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 Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in Insomnia Severity Index to evaluate sleep quality pre and post-treatment
Study Overview
Brief Summary
Getting enough sleep is essential formaintaining good health, as explained in Acharya Charaka’s "Traya Upastambha"(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. Thephenomenon of Nidra is vital to the upkeep and reconstruction of thebody and psyche. Nidra is thus a tranquil quality bestowed by the naturalworld. Modern science has come to recognize the importance of sleep due to itsrestorative and healing properties for living things. There is a directcorrelation 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, beforerecommending any medication to patients suffering from sleeplessness, it isimperative that Manasabhava be thoroughly explored. The sedentarylifestyle of this age group contributes to the high prevalence of psychosomaticdiseases in society. Periodically, new comfort measures are designed. Man isstill mentally disturbed, which finally throws off the psycho-neuro-biologicalrhythm of sleep, a topic that is extensively covered within the category ofsleep disorders. In the Eighty Vata Nanatamaja Vyadhi, Charaka also mentioned Nidranasha, which can be linked to insomnia in modern science. According to theDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition, insomniais defined as difficulty falling asleep, staying asleep, or having enoughopportunity for sleep, along with associated impairment of daytime functioning,with symptoms present for at least four weeks. Although insomnia is the mostcommon complaint related to sleep, it degrades quality of life, so it requiresimmediate attention in the modern world. Approximately one-third of peopleworldwide suffer from various sleep disorders at some point in their lives,with insomnia being the most common.**Prevalence-**Dependingon 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% ofpeople have poor sleep (i.e., insomnia symptoms such as trouble falling asleepor staying asleep, early morning awakenings, or non-restorative sleep at anygiven 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. Inactuality, throughout the last three decades, modern psychiatry has experienceda dramatic advancement in its comprehension of mental capacities and relatedtopics. **Need of study-**Allopathic physicians give many kinds oftranquilizers to treat sleeplessness. Although they initially providesignificant relief from insomnia, prolonged use of them can have a number ofharmful side effects, including drug dependence. It seems that sleep issueswere widespread throughout the continuing COVID-19 pandemic. Higher levels ofstress have been linked to sleep issues. In a situation like this, effectivenatural insomnia treatment is immediately needed. This can be achieved by usingherbal remedies, receiving competent counselling, and maintaining anappropriate lifestyle. Numerous daily regimens, including Murdha Taila,Nasya, Snehana, and others, have been referenced in the Dinacharyaand Ritucharya chapters of Ayurvedic literature.
According to Ayurveda, the nose serves as theentrance to the cranium and that Nasya Karma can cure any sicknessaffecting the supraclavicular region[v].The cerebral centre in the head has an indirect connection to Nasa. NasyaKarma helps achieve a perfectly balanced oxygen level in the body andeliminates all morbid Doshas. Ayurvedahas a potent approach towards the treatment of Anidra by both internal and external medications. Need has alwaysbeen felt to develop certain Ayurvedic treatmentmodality for the management of Nidranash (Insomnia)which could be safe, effective, cost effective without any side effects. AcharayaSushruta has described fourteen *Kaal (*Time) of administration of Nasyaamong them one of the most suitable times for Nasya[vi].
Pouring of a liquid on theforehead or scalp is known as the Shirodhara, it can be done bydifferent medicaments like Taila, Takra, Kshira, Kwatha, etc. When it isdone with medicated Ghee or Taila, it is called Taila Dhara. ThisTaila Dhara is included in the varieties of Murdha Taila, whichare: Abhyanga, Seka, Pichu and Basti. They are told ‘UttarottarGunaprada’. Dhara is not only used in psychic disease but also usedin psychosomatic diseases like Insomnia, IBS (irritable bowel syndrome), psoriasis etc. Nowadays, it isindicated in almost all stress and psychosomatic disorders such as IBS, Asthma,Neurological disorders viz. Headache, epilepsy, and psychiatric disorders likepsychosis, neurosis, insomnia and also in psoriasis, eczema, H.T. etc. Keepingall these facts in mind, a comparative clinical trial of Shirodhara and Nasya alongwith Bastiin the management of Nidranash has been planned.
According to Acharya CharakBasti is the best treatment for vata vyadhi. Charak alsoexplained dominance of vata in insomnia. So basti can be used intreatment of insomnia. Snehana is also used in vata dosha that’swhy shirodhara as a bahya Sneha is used in the treatmentof insomnia.
Primary objective-.
1.To compare the efficacy of Bastialong with Shirodhara followedbyKakmachi Ghan Vati in themanagement of Anidra with special reference to Insomnia.
Secondary objective-
To evaluate the efficacy of Nasya along with Shirodhara followed by Kakmachi Ghan Vati in the management of Anidra with special reference to Insomnia
GROUP: A –Bastiand Shirodhara
Shirodhara with TrisatiPrasarani Taila 1litre willbe administered in morning time for 14 Days.
Matra Basti with Trisati Prasarani Taila will be administered to the patientfollowing the Shirodhara according to the SOP of PanchkarmaDepartment for 14 days.
Kakmachi Ghan Vati[i] willbe administered for 15 days after Shirodhara and Matra Bastischedule as Shaman Yoga in dose of 500 mg with Guda 3gm twice-daily.
Diet is advised as per disease.
GROUP: B –Nasya and Shirodhara
Nasya with Trisati PrasaraniTaila- 6 Bindu10(0.36ml) in each nostril will be administered inmorning time for 14 Days.
Shirodhara with TrisatiPrasarani Taila will be administered in morning time following Nasyakarma for 14 Days.
Kakmachi Ghan Vati will beadministered for 15 days after Nasya and Shirodhara schedule as shamanyoga in dose of 500 mg with Guda 3gm twice-daily.
TotalDuration of Trial: 30 Days
Outcome Changes in Insomnia SeverityIndex to evaluate sleep quality pre and post-treatment.
ETHICALCLEARANCE: Ethical clearance of the proposed trial will beobtained from institutional ethics committee, National Institute of Ayurveda,Jaipur
[i] Sharanghar Samhita madhyam khanda chapter 2Shloka 1-2. Sharanghar Samhita madhyam khanda chapter 2 Shloka 6.
[i]Agnivesha, Charaka Samhitawith Vidhyotini Commentary. Sutrasthana 11/35, KasinathPandey, redition,Varanasi: Chaukhambha Bharti Academy; 2001; p 227
[ii]Agnivesha, Charaka Samhitawith Vidhyotini Commentary. Sutrasthana 21/35, KasinathPandey, redition,Varanasi: Chaukhambha Bharti Academy; 2001; p 446
[iii] Fernandez-Mendoza, Julio, andAlexandros N Vgontzas. “Insomnia and its impact on physical and mental health.” Current psychiatry reports vol. 15,12 (2013): 418. doi:10.1007/s11920-013-0418-8
[iv]Dr. Brahmanand TripathiAshtang hridayam nirmalahindi vyakhya, reprint2019, Chaukhamba SanskritPrat- ishthan, Ashtanghridayam Sutra sthan 07/52, page no. 129
[v] Dr.Brahmanand Tripathi Ashtanghridayam nirmala hindi vyakhya, reprint2019, Chaukhamba Sanskrit Pratishthan, Ashtang hridayam Sutra sthan20/01, page no. 244
[vi]Sushruta, Sushruta Samhitawith Nibandha Sangrahacommentary. Chikitsasthana 40/51-52, Kavi Ambikadutta Shastri, Varanasi: Chaukhambha SanskritSansthan; 2019; p 228
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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-
- •4.Patients willing and able to participate in trial.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Changes in Insomnia Severity Index to evaluate sleep quality pre and post-treatment
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
