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CTRI Number  CTRI/2025/02/081280 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 10/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of shirodhara with milk processed with jatamamsi at different time duration  
Scientific Title of Study   Efficacy of Shirodhara with Jatamamsi Siddha Ksheera at different time duration in the management of Nidranasha, Primary insomnia-A Randomized clinical study  
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 Sandhya A R  
Designation  2nd year PG scholar 
Affiliation  Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital 
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 13 and 26 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9620045373  
Fax    
Email  drsandhyaar2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun B Jainer 
Designation  Associate professor  
Affiliation  Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital  
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9900940333  
Fax    
Email  draruns@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun B Jainer  
Designation  Associate professor 
Affiliation  Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital  
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9900940333  
Fax    
Email  draruns@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara institute of ayurveda and hospital Anchepalya Bengaluru 560074 Karnataka India 
 
Primary Sponsor  
Name  Dr Sandhya A R 
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 13 and 26 Anchepalya Bengaluru Karnataka 560074 
Type of Sponsor  Other [(self)] 
 
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 
Dr Sandhya A R   Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital   OPD 13 and 26 Department of Panchakarma
Bangalore
KARNATAKA 
96200 45373

drsandhyaar2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: Sloka no 23 Gandusha vidhi adhyaya chapter 22 Astanga hrdaya sutrasthana, Procedure details: 50 grams of jatamamsi is added to 3 litres of milk & heated upto its boiling point.After this the flame is reduced & it is boiled for 15 minutes & filtered.Dhara yantra is placed above patients forehead supported by a stand. Varti is placed in it such that the distance between patient’s forehead & varti is 4 angula.Check the temperature of the dravya & as it flows, the dhara patra should be oscillated slowly laterally towards both sides (18-20/minute).The dravya that falls on the forehead is collected in a vessel placed under the droni. It is refilled into the dhara pot & a continuous flow is maintained. As the dravya cools it is reheated & procedure is continued for about 48 minutes. )
2Comparator ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: Sloka no 23 Gandusha vidhi adhyaya chapter 22 Astanga hrdaya sutrasthana, Procedure details: 50 grams of jatamamsi is added to 3 litres of milk & heated upto its boiling point.After this the flame is reduced & it is boiled for 15 minutes & filtered.Dhara yantra is placed above patients forehead supported by a stand. Varti is placed in it such that the distance between patient’s forehead & varti is 4 angula.Check the temperature of the dravya & as it flows, the dhara patra should be oscillated slowly laterally towards both sides (18-20/minute).The dravya that falls on the forehead is collected in a vessel placed under the droni. It is refilled into the dhara pot & a continuous flow is maintained. As the dravya cools it is reheated & procedure is continued for about 48 minutes.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Diagnosed case of primary insomnia/ presenting any of the lakshanas of Nidranasha (primary insomnia) for 4 weeks or above/Insomnia severity index above 8.

2.Age group between 18-50 years.

3.Male or female, irrespective of socio-economic status.

4.Subjects who are ready to take part in the study with their consent. 
 
ExclusionCriteria 
Details  1.Use of any substance with psychotropic effects or properties known to affect sleep wake cycle.

2.Subjects with secondary causes like breathing related sleep disorder, psychiatric related sleep disorder, sleep walking disorder.

3.Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in the lakshanas of Nidranasha(primary insomnia).

2. Reduction in insomnia severity index. 
Baseline 8th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
Enhanced quality of life with improvement in the quality & duration of sleep.  Baseline 8th day & 15th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   07/03/2025 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Nidra is one among the Trayopastambha and Adharaneeya vega and it plays a key role in the maintenance of Physical, Mental and Social well-being of a person. Sleep is a restorative phenomenon and sound sleep has shown to enhance growth, memory, immune system and life survival. Risk factors of long term sleep deprivation ranges from simple behavioral changes to increased risk in various systemic ailments like Hypertension, Cardio vascular diseases and other fatal conditions. Nidranasha can lead to Angamarda, Shirogaurava, Jadya, Jrumba, Glani, Bhrama, Tandra and Apakthi

Nidranasha can be correlated to insomnia. Insomnia is defined as difficulty in getting to sleep, staying asleep or having non- restorative sleep despite having adequate opportunity for sleep, together with associated impairment of daytime functioning, with symptoms being present for at least 4 weeks. Approximately 10% of the adult population suffers from an insomnia disorder and another 20% experiences occasional insomnia symptoms. Women, older adults, and people with socio economic hardship are more vulnerable to insomnia. Epidemiological studies suggest a strong increase of chronically disturbed sleep, including insomnia, with age. Estimates go up to 40-70% of the elderly population, and only ~20% report to sleep fine. A recent individual participant meta-analysis of insomnia symptoms across life-span in 1.1 million people from the general population reported that difficulty maintaining sleep peaked at 23% of the participants in the age category of 14 to 17 years, difficulty initiating sleep peaked at 23% at 18 to 25 years, while early morning awakening peaked only late in life, at 24% in participants older than 65 years of age

Shirodhara is one among the Murdhni taila and is mainly effective in Urdhvajatrugatavyadhis and Manasika vyadhis. It calms, relaxes and has a soothing effect on the mind. Jatamamsi (Nardostachys Jatamamsi DC) is tridoshara in action. It is Bhutagna, Balya, Medhya and possess Manasa doshaharaprabhava. It possess active chemicals like Valepotriates, Valeranone which act as a potent sedative and induces sleep, Sukhoshna ksheera is guru, snigdha, ushna and subsides vata. Shirodhara modulates the secretions of various neurotransmitters and hormones by adjusting the intensities of electromagnetic waves of brain. In this study an attempt is made to evaluate and compare the efficacy of Jatamamsi siddha ksheera shirodhara done for 1 Muhurta(48 minutes) and 1 Ghatika (24) minutes) in the management of Nidranasha (primary insomnia).
 
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