanamittal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Km Sheetal 
Designation  MD Scholar 
Affiliation  Rishikul Campus, Haridwar, Uttrakhand Ayurved University 
Address  P.G. Department of Agad Tantra & Vidhi Vaidyaka, Rishikul Campus, Haridwar, Uttarakhand 249401 India

Hardwar
UTTARANCHAL
249401
India 
Phone  7906862266  
Fax    
Email  dr.sheetalpipaliya@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Haridwar, Uttarakhand, India Pin code - 249401 Uttarakhand Ayurved University 
 
Primary Sponsor  
Name  Rishikul Campus, Haridwar, Uttarakhand Ayurved University 
Address  Rishikul govt. PG college and hospital, Haridwar, Uttarakhand, India, Pin code-249401 
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 Km Sheetal  Rishikul Campus Ayurvedic hospital, Haridwar  OPD No. 2, Department of Agad tantra, Rishikul ayurvedic hospital, Rishikul campus, haridwar, 249401 Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL 		 7906862266

dr.sheetalpipaliya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Uttarakhand ayurved University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Siddharthakadi Agad Ghrita, Reference: Charak Chikitsa Chapter no.9, shloka no. 69-72, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants with insomnia scoring from 15 or above as per the insomnia severity index (ISI) caused due to smartphone addiction.
2.Participants of either sex between the age group of 18 to 60 yrs.
3.Participants fit for Nasya Karma.
 
 
ExclusionCriteria 
Details  1.Participants suffering from insomnia caused by factors other than smartphone addiction like diabetes, hypertension, asthma, migraine etc.
2.Participants suffering from any other major psychiatric disorders like Schizophrenia etc.
3.Pregnant & lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE PARAMETERS
1. Angamarda
2. Shirogaurav
3. Jrumbha
4. Jadya
5. Glani
6. Bhrama
7. Apakti
8. Tandra  		 Follow up at an interval of 15 days.  
 
Secondary Outcome  
Outcome  TimePoints 
OBJECTIVE PARAMETERS
1. Sleep Induction
2. Awakening during the night
3. Final Awakening
4. Total sleep duration
5. Sleep quality
6. Wellbeing during day
7. Functioning capacity during the day
8. Sleepiness during day
 		 Score will be assessed at the baseline & on the 46th day( after 45th day) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   22/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This study aims to clinically evaluate the efficacy of Siddharthakadi Agad Ghrita Nasya in patients suffering from insomnia induced by smartphone addiction, a growing behavioral health concern particularly among young adults. The trial is a single-arm, open-label clinical study and will enroll 40 participants who will be selected from OPD No. 2 of Rishikul Campus, Haridwar, based on specific inclusion and exclusion criteria. The treatment duration will be 45 days. Assessments will be carried out using both subjective and objective parameters. The intervention consists of Pratimarsha Nasya (nasal administration) with Siddharthakadi Agad Ghrita, given twice daily for the entire treatment period. This study is conducted to introduce a cost-effective, holistic management approach for smartphone addiction-related insomnia, with the potential to reduce reliance on sedatives and minimize associated adverse effects.
 
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