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
|
|
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
|
|
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. |