| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.
)
| | 2 | Comparator Arm | Procedure | - | 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.)
|
|
|
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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). |