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CTRI Number  CTRI/2026/03/106776 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 14/03/2026
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   Management of stress induced insomnia. 
Scientific Title of Study   Evaluation of comparative efficacy of Tapasvini Churna and Brahmi Taila Shirodhara Versus Alprazolam in the Management of Stress-Associated Insomnia- A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DRRAZIA  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRRajimunnisaBegam shaik 
Designation  ASSOCIATE PROFESSOR 
Affiliation  KLE SHRI KBM AYURVEDA MAHAVIDYALA,SHAHAPUR,BELAGAVI,KARNATAKA 
Address  Department ofmanasaroga,shri BMK AYURVEDA MAHAVIDYALAYA ,SHAHAOUR,BELAGAVI,590003

Belgaum
KARNATAKA
590003
India 
Phone  07019454157  
Fax    
Email  dr.razia.sk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Bhushan Maishkar 
Designation  professor 
Affiliation  DMIHER 
Address  Department of kayachikitsa, Mahatmagandhi ayurveda medical college ,salod wardha, wardha,maharasthra.

Wardha
MAHARASHTRA
442001
India 
Phone  8983010655  
Fax    
Email  bhushan.mhaiskar@dmimsu.edu.in  
 
Details of Contact Person
Public Query  
Name  DrRajimunnisaBegam shaik 
Designation  Associate professor  
Affiliation  KLE Shri BMK Ayurveda Mahavidyallaya, Shahapur, Belagavi Karnataka, India. 
Address  Department of Manasaroga. KLE Shri BMK Ayurveda Mahavidyallaya, Shahapur, Belagavi Karnataka, India.

Belgaum
KARNATAKA
590003
India 
Phone  07019454157  
Fax    
Email  dr.razia.sk@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda Medical college and Hospital Salod, Wardha, Maharashtra, India,442004 
Mahatma Gandhi Ayurveda Medical College, DMIHER, Salod, Warda, Maharashtra, India,442004 
 
Primary Sponsor  
Name  Dr Rajimunnisa Begam Shaik 
Address  KLEs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Shahapur, Belagavi, Karnataka 590003 
Type of Sponsor  Other [Self] 
 
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 
DrRajimunnisaBegam shaik  DMIHER  Mahatma Gandhi Ayurveda medical college, Dept.of kayachikitsa, Salod, Wardha, M.S
Wardha
MAHARASHTRA 		 07019454157

dr.razia.sk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGACHRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:Z759||Unspecified problem related to medical facilities and other health care. Ayurveda Condition: NIDRA-VAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tapasvini churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm milk), Additional Information: -
2Comparator Arm (Non Ayurveda)-alprazolam1MG OD ,HS FOR 30 DAYS
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Between the age group 18 and 60 irrespective of gender
Diagnosed with primary insomnia as per research diagnostic criteria for primary insomnia25
ISI score of more than 8 but less than 21 points (mild to moderate insomnia) Willing to participate and able to consent
 
 
ExclusionCriteria 
Details  who are not satisfy the inclusive data are excluded for this study
comorbid psychiatric disorders and comorbid medical conditions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Insomnia remission, defined categorically as a score grade 2 (i.e 8-14 on the ISI)   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures will be evaluated using work stress scale.   2 yrs 
secondary outcomes will be measures from work place stress scale (WSS) Interpreting Workplace Stress Scale Scores, Total score of 15 or lower: Chilled out & relatively calm. Stress isn’t much of an issue. Total score 16 to 20: Fairly low. Coping should be a breeze, but you probably have a tough day now & then. Still, count your blessings. Total score 21 - 25: Moderate stress. Some things about your job are likely to be pretty stressful, but probably not much more than most people experience & are able to cope with. Concentrate on what can be done to reduce items with the worst scores. Total score 26 - 30: Severe  30 days 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 2 
Date of First Enrollment (India)   25/03/2026 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.razia.sk@gmail.com].

  6. For how long will this data be available start date provided 23-01-2025 and end date provided 23-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Adequate sleep (Nidra) is one of the essential factors to lead a healthy life. Ayurveda mentioned three important facts to keep a person in healthy status as Aahara (diet), Nidra (Sleep) & Bramhacharya (Celibacy) are mentioned as three Upastambha (sub-supporting pillars)executing an important role in maintaining the health.1Insomnia is one of the most common forms of sleep disturbance, with a prevalence of 18–33% in India .2-4Almost 15% of insomnia patients suffer from daytime consequences such as fatigue and malaise, memory and concentration difficulties, mood disturbances and irritability, and behavioral problems such as hyperactivity and aggression.5,6Currently, the mainstay treatment for insomnia is a behavioral approach and psychological treatment complemented with medications.

Tranquilizers and sedatives, such as benzodiazepines (alprazolam) and barbiturates, are the first-line pharmacological treatment for stress insomnia, however, there are concerns about residual symptoms, such as excessive sedation, tolerance, addiction, and neurological toxicity after longer usage.7 The overall management of stress induced insomnia seems to be unsatisfactory in the conventional system of medicine, as health surveys also show that 1.6 million adults with stress induced insomnia in the United States opt for complementary and alternative therapies annually.8 Therefore, there is a growing need to evaluate the role of alternative therapies in the management of insomnia


 
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