| CTRI Number |
CTRI/2026/02/104292 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effect of Red Color light Therapy for Improving Sleep in People with Vata Constitution |
|
Scientific Title of Study
|
OPEN LABEL SINGLE ARM CLINICAL TRIAL ON THE EFFICACY OF CHROMOTHERAPY ON NIDRA IN VATA PRAKRITI |
| 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 JOGERA AVINASH |
| Designation |
2nd year Pg scholar Department of kriya shareera |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka india |
| Address |
Department of Kriya Sharir, Academic Block, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India.
Hassan
KARNATAKA
573201
India |
| Phone |
8095256654 |
| Fax |
|
| Email |
avinashjogi1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaraj kamath |
| Designation |
Associate professor Department of Kriya shareera |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka india |
| Address |
Department of Kriya Sharir, Academic Block, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India.
Hassan
KARNATAKA
573201
India |
| Phone |
6362531966 |
| Fax |
|
| Email |
drnagarajkamath@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagaraj kamath |
| Designation |
Associate professor Department of Kriya shareera |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka india |
| Address |
Department of Kriya Sharir, Academic Block, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan – 573201, Karnataka, India.
Hassan
KARNATAKA
573201
India |
| Phone |
6362531966 |
| Fax |
|
| Email |
drnagarajkamath@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka india |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital hassan karnataka india |
| Address |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital Thanniruhalla BM Road hassan karnataka india |
| 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 Jogera Avinash |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
Dept of kriya shareera, prakriti opd
Hassan
KARNATAKA |
8095256654
avinashjogi1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hasaan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with vata pradhana prakriti have reduced sleep duration or poor sleep quality. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yes, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.vata Pradhana Prakriti inidividusls
2. Diagnosed with disturbed sleep |
|
| ExclusionCriteria |
| Details |
1.known history of psychiatric disorders and chronic illness
2.individuals on sleep medication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) global score after chromotherapy intervention |
Baseline (Day 0) and after completion of intervention ( Day 31 / End of study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in sleep latency (time taken to fall asleep) after intervention.
2.Change in total sleep duration (hours of sleep per night). |
Baseline (Day 0) and after completion of intervention ( Day 31 / End of study period |
|
|
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)
|
01/03/2026 |
| 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="2"
Months="0"
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
|
Sleep is one of the three essential pillars of life described in Ayurveda and is necessary for maintaining physical and mental health. Alpa Nidra refers to reduced or inadequate sleep and is commonly associated with aggravation of Vata Dosha. Individuals with Vata Pradhana Prakriti are more prone to sleep disturbances due to the inherent qualities of Vata such as dryness lightness and mobility. Modern lifestyle stress irregular routines and excessive sensory stimulation further contribute to sleep problems. Therefore a safe non pharmacological intervention that helps in pacifying Vata and improving sleep is needed.
Chromotherapy is a non invasive therapeutic method that uses specific colors to influence psychological and physiological functions. It is believed to promote relaxation and help regulate sleep through its effect on the nervous system. The present study is designed as an open label single arm clinical trial to evaluate the efficacy of chromotherapy in managing Alpa Nidra in Vata Pradhana Prakriti individuals. Participants fulfilling inclusion criteria will be assessed for Prakriti and baseline sleep parameters using standard assessment tools. Chromotherapy will be administered daily for a fixed duration over a defined treatment period. Pre and post intervention assessments will be compared and statistically analyzed to determine the effectiveness of the therapy. The study aims to establish chromotherapy as a safe cost effective supportive approach for the management of Alpa Nidra. |