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CTRI Number  CTRI/2022/09/045917 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the effectiveness of two Ayurvedic treatment procedures in Chronic Insomnia. 
Scientific Title of Study   A randomised controlled, clinical study to evaluate the efficacy of Nasya with the added effect of Ksheeradhara in nidranasa. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Rajalekshmi 
Designation  PG scholar Department of Panchakarma 
Affiliation  Government Ayurvedic Medical College Bangalore 
Address  PG scholar Department of Panchakarma Government Ayurvedic Medical College Dhanvantari Road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  8547284207  
Fax    
Email  rajalekshmianilk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ananta S Desai 
Designation  HOD and guide (Department of Panchakarma) 
Affiliation  Government Ayurvedic Medical College Bangalore 
Address  Professor and HOD Department of Panchakarma Government Ayurvedic Medical College Dhanvantari road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9448185896  
Fax    
Email  anantdesai30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Rajalekshmi 
Designation  PG scholar Department of Panchakarma 
Affiliation  Government Ayurvedic Medical College Bangalore 
Address  PG scholar Department of Panchakarma Government Ayurvedic Medical College Dhanvantari road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  8547284207  
Fax    
Email  rajalekshmianilk@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Medical College Dhanvantari road Bangalore 560009 
 
Primary Sponsor  
Name  Government Ayurvedic Medical College Bangalore 
Address  Government Ayurvedic Medical College Dhanvantari road Bangalore Karnataka 560009 EMAIL ID: principalgmac9@gmail.com CONTACT NO: 8022872848 
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 S Rajalekshmi  Government Ayurvedic Medical College Bangalore  OPD no 6A Government Ayurveda Medical College Bangalore 560009
Bangalore
KARNATAKA 		 8547284207

rajalekshmianilk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDIC MEDICAL COLLEGE BANGALORE DHANVANTARI ROAD BANGALORE 560009  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: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charaka Samhita, Procedure details: Local application of Murchita Tila taila to face and above shoulder for 10 minutes. Abhyanga is followed by sudation of these areas. )
(1) Medicine Name: Tila Taila, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Charaka Samhita, Procedure details: Sudation is done with a warm cloth soaked in warm water in urdwa jatru area for a duration of 10 minutes for 7 days. )
3Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita, Procedure details: Jatamansi taila is administered through nasal route in a dose of 8 drops for 7 days. Procedure is followed bu Gandusha and Dhoomapana as Paschat Karma. )
(1) Medicine Name: Jatamansi Taila, Reference: Priya Nighantu, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
4Comparator ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Ashtanga Hrudaya, Procedure details: Application of oil on scalp is done for 10 minutes. )
(1) Medicine Name: Murchita Tila Taila, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
5Comparator ArmProcedure-talam, तलम् (Procedure Reference: Ashtanga Hrdaya, Procedure details: Rasnadi Choorna is applied over the anterior fontanelle mixed with Murchita tila taila. )
(1) Medicine Name: Sahasra yoga, Reference: Rasnadi Choorna , Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 7 Days
6Comparator ArmProcedure-SirobastiH, शिरोबस्तिः (Procedure Reference: Ashtanga Hrdaya, Procedure details: Warm medicated ksheera paka is droipped over the forehead in a rhythmic manner for 7 days. )
(1) Medicine Name: Jatamasi Taiila, Reference: Prriya Nighantu, Route: Topical, Dosage Form: Ksheerpaka, Dose: 2500(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals between the age group of 20 to 60 years of either sex experiencing insomnia for a minimum of 3 months duration.
2. Individuals fit for Nasya karma
3. Individuals fit for Shirodhara 
 
ExclusionCriteria 
Details  1. Psychiatric illness like Schizophrenia
2.chronic Alcoholics
3.Acute painful conditions
4.Other serious medical conditions
5.Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and study the efficacy of Nasya karma with the added effect of Ksheeradhara in Nidranasha  14 days
Follow up on 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 2 
Date of First Enrollment (India)   01/10/2022 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 who provide a methodologically sound proposal.

  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 [rajalekshmianilk@gmail.com].

  6. For how long will this data be available start date provided 08-08-2022 and end date provided 07-11-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, controlled, parallel-group clinical study comparing the efficacy of Nasya for 7 days with the added effect of Kshheradhara for 14 days in 40 Nidranasha patients that will be conducted in the Government Ayurvedic Medical College, Bangalore in India. The primary outcome measure will be the Pittsburgh Sleep Quality Index at 21 days. 
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