| CTRI Number |
CTRI/2025/02/080694 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Yoganidra for Better Sleep |
|
Scientific Title of Study
|
Study of the Effect of Yoganidra in Nidranash W.S.R 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 Hena Parveen |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
OPD of Swasthavritta and Yoga
Government Ayurvedic College and Hospital, Kadamkaun, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
7890598589 |
| Fax |
|
| Email |
drhernaparveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gangadhar Singh |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
OPD of Swasthavritta and Yoga
Government Ayurvedic College and Hospital, Kadamkaun, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gangadhar Singh |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
OPD of Swasthavritta and Yoga
Government Ayurvedic College and Hospital, Kadamkaun, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan,Patna, Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital |
| Address |
Department of Swasthavritta and Yoga
Government Ayurvedic College and Hospital, Kadamkaun, Patna, Bihar 800003 |
| Type of Sponsor |
Government medical college |
|
|
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 Hena Parveen |
Room no. 8 OPD of Swathavritta and Yoga |
Government Ayurvedic College and Hospital, Kadamkaun, Patna
Patna
BIHAR |
7890598589
drhernaparvern@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:YOGANIDRA, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients having nidranash due to stress
patients having classical features of nidranash mentioned in Ayurvedic Samhitas
patients having features of insomnia |
|
| ExclusionCriteria |
| Details |
patients having major psychiatric illness
Nidranash in pregnant and lactating mother
patients having other severe systemic illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduction in Insomnia severity index score
improvement in Pittsburgh Sleep Quality Index |
baseline, at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in stress levels
improvement in overall well being |
baseline, at 4 weeks and at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Insomnia is a growing concern affecting mental and physical well-being. Yoganidra, a guided relaxation technique, has been shown to reduce stress and improve sleep quality. this randomized clinical trial aims to evaluate the effect of Yoganidra on individuals suffering from Nidranash(insomnia). A total of 40 participants will be enrolled. the study will measure sleep quality using the Pittsburg sleep Quality index over 8 weeks. we anticipate that Yoganidra will significantly improve sleep quality and reduces stress |