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CTRI Number  CTRI/2020/03/023915 [Registered on: 12/03/2020] Trial Registered Prospectively
Last Modified On: 18/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   SHIROABHYANGA (head massage), PADABHYANGA(foot massage) and KARNABHYANGA (Ear lobule massage) IN ANIDRA (Insomnia) 
Scientific Title of Study   A COMPARATIVE STUDY ON SHIROABHYANGA, PADABHYANGA and KARNABHYANGA IN ANIDRA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG 
Address  Department of swasthvritta, Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG

Raipur
CHHATTISGARH
492010
India 
Phone  9424106544  
Fax    
Email  varsha.bams19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sasmita Tripathy 
Designation  Lecturer 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 
Address  Department of Swasthvritta, Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG

Raipur
CHHATTISGARH
492010
India 
Phone  8763650383  
Fax    
Email  Sasmita1980@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varsha 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG 
Address  Department of Swasthvritta, Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG

Raipur
CHHATTISGARH
492010
India 
Phone  9424106544  
Fax    
Email  varsha.bams19@gmail.com  
 
Source of Monetary or Material Support  
Department of swasthavritta and yoga Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG 
 
Primary Sponsor  
Name  Department of Swasthavritta and Yoga Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG 
Type of Sponsor  Other [Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG] 
 
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 
Varsha  Shri Khudadad Doongaji Government Ayurved Hospital Raipur CG  OPD No 6 Department of Swasthavritta and OPD No 2 Dept of Kaya Chikitsa and OPD No 9 Department of Panchakarma Shri Khudadad Doongaji Government Ayurved Hospital Raipur CG
Raipur
CHHATTISGARH 
9424106544

varsha.bams19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Karnabhyanga  Local application of sesame seed oil in ear (outer surface of ear) for 15 minute once in a day for 60 days. 
Comparator Agent  Padabhyanga  Local application of sesame seed oil in leg (sole) for 15 minute once in a day for 60 days. 
Intervention  Shiroabhyanga  Local application of sesame seed oil in head for 15 minute once in a day for 60 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.The patient age between 18-70 years irrespective of their caste, race and sex etc.
2.Patients having symptoms described in Ayurvedic and modern literature
3.Those having mental & physical fatigue.
4.Clinically diagnosed case of insomnia have been considered for the study.
 
 
ExclusionCriteria 
Details  1.Patient aged below 18 years and above 70 years.
2.Patient with known case of Diabetes mellitus, foot ulcer, psoriasis, any external injuries over foot and known case of any other systemic disease.
3.Occupational planto palmar diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improve quality of sleep  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Associated symptoms of anidra will be reduced which helps in attaining a good health.  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 2 
Date of First Enrollment (India)   16/03/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Nidra is considered as one of the Trividha Upastambhas (Ahar, Nidra, Bramhacharya) for maintainance of normal health, according to Acharya Charak, Acharya Sushruta, & Bhavprakash. Nidra plays a vital role in maintaining the body in healthy state. Adequate sleep is critical to good health yet many people have sleep related problems and incidence is higher among adults.

                            Anidra is the sleep deficiency quantitatively and qualitatively sleep. Anidra or Nidranasha is described as a disease under Nanatmaja-Vata-Vyadhi in Ayurveda classics. Proper balance of mental attributes Satva,Raja and Tama also account for maintaining the physiology of Nidra.Any mutual imbalance of the three mental faculties especially vitiation of Raja disrupts the normal sleep pattern and triggers Anidra. Anidra is mainly caused by vitiation of Vata,Pitta Dosha,mental stress,emaciation physical or mental trauma.

 

              Insomnia (inadequate quality and quantity of sleep) may be an outcome of stressful lifestyle, depressive illness, anxiety disorder, any psychiatric condition or any other pathological condition or a specific disorder. An estimated 30%-50% of general population is affected by insomnia and 10% have chronic insomnia with increased rates seen among older ages, female gender and presence of medical or psychiatric illness.

 

               Insomnia has become an important public health problem that requires definite diagnosis and effective treatment. Current study is focused on stress induced transient insomnia disorder stress of any kind mental or physical vitiate mainly Vata Dosha.For aforesaid vitiated Dosha various treatment are specified in texts.Abhyanga is one of these treatment  modalities.

                     

               Acharyas has mentioned that Abhyanga is a part of dinacharya procedure & it should be applied at least on head, feet & ear daily.Abhyanga is Vatashamak & also a part of Dincharya in Swasth Purush for maintainance & promotion of health.For Abhyanga Tila Taila has been selected for the group as it has Snigdha Guna, Madhura Rasa, Madhura Vipaka &Ushna Virya which help in Vatashamana.

NEED OF STUDY –

In modern medicine sedative and tranquilizer drugs are used to induce sleep in insomnia but it cannot be used for a long time as it leads to dependence.In such a scenario there is need for the efficient management of insomnia in a natural way Ayurveda treats Anidra by Shiroabhyanga, Padabhyanga & Karnabhyanga.

 SHIROABHYANGA-                                       

Shiroabhyanga is also a part of Dinacharya (daily regimen). Shira or head is known as Uttamanga which is the seat of Indriyas. Therefore all the functions of Gyanendriya & Karmendriya are controlled by the shira. Which are used to prevent and treat many psychosomatic illness.It is the best stress relieving treatment. It provides good strength, freshness & energy. It also improves metabolism, circulation & nerve conduction.

 PADABHYANGA-

local action like Snigdhata can be attained by the Sneha used for Abhyanga. The strokes which is done in Padabhyanga increases the local blood circulation.So Supti(numbness),Sankocha Stambha(stiffness) are relieved. Kharatwa/Rukshata(dryness/cracks) are also tackled by the Snigdha Guna of Sneha.Along with these local action it has systemic action in Anidra(insomnia) also acts as Chakshushya & has effect in Gridhrasi.

 KARNABHYANGA-

Shrotra is the Sthana of Vata. When ear skin get massaged with Tila Tail its active ingredients gets absorbed by Romakupa and through Swedawahi Strotasa and enters in circulation. Tila Tail is having Madhura Rasa and Ushna Virya which help in Vatashamana, Madhura Rasa and Madhura Vipaka will help in Pitta Shaman and Snigdha Guna will increase Snigdha Guna of Kapha. In this way the basic function of Vata get normalized. Indriyas get relaxed and due to this Mana which is Ubhayendriya also get relaxed.This mechanism helps in inducing sleep.

 
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