| CTRI Number |
CTRI/2025/07/090965 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the effect of Yakshma Nashana Suktam from Atharva veda in Nidranasha |
|
Scientific Title of Study
|
Effect of Atharvavedokta Yakshma nashana suktam in Nidranasha (Primary Insomnia) - A 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 Namratha N Kulal |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri,
Moodubidire, Dakshina kannada, Karnataka,574227, India,
department of Ayurveda Samhita and Siddhanta,OPD No 1,General
ward,ground floor
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9686891669 |
| Fax |
|
| Email |
namrathankulal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Rao |
| Designation |
Associate professor |
| Affiliation |
Alvas Ayurveda medical College and Hospital, Moodubidire,Dakshina kannada |
| Address |
Department of Ayurveda Samhita and
Siddhanta, Alvas Ayurveda Medical College and Hospital,
Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8105835295 |
| Fax |
|
| Email |
Drsmitharao12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Rao |
| Designation |
Associate professor |
| Affiliation |
Alvas Ayurveda medical College and Hospital, Moodubidire,Dakshina kannada |
| Address |
Department of Ayurveda Samhita and
Siddhanta, Alvas Ayurveda Medical College and Hospital,
Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8105835295 |
| Fax |
|
| Email |
Drsmitharao12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka India 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Namratha N Kulal |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka 574227 |
| 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 Smitha Rao |
Alvas Ayurveda Medical College and Hospital |
Department of Ayurveda Samhita and Siddhanta, Alvas Ayurveda Medical College and Hospital, Moodubidire
Dakshina Kannada
KARNATAKA |
8105835295
Drsmitharao12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G969||Disorder of central nervous system, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mantra-cikitsA, मन्त्र-चिकित्सा | (Procedure Reference: Atharvaveda, Procedure details: Each research participant will be explained about the Suktam & are instructed to hear the audio of the Yakshma Nashana Suktam which is 19 mins 24 seconds (14 rounds) before bed time.
Duration: 45 days
)
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
2. Patients diagnosed with Primary Insomnia.
3. Patients presenting with Lakshanas of Nidranasha (Primary Insomnia).
4. Patients those who are willing to listen to Mantras.
|
|
| ExclusionCriteria |
| Details |
1. Individuals having Secondary Insomnia.
2. Patient suffering from any other Psychiatric illness or disorder.
3. Insomnia caused by other medical conditions.
4. Drug or Alcohol induced sleep disorder.
5. Pregnant and Lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient falling asleep without difficulty |
10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient getting sleep & maintaining it until morning |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2025 |
| 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="0"
Months="6"
Days="1" |
|
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
|
This a clinical study where Atharvavedokta Yakshma Nashana suktam is given as intervention in Nidranasha patient for a duration of 45 days. Minimum 50 subjects
diagnosed as Nidranasha and fulfilling the inclusion criteria will be selected. Intervention: Atharvavedokta Yakshma
Nashana Suktam Method: Each research participant will be
explained about the Suktam and are instructed to hear the audio of the Yakshma
Nashana Suktam which is 19 mins 24 seconds (14 rounds) before bed time. Duration: 45 days . Subjects will be assessed before the
treatment, 15th day, 30th day and 45th day of
the treatment based on Athens Insomnia Scale (AIS) and Ayurvedic
Parameters which will be analyzed statistically.
Follow up period: Follow up
will be done on 60th day.
|