| CTRI Number |
CTRI/2025/12/099988 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Pulse Reading Helps Understand Sleep Problems. |
|
Scientific Title of Study
|
Correlation of Nadi Tarangini® Parameters with Polysomnographic and Subjective Sleep Scales in Primary Insomnia : A Cross-Sectional Analytical 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 Anisha sethi |
| Designation |
Pg scholar |
| Affiliation |
shri dhanwantry ayurvedic college and hospital chandigarh |
| Address |
Department of Rog Nidana evum Vikriti vigyana
Shri Dhanwantry Ayurvedic college and hospital sector 46 B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7889864342 |
| Fax |
|
| Email |
anishasethi1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit srivastava |
| Designation |
Professor and PRINCIPAL |
| Affiliation |
shri dhanwantry ayurvedic college and hospital chandigarh |
| Address |
Department of Rog Nidana Evum Vikriti Vigyana
shri Dhanwantry ayurvedic college and hospital Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9781110780 |
| Fax |
|
| Email |
sumitpankaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit srivastava |
| Designation |
Professor and PRINCIPAL |
| Affiliation |
shri dhanwantry ayurvedic college and hospital chandigarh |
| Address |
Department of Rog Nidana Evum Vikriti Vigyana
shri Dhanwantry ayurvedic college and hospital Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9781110780 |
| Fax |
|
| Email |
sumitpankaj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Dhanwantry ayurvedic college and hospital |
| Address |
Shri Dhanwantry ayurvedic college and hospital sector 46 B Chandigarh, 160047 |
| Type of Sponsor |
Private 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 Anisha sethi |
shri dhanwantry ayurvedic college and hospital chandigarh |
Department of Rog Nidana Evum Vikriti Vigyana
shri Dhanwantry ayurvedic college and hospital Chandigarh sector 46 B chandigarh
Chandigarh
CHANDIGARH |
7889864342
anishasethi1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18 to 70 years
Diagnosed with Primary Chronic Insomnia per DSM 5 criteria
Sleep difficulty more than or equal to 3 nights per week for more than or equal to 3 months
ISI score more than 14
Maintaining basic sleep hygiene
Willingness to provide written informed consent
Not taking sedatives or hypnotics
|
|
| ExclusionCriteria |
| Details |
Secondary insomnia due to depression, chronic illness, or substance abuse
On antidepressants more than 4 weeks
Use of CNS stimulants, narcotics or steroids
Irregular sleep due to work or family commitments
Respiratory or GERD or neurological comorbidities
Obstructive sleep apnea
Psychiatric disorders
Terminal illness, pregnant, lactating women
Excessive caffeine, alcohol, substance use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective correlations established between Ayurvedic pulse diagnostic parameters (measured via Nadi Tarangini) and biomedical sleep diagnostics, including polysomnography findings and subjective sleep scale scores, in subjects with primary insomnia. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Classification patterns derived from Nadi Tarangini readings that distinguish between Ayurvedic clinical entities such as Nidranasha (complete loss of sleep) & Alpa Nidra (reduced sleep).
Predominant doshic profiles (Vata, Pitta, Kapha) identified among primary insomnia subjects based on Nadi Tarangini assessments.
Statistical correlations between specific doshic dominances & types of sleep disturbances (e.g., delayed sleep onset, fragmented sleep), supporting the development of personalized, dosha-based Ayurvedic treatment protocols for insomnia.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/01/2026 |
| 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="4"
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
|
The study aims to evaluate the correlation between Nadi Tarangini® pulse diagnostic parameters and polysomnographic findings along with subjective sleep scales (ISI, ESS, PSQI) in patients with primary insomnia. It follows a cross-sectional analytical design with 68 participants diagnosed using DSM-5 criteria. The research seeks to integrate Ayurvedic pulse-based assessment with modern sleep diagnostics to differentiate Nidranasha vs. Alpa Nidra and identify doshic patterns linked with sleep disturbances. Expected outcomes include developing a holistic, integrative diagnostic framework for insomnia and establishing objective correlations between pulse characteristics and sleep architecture. |