| CTRI Number |
CTRI/2025/12/099096 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how the timing of sleep and meals affects thyroid health and overall well-being in healthy adults. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO ASSESS THE ASSOCIATION BETWEEN
DIFFERENT PATTERNS IN THE TIMING OF THE SLEEP & / OR DIET WITH
BIOMARKERS OF THYROID FUNCTION AND QUALITY OF LIFE IN HEALTHY
INDIVIDUALS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasundhara |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Room no 312 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9354983580 |
| Fax |
|
| Email |
vasudhatiwari6058@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Meera K Bhojani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 302 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9428570231 |
| Fax |
|
| Email |
ayumeerabhojani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Meera K Bhojani |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Ayurveda New Delhi |
| Address |
Room no 302 Department of Kriyasharira Academic block All India
Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9428570231 |
| Fax |
|
| Email |
ayumeerabhojani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda New Delhi |
| Address |
All India Institute of Ayurveda Gautampuri sarita Vihar New Delhi
110076 |
| 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 |
| Vasundhara |
All India Institute of Ayurveda |
Room No 312
Department of
Kriyasharira Academic
block All India Institute
Of Ayurveda
Gautampuri Sarita
Vihar New Delhi
110076
South
DELHI
South
DELHI |
9354983580
vasudhatiwari6058@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 |
| Healthy Human Volunteers |
Apparently Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria of group A
1. Apparently healthy study participants in the age group 20 – 40 years of either sex will be
included in the study, irrespective of their caste, creed or religion
2. Subject willing to participate and able to give written informed consent.
3. Subjects having aligned (normal pattern) sleep timing & duration with morning alertness
and aligned (normal pattern) diet timing & frequency for minimum 5 days in a week.
Inclusion criteria of group B,C and D
1. Apparently healthy study participants in the age group 20 – 40 years of either sex will be
included in the study, irrespective of their caste, creed or religion
2. Subject willing to participate and able to give written informed consent.
3. Subjects having either misaligned (deviation from normal pattern) sleep or diet or both to
their respective group.
4. Subject having intermediate or evening alertness by MEQ. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria of group A, B, C and D
1. Patients with a major psychiatric illness like schizophrenia , depressive psychosis etc.
2. Patients with any systemic or metabolic disorder
3. Pregnant females, lactating mothers, perimenopausal and menopausal women.
4. Patients with alcohol dependency or drug dependency, that on hypnotic medicine or other
drugs which known to cause drowsiness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be a measurable association between different sleep and/or diet timing patterns and
thyroid profile biomarkers. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Identification of specific sleep and/ or diet timing pattern associated with variation in thyroid biomarkers.
2. Association between sleep/ or diet timing patterns & quality of life score as measured by a validated questionnaire. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
02/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title - A COMPARATIVE STUDY TO ASSESS THE ASSOCIATION BETWEEN DIFFERENT PATTERNS IN THE TIMING OF THE SLEEP & /OR DIET WITH BIOMARKERS OF THYROID FUNCTION AND QUALITY OF LIFE IN HEALTHY INDIVIDUALS.
Background - Our 24-hour ayurvedic biological cycles influences the sleeping and waking cycle, the release of hormones, eating pattern , digestion, temperature of our body and other important bodily functions. The ayurvedic or circadian cycle affects the gene expression metabolism and function of different system. Understanding the circadian rhythm , causes for its derangement , its pathogenesis and ways to reset the circadian rhythm.
OBJECTIVE - 1. To assess the core physiological outcome of different pattern in the timing of the sleep & / or diet on thyroid profile biomarkers in healthy individuals. 2. To identify specific pattern and their individual effect on thyroid profile biomarkers in healthy individuals. 3. To assess the association between different pattern in the timing of the sleep & / or diet and quality of life in healthy individuals.
Study Design - comparative observational study Participants - healthy Individuals aged 20 - 40 years
Method - Subjective Criteria - 1. SWASTHYA ASSESSMENT SCALE (CCRAS/IGIB) 2. PSQI 3. MORNINGNESS - EVENINGNESS QUESTIONNAIRE 4. CHRONONUTRITION PROFILE 5. WHO QUALITY OF LIFE SCALE
Objective Criteria 1. TSH 2.T3 3.T4 4. Free Thyroxine (fT4) 5. Free Triodothyronine (fT4) 6. FGF-21 7. Ultrasensitive TSH
Outcomes - 1. There will be a measurable association between different sleep and / or diet timing patterns and thyroid profile biomarkers. 2. Identification of specific sleep and /or diet timing pattern with variations in thyroid biomarkers. 3. Association between sleep and/ or diet timing pattern and quality of life scores as measured by a validated questionnaire. |