FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (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
2Comparator ArmProcedure-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 "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. 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 Murdha Taila, 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 bowel     syndrome), 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 along with Basti in the management of Nidranash has been planned. 

According to Acharya Charak Basti is the best treatment for vata vyadhi. 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 bahya Sneha is used in the treatment of insomnia.

Primary objective-.

1.To compare the efficacy of Basti along with Shirodhara followed by Kakmachi Ghan Vati in the management 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 –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 is advised as per disease.

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

Outcome Changes 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]    Sharanghar Samhita madhyam khanda chapter 2 Shloka 1-2. Sharanghar Samhita madhyam khanda chapter 2 Shloka 6.

 


[i] Agnivesha, Charaka Samhita with Vidhyotini Commentary. Sutrasthana 11/35, Kasinath Pandey, redition,Varanasi: Chaukhambha Bharti Academy; 2001; p 227

[ii] Agnivesha, Charaka Samhita with Vidhyotini Commentary. Sutrasthana 21/35, Kasinath Pandey, redition,Varanasi: Chaukhambha Bharti Academy; 2001; p 446

[iii] Fernandez-Mendoza, Julio, and Alexandros 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 Tripathi Ashtang hridayam nirmala hindi vyakhya, reprint 2019, Chaukhamba Sanskrit Prat- ishthan, Ashtang hridayam Sutra sthan 07/52, page no. 129

[v] Dr. Brahmanand Tripathi Ashtang hridayam nirmala hindi vyakhya, reprint 2019, Chaukhamba Sanskrit    Pratishthan, Ashtang hridayam Sutra sthan 20/01, page no. 244

[vi] Sushruta, Sushruta Samhita with Nibandha Sangraha commentary. Chikitsasthana 40/51-52, Kavi Ambikadutta Shastri, Varanasi: Chaukhambha Sanskrit Sansthan; 2019; p 228

 
Close