| CTRI Number |
CTRI/2025/08/093532 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Causes of Insomnia with Reference to Body Constitution (Prakriti) |
|
Scientific Title of Study
|
An Observational study to evaluate the Etiopathogenesis & Sharirik Prakriti in patients of Anidra 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 Prateek Vashist |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room number 98, Departarment of Roga Nidan Evum Vikriti Vigyan, Institute for Ayurved Studies and Research
Umri road Sector 8, Kurukshetra (136118)
Haryana
India
Kurukshetra
HARYANA
136118
India |
| Phone |
08059859529 |
| Fax |
|
| Email |
psv7876@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Godara |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room number 97, Departarment of Roga Nidan Evum Vikriti Vigyan, Institute for Ayurved Studies and Research
Umri road Sector 8, Kurukshetra (136118)
Haryana
India
Kurukshetra
HARYANA
136118
India |
| Phone |
08813020507 |
| Fax |
|
| Email |
dr.skgodara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Vashist |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room number 98, Departarment of Roga Nidan Evum Vikriti Vigyan, Institute for Ayurved Studies and Research
Umri road Sector 8, Kurukshetra (136118)
Haryana
India
Kurukshetra
HARYANA
136118
India |
| Phone |
08059859529 |
| Fax |
|
| Email |
psv7876@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Umri Road, Sector-8, Kurukshetra (136118), Haryana, India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Umri Road Sector 8, Kurukshetra 136118, Haryana, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prateek Vashist |
Institute for Ayurved Studies and Research |
Room number 98, Departarment of Roga Nidan Evum Vikriti Vigyan, Institute for Ayurved Studies and Research
Umri road Sector 8, Kurukshetra (136118)
Haryana
India
Kurukshetra
HARYANA |
08059859529
psv7876@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:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Already diagnosed patients of Anidra in age group of 25-50 years will be selected irrespective of sex for the study.
Patients willing to give consent.
Participants fulfilling Pittsburgh Sleep Quality Index (PSQI).
Participants fulfilling Symptom Rating Scale. |
|
| ExclusionCriteria |
| Details |
Critical and Terminal illness.
Night shift workers.
Lactating mother and pregnant women.
Patients with severe pain and history of trauma.
Patients with severe psychiatric disorders.
Cancer patients on chemotherapy or radiotherapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Etiopathogenesis and prakriti responsible for Anidra will be assessed and finalized. |
10-15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/09/2025 |
| 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
|
In Ayurveda, Nidra (sleep) is one of the three essential pillars of life, supporting both physical and mental health. Its absence, called Anidra (insomnia), is linked to vitiation of Vata, Pitta, and Rajo Guna and is described as a Vata Nanatmaja Vikara. Classical texts mention stress, irregular diet, fasting, emotions, and lifestyle factors as its main causes. In modern medicine, insomnia is defined as difficulty in initiating or maintaining sleep and affects 15 to 30 percent of the global population, largely due to stress and lifestyle habits. Poor sleep impacts the nervous system, endocrine system and digestive systems, reducing overall well-being. Prakriti plays a role in susceptibility: individuals with Vata Prakriti are more prone due to restlessness and anxiety, while Pitta Prakriti individuals may face disturbances from intense emotions and metabolism. Kapha Prakriti is usually less affected but may experience hypersomnia. |