CTRI/2025/04/084912 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On:
04/04/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparing the Effectiveness of medicated enema, nasal drops, Shirodhara, and Kakmachi Ghan Vati in Treating sleeplessness: A Randomized Clinical Study
Scientific Title of Study
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Basti and Nasya Along with Shirodhara followed by Kakmachi Ghan Vati in the Management of Anidra with special reference to 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
Dr Raj Kumar Banjarey
Designation
PG Scholar
Affiliation
National Institute of Ayurveda
Address
National Institute of Ayurveda, department of Panchkarma, room no 111, Amer road, 302002, Jaipur
Jaipur RAJASTHAN 302002 India
Phone
07697421995
Fax
Email
dr.raj.only4u@gmail.com
Details of Contact Person Scientific Query
Name
Prof Dr Gopesh Mangal
Designation
Professor and HOD
Affiliation
National institute of Ayurveda
Address
National Institute of Ayurveda, Amer road, department of Panchkarma, Room no 111, 302002 Jaipur
Jaipur RAJASTHAN 302002 India
Phone
8619849011
Fax
Email
gmangal108@gmail.com
Details of Contact Person Public Query
Name
Prof Dr Gopesh Mangal
Designation
Professor and HOD
Affiliation
National institute of Ayurveda
Address
National Institute of Ayurveda, department of Panchkarma, room no 111, Amer road, 302002 jaipur
Jaipur RAJASTHAN 302002 India
Phone
8619849011
Fax
Email
gmangal108@gmail.com
Source of Monetary or Material Support
National Institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur Rajasthan India 302002
Primary Sponsor
Name
National institute of Ayurveda
Address
Amer road, 302002, Jaipur, rajasthan
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
prof Dr Gopesh Mangal
National Institute of Ayurveda
panchkarma OPD (2), IPD wards of panchkarma (general male and female ward, cubicles, cottage and deluxe wards Jaipur RAJASTHAN
8619849011
gmangal108@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee National Institute of Ayurveda
(Procedure Reference: Chakradutta Vatavyadhi 22, Procedure details: after proper Sarvanga Snehana and swedana, and shirodhara, patient will be administered matra basti in dose of 72 ml. it will be followed by oral mediccation kakmachi ghan vati with 3 grams jaggery.) (1) Medicine Name: trisati prasarini taila , Reference: Chakradutta Vatavyadhi 22, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 14 Days(2) Medicine Name: trisati prasarini taila , Reference: Chakradutta Vatavyadhi 22, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 14 Days
2
Comparator Arm
Procedure
-
nasyam/ nastam, नस्यम्/ नस्तम्
(Procedure Reference: Chakradutta Vatavyadhi 22, Procedure details: shirodhara will be given to patient followed by proper local snehana swedana and nasya karma by trisati prasarini taila. it will be followed by Shaman mediine kakmachi ghan vati with 3 grams of jaggery for 15 days. ) (1) Medicine Name: trisati prasarini taila , Reference: Chakradutta Vatavyadhi 22, Route: Nasal, Dosage Form: Taila, Dose: 12(drops), Frequency: od, Duration: 14 Days(2) Medicine Name: trisati prasarini taila, Reference: Chakradutta Vatavyadhi 22, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 14 Days
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1.Patients between 20-60 years of age.
2.Patients According to Insomnia Severity Index more than 7
3.Patients with Pittsburg Scale score 2-3.
4.Patients willing and able to participate in trial.
ExclusionCriteria
Details
1.Patients with severe systemic disorders as Uncontrolled Hypertension, Cardiac Problem, Uncontrolled Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, Malignant disease, thyroid dysfunction etc.
2.Pregnant and Lactating Mothers.
3.Patient under any psychic mental condition.
4.Patient taking any Narcotics Medication.
5.Patients diagnosed with any congenital or hereditary mental disorder.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Changes in Insomnia Severity Index to evaluate sleep quality pre and post-treatment
30 days
Secondary Outcome
Outcome
TimePoints
nil
30 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 2
Date of First Enrollment (India)
01/09/2025
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="0"
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
Getting enough sleep is essential for
maintaining good health, as explained in Acharya Charaka’s "TrayaUpastambha"
(the three sub-triangles of the body)[i].
Sleep has been accorded equal weight with "Aahara" and "Brahmacharya."
To preserve excellent health, all three of these actions should be taken. The
phenomenon of Nidra is vital to the upkeep and reconstruction of the
body and psyche. Nidra is thus a tranquil quality bestowed by the natural
world. Modern science has come to recognize the importance of sleep due to its
restorative and healing properties for living things. There is a direct
correlation between sleep and mental health[ii].
Therefore, this innate desire for sleep may be impacted by Manasabhava,
an invisible signal such as greed, annoyance, fear, etc. Therefore, before
recommending any medication to patients suffering from sleeplessness, it is
imperative that Manasabhava be thoroughly explored. The sedentary
lifestyle of this age group contributes to the high prevalence of psychosomatic
diseases in society. Periodically, new comfort measures are designed. Man is
still mentally disturbed, which finally throws off the psycho-neuro-biological
rhythm of sleep, a topic that is extensively covered within the category of
sleep disorders. In the Eighty Vata Nanatamaja Vyadhi, Charaka also mentioned Nidranasha, which can be linked to insomnia in modern science. According to the
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, insomnia
is defined as difficulty falling asleep, staying asleep, or having enough
opportunity for sleep, along with associated impairment of daytime functioning,
with symptoms present for at least four weeks. Although insomnia is the most
common complaint related to sleep, it degrades quality of life, so it requires
immediate attention in the modern world. Approximately one-third of people
worldwide suffer from various sleep disorders at some point in their lives,
with insomnia being the most common. Prevalence-Depending
on the criteria, 8–40% of people in the general population experience insomnia.
While 8–10% of the general population suffers from chronic insomnia, 20–30% of
people have poor sleep (i.e., insomnia symptoms such as trouble falling asleep
or staying asleep, early morning awakenings, or non-restorative sleep at any
given time). Additionally, 4% of people regularly take sleeping drugs[iii]
.While Vagbhata used the phrase Aswapna in Vataj Nanatmaja Vikara[iv]4, he mentioned it in Trayopastambha. In Vataj Nanatmaja Vikar, Sharangadhara talked about Anidra. Therefore, Nidra, Anidra and Nidranash were important to all of the Acharyas. In
actuality, throughout the last three decades, modern psychiatry has experienced
a dramatic advancement in its comprehension of mental capacities and related
topics. Need of study-Allopathic physicians give many kinds of
tranquilizers to treat sleeplessness. Although they initially provide
significant relief from insomnia, prolonged use of them can have a number of
harmful side effects, including drug dependence. It seems that sleep issues
were widespread throughout the continuing COVID-19 pandemic. Higher levels of
stress have been linked to sleep issues. In a situation like this, effective
natural insomnia treatment is immediately needed. This can be achieved by using
herbal remedies, receiving competent counselling, and maintaining an
appropriate lifestyle. Numerous daily regimens, including MurdhaTaila,
Nasya, Snehana, and others, have been referenced in the Dinacharya
and Ritucharya chapters of Ayurvedic literature.
According to Ayurveda, the nose serves as the
entrance to the cranium and that Nasya Karma can cure any sickness
affecting the supraclavicular region[v].
The cerebral centre in the head has an indirect connection to Nasa. Nasya
Karma helps achieve a perfectly balanced oxygen level in the body and
eliminates all morbid Doshas. Ayurveda
has a potent approach towards the treatment of Anidra by both internal and external medications. Need has always
been felt to develop certain Ayurvedic treatment
modality for the management of Nidranash (Insomnia)
which could be safe, effective, cost effective without any side effects. Acharaya
Sushruta has described fourteen Kaal (Time) of administration of Nasya
among them one of the most suitable times for Nasya[vi].
Pouring of a liquid on the
forehead or scalp is known as the Shirodhara, it can be done by
different medicaments like Taila, Takra, Kshira, Kwatha, etc. When it is
done with medicated Ghee or Taila, it is called Taila Dhara. This
Taila Dhara is included in the varieties of Murdha Taila, which
are: Abhyanga, Seka, Pichu and Basti. They are told ‘Uttarottar
Gunaprada’. Dhara is not only used in psychic disease but also used
in psychosomatic diseases like Insomnia, IBS (irritable bowelsyndrome), psoriasis etc. Nowadays, it is
indicated in almost all stress and psychosomatic disorders such as IBS, Asthma,
Neurological disorders viz. Headache, epilepsy, and psychiatric disorders like
psychosis, neurosis, insomnia and also in psoriasis, eczema, H.T. etc. Keeping
all these facts in mind, a comparative clinical trial of Shirodhara and Nasya alongwith Bastiin the management of Nidranash has been planned.
According to Acharya Charak
Basti is the best treatment for vatavyadhi. Charak also
explained dominance of vata in insomnia. So basti can be used in
treatment of insomnia. Snehana is also used in vata dosha that’s
why shirodhara as a bahyaSneha is used in the treatment
of insomnia.
Primary objective-.
1.To compare the efficacy of Basti
along with Shirodhara followedby
Kakmachi Ghan Vati in the
management of Anidra with special reference to Insomnia.
Secondary objective-
To evaluate the efficacy ofNasyaalong with Shirodhara followed by Kakmachi Ghan Vati in the management of Anidra with special reference to Insomnia
GROUP: A –Basti
and Shirodhara
Shirodhara with Trisati
Prasarani Taila 1litre will
be administered in morning time for 14 Days.
Matra Basti with Trisati Prasarani Taila will be administered to the patient
following the Shirodhara according to the SOP of Panchkarma
Department for 14 days.
Kakmachi Ghan Vati[i]will
be administered for 15 days after Shirodhara and Matra Basti
schedule as Shaman Yoga in dose of 500 mg with Guda 3gm twice-daily.
Diet isadvisedas perdisease.
GROUP: B –
Nasya and Shirodhara
Nasya with Trisati Prasarani
Taila- 6 Bindu10(0.36ml) in each nostril will be administered in
morning time for 14 Days.
Shirodhara with Trisati
Prasarani Taila will be administered in morning time following Nasya
karma for 14 Days.
Kakmachi Ghan Vati will be
administered for 15 days after Nasya and Shirodhara schedule as shaman
yoga in dose of 500 mg with Guda 3gm twice-daily.
Total
Duration of Trial:30 Days
OutcomeChanges in Insomnia Severity
Index to evaluate sleep quality pre and post-treatment.
ETHICAL
CLEARANCE:Ethical clearance of the proposed trial will be
obtained from institutional ethics committee, National Institute of Ayurveda,
Jaipur
[i]
Agnivesha,CharakaSamhitawithVidhyotiniCommentary.Sutrasthana11/35,KasinathPandey,redition,Varanasi:Chaukhambha Bharti Academy; 2001; p 227
[ii]
Agnivesha,CharakaSamhitawithVidhyotiniCommentary.Sutrasthana21/35,KasinathPandey,redition,Varanasi:Chaukhambha Bharti Academy; 2001; p 446
[iii] Fernandez-Mendoza, Julio, and
Alexandros N Vgontzas. “Insomnia and its impact on physical and mentalhealth.”Current psychiatryreports vol. 15,12 (2013): 418.doi:10.1007/s11920-013-0418-8