| CTRI Number |
CTRI/2024/09/074131 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sunlight and laughing for immunity |
|
Scientific Title of Study
|
Comparative study of sunbath and laughing therapy on lymphocyte count in healthy individuals-a randamised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen BR |
| Designation |
UG Scholar |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
room no 09 department of clinical naturopathy,shobavana campus mijar moodabidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9880519174 |
| Fax |
|
| Email |
naveenbr1493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineetha A N |
| Designation |
Associate professor |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9 Department of Clinical Naturopathy Moodbidre Mangalore Taluk Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8861064135 |
| Fax |
|
| Email |
vineethabnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal H M |
| Designation |
Assistant professor |
| Affiliation |
Alvas college of naturopathy and yogic sciences |
| Address |
Alvas college of naturopathy and yogic sciences, room no 9
Tenkamijar shobavana campus moodabidri
,
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9740435261 |
| Fax |
|
| Email |
hmprajwal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of naturopathy and yogic sciences shobavana campus mijar moodabidri 574225 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University Of Health Sciences |
| Address |
12, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 |
| Type of Sponsor |
Other [Under Graduate Research project grant] |
|
|
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 Vineetha AN |
Alvas Anandamaya Arogyadhama |
room no 3 department of naturopathy research Shobavana campus mijar moodabidri
Dakshina Kannada
KARNATAKA |
8861064135
vineethabnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee 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 |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
laughing therapy |
Inhale deeply and smile without opening mouth. Repeat it 8 times and take rest for 1 minute. Inhale deeply and laugh without noise opening mouth as you can. Repeat it 8 times and rest for 1 minute. Raise your hands while inhaling and start chanting Ho-Ho,Ha-Ha in rhythmic pattern. The speed of chanting is gradually increased and its crescendo is reached with a burst of laughter. Further laughter is continuous. Eye contact is very necessary. When one person starts laughing every one begins to follow suit.
Duration:15-20 minutes daily for 15 days |
| Intervention |
laughing therapy along with sun bath |
Sunbath: Subjects are asked to drink a glass of water then they are exposed to sun with minimal clothes. Head should be covered with wet towel. In beginning it is given for 3 to 5 minutes then gradually increased up to 15 to 20 mins.
Duration:15-20 minutes daily for 15 days
Laughing therapy: Inhale deeply and smile without opening mouth. Repeat it 8 times and take rest for 1 minute. Inhale deeply and laugh without noise opening mouth as you can. Repeat it 8 times and rest for 1 minute. Raise your hands while inhaling and start chanting Ho-Ho,Ha-Ha in rhythmic pattern. The speed of chanting is gradually increased and its crescendo is reached with a burst of laughter. Further laughter is continuous. Eye contact is very necessary. When one person starts laughing every one begins to follow suit.
Duration: 15-20 minutes daily for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy individuals,
2.who are willing to participate in the study
3.young adults |
|
| ExclusionCriteria |
| Details |
1.subjects with recent infection
2.subjects who are sensitive to sun
3.subjects with irregular menses |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lymphocyte count |
Before intervention
7th day of intervention
15th day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
16/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study evaluated the effects of Laughing Therapy (LT) and Laughing Therapy combined with Sunbath (LT&SB) on lymphocyte count and absolute lymphocyte percentage in healthy young adults. Both interventions were safe, well-tolerated, and did not cause significant changes in lymphocyte parameters, indicating preserved immune balance. The stability of lymphocyte counts can be attributed to Laughing Therapy reducing stress and modulating the hypothalamic–pituitary–adrenal axis (46,47), and Sunbath promoting vitamin D synthesis, which supports lymphocyte function and immune homeostasis (48). The LT&SB group showed slightly more consistent results, suggesting combined interventions may enhance immune stability (49). Overall, these non-invasive, cost-effective interventions may serve as complementary strategies for maintaining immune health and promoting holistic wellness.
|