| CTRI Number |
CTRI/2026/01/100995 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Foot Reflexology with Aromatic Oil improve sleep in healthy young adults |
|
Scientific Title of Study
|
Effect Of Foot Reflexology with Aromatic Oil to Assess Sleep Quality among Healthy Young Adults-A Randomized Controlled Trial |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRAKSHATHA |
| Designation |
PG SCHOLAR |
| Affiliation |
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES |
| Address |
ROOM NO-09
DEPARTMENT OF CLINICAL NATUROPATHY
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES
MOODUBIDIRE
Dakshina Kannada KARNATAKA 574225 India |
| Phone |
7259105460 |
| Fax |
|
| Email |
akshathajpoojary21@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DRLAKSHMEESH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES MOODUBIDIRE |
| Address |
ROOM NO-09
DEPARTMENT OF CLINICAL NATUROPATHY
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES
MOODUBIDIRE
Dakshina Kannada KARNATAKA 574225 India |
| Phone |
9741735734 |
| Fax |
|
| Email |
dr.lakshmeesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DRPRAJNA PRASHANTH SHETTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES MOODUBIDIRE |
| Address |
ROOM NO-09
DEPARTMENT OF CLINICAL NATUROPATHY
ALVAS COLLEGE OF NATUROPATHY &YOGIC SCIENCES
MOODUBIDIRE
Dakshina Kannada KARNATAKA 574225 India |
| Phone |
6364744817 |
| Fax |
|
| Email |
drprajnaprashanthshetty1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College Of Naturopathy & Yogic Sciences,Mijar
Moodubidire,Dakshina Kannada
karnataka
India - 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Akshatha |
| Address |
Alvas College Of Naturopathy and Yogic Sciences,Mijar
Moodubidire,Dakshina Kannada
Karnataka,India-574225 |
| Type of Sponsor |
Other [SELF SPONSOR] |
|
|
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 AKSHATHA |
Alva’s College of Naturopathy and Yogic Sciences, Mijar, Moodubidri |
Room No.-09
Department Of Clinical Naturopathy
Alvas College Of Naturopathy and Yogic Sciences,Mijar
Moodubidire,Dakshina Kannada
Karnataka,India-574225 Dakshina Kannada KARNATAKA |
7259105460
akshathajpoojary21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee For Human Studies Of Alvas College Of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FOOT REFLEXOLOGY WITH AROMATIC OIL |
Foot reflexology with lavender oil daily for 20 minutes including 10 minutes for each foot ,in each session for 30 days |
| Comparator Agent |
No Intervention |
control group is not given any interventions but they are asked to follow the daily routine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18 to 25 years
2. Both male and female subjects
3. Subjects who are wiling to participate in the study by signing an appraised consent form |
|
| ExclusionCriteria |
| Details |
1.Subjects who do not meet the inclusion criteria 2. Subjects who have a history of chronic sleep disorders
3. Subjects under medications
4. Subjects with bone deformity on foot
5. Subjects with known allergic reaction to aromatic oil
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality |
Assessments done at 2 time points:
1. Pre-assessments:Day 0 - Before giving the intervention
2. Post-assessments: Day 30 - After the one month intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Assessments done at 2 time points:
1. Pre-assessments:Day 0 - Before giving the intervention
2. Post-assessments: Day 30 - After the one month intervention |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="0" Months="7" 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
|
Sleep
disruptions such as poor sleep quality and insomnia are becoming more common in
young adults and they can cause exhaustion stress reduced focus and long term
health consequences Conventional drug based treatments while beneficial in the
short term can create side effects and dependence necessitating the need for
safe and non-pharmacological management solutions This study looks at the
efficacy of foot reflexology combined with lavender fragrant oil as a
complementary therapy for improving sleep quality in healthy young adults Foot
reflexology works by applying pressure to certain reflex sites on the feet that
correspond to various organs and bodily systems thereby promoting relaxation
and restoring physiological balance Lavender aromatherapy has relaxing
qualities and promotes the release of neurotransmitters like serotonin and
melatonin all of which are important for sleep regulation Earlier
studies using foot reflexology with aromatic oil to assess sleep quality were
done among insomnia individuals but not on healthy young adults Hence the
present study aims to measure the effect of foot reflexology with aromatic
oil to assess sleep quality among healthy young adults A
randomized controlled trial will be conducted on 60 participants between the
ages of 18 and 25 who will be randomly allocated to either the intervention or
control group The intervention group will receive 20 minutes of foot
reflexology with lavender oil per day for 30 days whereas the control group
will not receive any intervention Sleep quality and quality of life will be
measured before and after the trial using established assessment methods to
determine the interventions impact |