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CTRI Number  CTRI/2022/01/039793 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 26/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening
Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of milk prepared by boiling coarse powder of herbal drugs(i.e. Brihat Panchmula and Balamula) in it, on people having problem in sleeping/disturbed sleep quality and quantity due to excessive use of gadgets/screens(e.g computer, mobile, tablet, television) especially during night. 
Scientific Title of Study   Conceptual study of Nidra and to evaluate the efficacy of "panchamuladi siddha dugdha" in management of Nidranasha (insomnia) due to excessive screen time in purview of "pushti swapn kranam".  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Priyanshu Chauhan 
Designation  MD Scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Room no.714,7th.floor,Department Of Samhita And Siddhant, Academic Block,All India Institute Of Ayurveda,Gautampuri,Sarita vihar,Mathura road,New Delhi-110076
Room no.716,7th.floor,Academic block,All India Institute Of Ayurveda, Gautampuri,Sarita vihar,Mathura road,New Delhi-110076
South
DELHI
110076
India 
Phone  9711360088  
Fax    
Email  priyanshuchauhan028@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute Of Ayurveda 
Address  Room no.714,7th.floor,Academic block,All India Institute Of Ayurveda,Gautampuri,Sarita Vihar Mathura road,New Delhi-110076

South
DELHI
110076
India 
Phone  8058282620  
Fax    
Email  nidhisharma04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Mahesh Vyas  
Designation  Head Of Department 
Affiliation  All India Institute Of Ayurveda 
Address  Room no.716,7th.floor,Academic Block,All India Institute Of Ayurveda,Gautampuri,Sarita vihar Mathura road,New Delhi-110076
All India Institute Of Ayurveda,Gautampuri,Sarita vihar Mathura road,New Delhi-110076
South
DELHI
110076
India 
Phone    
Fax    
Email  drmaheshkvyas@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda, Gautampuri, Sarita vihar, New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda,Gautampuri,Sarita Vihar Mathura road,New Delhi-110076 
Type of Sponsor  Research institution and hospital 
 
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 
Vd Priyanshu Chauhan  All India Institute Of Ayurveda, New Delhi  OPD 2,Ground Floor,Hospital Block,All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,New Delhi-110076
South
DELHI 		 9711360088

priyanshuchauhan028@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: निद्रानाश,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchamuladi siddha dugdha, Reference: Bhaisajya ratnavali,chapter 26th.verse 83, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Ksheerpaka shall be prepared in accordance with the methods given in Sarangdhar samhita.
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Nidanparivarjan along with the intervention(panchmuladi shadhit milk) , Pathya/Apathya:yes, Pathya:Evening use of blue light blocking glasses and application of a blue wave length light filter (night shift settings) on the electronic screens. , Apathya:use of TV near bedtime. Avoid use of computer, mobile phone atleast half an hour before bedtime.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with classical sign and symptoms of Nidranasha irrespective of race,gender,occupation,
religion,caste and education.
People who are having problem in sleeping (insomnia)
atleast three times per week during last month.
 
 
ExclusionCriteria 
Details  Individuals with comorbidities like epilepsy,
hypertension, diabetes, Asthma, tuberculosis, carcinoma, schizophrenia, psychosis and any other severe illness.
Individuals on any type of anxiolytic drugs, antidepressant therapy.
Pregnant women and lactating mother who are having any serious comorbidities like hypertension, diabetes.
Individuals doing travel and shift work.
People who are alcoholic, emotionally upset or stressed.
People who are undergone panchkarma procedures and
raktmokshana during the assessment and recruitment
People who are suffering from rheumatoid arthritis etc. diseases having pain as a symptom.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in cardinal sign and symptoms of Nidranasha.
To study in detail the concept of Nidra. 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life.  90days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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   N/A 
Date of First Enrollment (India)   31/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published. 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyanshuchauhan028@gmail.com].

  6. For how long will this data be available start date provided 21-02-2024 and end date provided 20-02-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
In the view of increasing incidences of insomnia because of increased screen time, it is the need of the hour to find a safe and effective solution to the problem. The conventional treatment modalities have their own limitations and cannot be used for longer time. So, this study has been planned to find an effective and safe management according to principles of Ayurveda.
The criteria for diagnosis and assessment of patient of Nidranasha due to excessive screentime will be Athens Insomnia Scale and self developed questionnaire.
Patients of age group 18 to 60 years irrespective of education , gender ,race, occupation will be divided into two groups(46 patients each group)using random number table.
Patients of Group A will be advised to take Panchmuladi( bhritpanchmula and balamula) ksheerpaka 100ml orally at night before bedtime for two months and
 Patients of group B will be advised to take Nidanparivarjan (SOP will be provided) alongwith ksheerpaka for two months.
 Within group(before versus after treatment) comparison will be done by Wilcoxon Signrank test.
And between group comparison will be done by Mannwhitney U test.
 PRIMARY ENDPOINT will be Improvement in the Cardinal Sign and Symptoms of Nidranasha and to study in detail the concept of Nidra. SECONDARY ENDPOINT will be Improvement in the Quality Of
Life.
 
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