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CTRI Number  CTRI/2024/11/077349 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Comparative Clinical Intervention To Evaluate The Efficacy Of Foot Massage Followed By Sleep Inducing Powder And Foot Massage Followed By Mamsyadi Decoction In The Management Of Sleeplessness 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Pada Abhyanga Followed By Nidrakara Churna And Pada Abhaynga Followed By Mamsyadi Kwatha In The Management Of Nidranasha Visavis Insomnia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indraja 
Designation  Post graduate scholar 
Affiliation  Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 
Address  room no 2
room no 2 department of kayachikitsa Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar560104
Bangalore
KARNATAKA
560104
India 
Phone  9449249584  
Fax    
Email  indrajakulkarni20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul khader 
Designation  professor 
Affiliation  Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 
Address  room no 2
room no 2 department of kayachikitsa Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar560104
Bangalore
KARNATAKA
560104
India 
Phone  9845199790  
Fax    
Email  abukaya2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul khader 
Designation  professor 
Affiliation  Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 
Address  room no 2
room no 2 department of kayachikitsa Sri kalabhyraveshwara swamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar560104

KARNATAKA
560104
India 
Phone  9845199790  
Fax    
Email  abukaya2003@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalabhairaveshwara Swamy Ayurvedic Medical college hospital and research center 
 
Primary Sponsor  
Name  Indraja 
Address  Sri kalabhairaveshwara swamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar banagalore 560104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran m goud  Sri Kalabyraveshwara swamy Ayurvedic Medical College Hospital and Research Centre  Room number 2,Department of Kayachikitsa,Sri Kalabyraveshwara swamy Ayurvedic Medical College Hospital and Research Centre Vijayanagar Bengaluru 560 104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
skamchrc  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G479||Sleep disorder, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: sushrutha chikitsa sthana 24/70-71, Procedure details: pada abhyanga with tungadrumadi taila for 5 minutes on each pada)
(1) Medicine Name: tungadrumadi taila, Reference: sahasrayoga 3 chapter, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 30 Days
(2) Medicine Name: nidrakara churna , Reference: bhaishajya ratnavali 21/10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: sushruta chikitsa sthana 24/70-71, Procedure details: pada abhyanga with tungadrumadi taila for 5 minutes on each pada)
(1) Medicine Name: tungadrumadi taila, Reference: sahasrayoga 3 chapter, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 30 Days
(2) Medicine Name: mamsyadi kwatha, Reference: ayurveda sara sangraha , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 24(ml), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  lakshanas of nidranasha
symptoms of insomnia
patient fit for pada abhyanga 
 
ExclusionCriteria 
Details  subjects with history of alcohol addiction
previously diagnosed psychiatric cases and under medication
systemic illness which interferes with the intervention 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to see the improvement in sleep pattern using pittsburg sleep quality index and insomnia severity index and lakshanas of nidranasha viz pada abhynaga followed by nidrakara choorna and pada abhyanga followed by mamsyadi kwatha in nidranasha visavis insomnia  before commencement of intervention - day 0
after completion of intervention - after 4 weeks
 
 
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)   25/09/2025 
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="25" 
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  
. NEED FOR THE STUDY:
In Present scenario, Life style has changed invariable in the society, busy life style,
improper ahara and vihara, poor sleep hygiene, work overload, stress and anxiety from day-to-
day activities have all contributed to significant changes in sleep quantity and quality.
Insufficient sleep increases the risk of developing obesity, diabetes, high blood pressure and
many other systemic diseases.1
Nidra is one of the Trayopastambha mentioned in Ayurveda along with Ahara and
Bramhacharya.2 Nidra is one of the thirteen Adharneeya vegas.3 One of the factors that is said
to have contributed to sthoulya and karshya is Nidra.4 It demonstrates the significance of sleep
for maintenance of health. The body’s restoration and rejuvenation are attributed to it.
Sleep is a state of consciousness that differs from alert wakefulness by a loss of critical
reactivity to events in the environment with a profound alteration in the respiration etc. when
the sense organs are exhausted due to exertion and at the same time manovahasrotas are
obstructed by shleshma the person goes to sleep.5
Aswapna, Alpanidra, Anidra, Nidra bhramsha are the synonyms of Nidranasha.
Aswapna is included in vatajananatmaja vikaras.6 Nidranasha is characterized by Angamarda,
Shirogourava, Jrumba, Jadya, Glani, Bhrama, Tandra, Apakti and Vatarogas.7 Nidranasha
can be correlated to Loss of sleep that is Insomnia in modern science. One of the most prevalent
sleep disorders that is frequently disregarded is Insomnia. Physical, emotional, and social
breakdowns are the outcome of insomnia’s effect on cognitive and neurological functioning.8
One year prevalence rate of 30-45% in adults is reported by a population survey.9
Approximately 10% of the adult population suffers from an insomnia disorder and another 20%
experiences occasional insomnia symptoms.10
In contemporary science the treatment of insomnia comprises of tranquilizers,
hypnotics, sedative drugs. These medications on long term use may induce various toxic effects
including drug dependency so, there is an immediate need for the management of insomnia.
Pada abhyanga a component of dincharya is said to induce sleep. According to
Sushruta Pada Abhyanga is Nidrajanaka,11 Tungadrumadi taila mentioned in Sahasrayoga has
ShitaVirya, Snigdhaguna, Vatapittahara property and has karmukata as Akshitarpana,
Snehana and Nidrajanaka is used for Pada Abhyanga in this study.12 Nidrakarachoorna
mentioned by both Bhaishajyaratnavali and Bhavaprakash as nidrajanaka contains
pippalimoola and guda, Pippalimoola due to its snigdha guna is Vatahara and due to its
Anushnasheeta virya along with guna of guda helps in increasing kapha thus promoting
sleep.13,14 Mamsyadi kwatha mentioned in Ayurveda sarasangraha contains Jatamamsi,
Ashwagandha, Parasikayavani which have sedative action thereby a treatment modality for
Nidranasha.15
Hence the present study is designed to compare the efficacy of Pada Abhyanga,
Nidrakara choorna and Mamsyadi kwatha in Nidranasha vis-à- vis Insomnia
 
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