| CTRI Number |
CTRI/2025/02/080161 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Uddiyana Bandha on Autonomic Nervous system Function. |
|
Scientific Title of Study
|
Effect Of Uddiyana Bandha On Pupillary Light Reflex among Healthy Individuals- A Randomized Controlled 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 Deepika R |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First Floor), Department Of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7305415749 |
| Fax |
|
| Email |
deepikaravi2124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head of Department (Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First Floor), Department Of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika R |
| Designation |
post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block(First Floor), Department Of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7305415749 |
| Fax |
|
| Email |
deepikaravi2124@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr Deepika R |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Department of Yoga, Faculty Block (first floor), Kancheepuram, Chengalpattu - 603001 |
| 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 Deepika R |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Department Of Yoga, Faculty Block (first Floor), Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU |
7305415749
deepikaravi2124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute Of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Uddiyana Bandha for the improvement of Autonomic Function |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sitting posture |
The subject in control group will be asked to relax in a sitting posture for 20 minutes, for a period of 21 days. |
| Intervention |
Uddiyana Bandha |
Subjects will advise to sit in comfortable easy pose (sukasana) with the head and spine straight and
the hands resting on the knees. Subject will be advised to relax for five minutes with closed eyes. Inhale deeply through both the nostrils and exhale completely, press the palms of the hands on the knees, raise the shoulders and straighten the elbows. While exhaling pull the abdomen inward and upward. Hold the breathe externally and maintain for 30 seconds. Inhale and relax for 30
seconds. This makes one round. Practice it for 20 round daily for 21 days between 7:00 am to
8:00 am in empty stomach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy participants who has no past or present illness. |
|
| ExclusionCriteria |
| Details |
1. Participants with psychiatric illness.
2. Neurological conditions.
3. Systemic illness.
4. Recent injuries.
5. Refractive errors.
6. Pregnancy and lactating women.
7. Subject under any yogic or physical practices for the past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pupillary light reflex. |
Assessment of pupillary light reflex before starting the study and after completing the study (21 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Blood Pressure. |
Assessment of Blood Pressure before starting the study and after completing the study. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1"
Days="10" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-02-2025 and end date provided 11-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Yoga, an ancient practice, is widely recognised for promoting physical and mental well-being. It encompasses practices like asanas, pranayama, mudra, bandha, meditation and Shatkriyas. These Techniques harmonizes body and mind, addressing imbalances and enhancing overall health. Scientific evidences highlights Yogas ability to activate neuro-hormonal pathways, reduce sympathetic activity, alleviate tension and anxiety, and improve the autonomic nervous system and higher brain functions. Yoga also enhances cognitive functions such as memory, attention span and perception by activating dormant brain regions. Among yogic pratices, bandhas play a critical role in regulating physiological functions. Bandha refers to the voluntary contraction of specific body parts, combined with breath retention. The term Bandha means to Lock, Tighten or Hold. There are four main Bandhas- jalandhra, Uddiyana, Moola and Maha Bandha. Studies suggest that integrating Bandhas with other yogic practices improves forced vital capacity and breath holding time while balancing autonomic functions through sympathetic suppression. The ANS, part of the peripheral nervous system regulates involuntary physiological functions like heart rate, blood pressure, respiration, digestion and arousal. It has two divisions, the sympathetic and parasympathetic system. Conditions like hypertension, Diabetes, Obesity, Stress and anxiety exhibit heightened sympathetic activity, where as parasympathetic activity dominates in restful states. Over the past two decades heart rate variability (HRV), studies have demonstrated yogas role in enhancing parasympathetic functions, particularly through pranayamas, relaxation technique and meditation. ANS activity can be assessed using tools like HRV, Pupillary Light Reflex(PLR), Blood pressure variability (BPV) and baroreflex sensitivity(BRS). Pupillometry, a reliable and cost effective technique, measures autonomic activity by examining PLR. Pupil constriction, regulated by parasympathetic pathways, and dilation, driven by sympathetic pathways, reflect ANS functions. Despite studies on forced vital capacity and breath holding time, no research has explored Bandhas effects on Autonomic function. To address this gap, a randomized controlled trial will evaluate the impact of Uddiyana Bandha on ANS function using PLR in Healthy Individuals. Uddiyana Bandha meaning to rise up, involves abdominal contraction and external breath retention, stimulating digestive organs, reducing tension and enhancing vagal tone. By hypothesizing that Uddiyana bandha increases Parasympathetic activity via Vagal stimulation and stress induced inhibitory signals, this study aims to provide new insights into its effects on autonomic functions. |