| CTRI Number |
CTRI/2025/03/083512 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Study To Observe The Effect Of Suryabhedana Breathing Exercise In Nasal Blockage |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Suryabhedana Pranayama In The Management Of Nasanaha With Special Reference To Deviated Nasal Septum |
| 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 LAKSHMI PRIYA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Udayapura P O Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
7337737237 |
| Fax |
|
| Email |
lakshmipriyaanil1096@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. SAJITHA K |
| Designation |
PROFESSOR |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Udayapura P O Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr LAKSHMI PRIYA A |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of Swasthavritta, Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Udayapura P O Bangalore - 560082
Bangalore KARNATAKA 560082 India |
| Phone |
7337737237 |
| Fax |
|
| Email |
lakshmipriyaanil1096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research, Kankapura road, Udayapura P O Bangalore 560082 |
|
|
Primary Sponsor
|
| Name |
Dr LAKSHMI PRIYA A |
| Address |
Sri Sri College of Ayurvedic Science and Research, Kanakapura road, Udayapura P O Bangalore 560082 |
| 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 Lakshmi Priya A |
Sri Sri College of Ayurvedic Science and Research |
Department of Swasthavritta, Room no 7, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Udayapura P O Bangalore - 560082 Bangalore KARNATAKA |
7337737237
lakshmipriyaanil1096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J398||Other specified diseases of upperrespiratory tract. Ayurveda Condition: PRATINAHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:JALANETI- 14 DAYS, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:SURYABHEDANA PRANAYAMA - 14 DAYS, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 21-50 years irrespective of gender, religion, occupation and socioeconomic status will be selected.
Subjects presenting with complaints of nasal obstruction, headache, and facial pain.
Subjects will be selected based on the Nasal Obstruction and Symptom Evaluation (NOSE) score greater than or equal to 30 (out of a potential score of 100), with 30 defined as a cut off to differentiate subjects with nasal obstruction from those without.
Subjects who are fit for doing Suryabhedana Pranayama and Jalaneti.
Subjects who are willing to sign the consent form and participate in the study. |
|
| ExclusionCriteria |
| Details |
Subjects with Nasanaha associated with epistaxis, nasal tumour, septal abscess, sinusitis, nasal polyps and turbinate hypertrophies.
Subjects who are contraindicated for Suryabhedana Pranayama and Jalaneti.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in Nasanaha based on changes in SNOT score in comparison to baseline score criteria and also subjective parameters like – Obstruction to breathing, headache and facial pain.
|
1st Assessment–0th day
2nd Assessment–15thday
Follow up–30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in depth analyzed data on different aspects of disease and its treatment.
Improvement in quality of life based on changes in subjective parameter scores.
|
1st Assessment–0th day
2nd Assessment–15thday
Follow up–30th day
|
|
|
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)
|
14/05/2025 |
| 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="6" 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
|
Nasal disorders are among the most troublesome and irritating problems. Increased pollution, changed lifestyle, allergens etc. in today’s industrial world owes to the increased incidences of nasal disorders. Nasanaha one among the Nasagata roga is one such with clinical feature of nasal obstruction caused due to obstruction of Udana Vayu by Kapha Dosa. On the basis of clinical features of Nasanaha, it can be compared to Deviated Nasal Septum (DNS). DNS can lead to nasal obstruction, snoring, and other symptoms that affect daily activities and sleep quality. Septal Deviation is crucial due to its high prevalence, present in up to 80% of general population. Assessing the presence of DNS and managing it, is recommended to prevent the occurrence of sinusitis. Prana means breath / life and Ayama means to expand. Pranayama is the regulation of breath. In Yogic philosophy, Ida and Pingala are considered as two of the main Nadis or energy channels within the human body. The Pingala Nadi also referred to as Surya Nadi corresponds to sun’s energy connected to left side of the brain and right side of the body. In Suryabhedana Pranayama, the Pingala Nadi is activated by breathing in through the right nostril. Suryabhedana pierces Pingala Nadi and activates Pranashakthi. This Pranayama increases heat in the body and stimulates Pingala Nadi and sympathetic nervous system, excellent for purifying sinuses, destroys imbalances of Vata Dosa. Jalaneti is one among the Shatkriyas mainly indicated for nasal problems. It relieves Avarodha and can be credited for relief from the symptoms of Deviated Nasal Septum. Hence the study aims to evaluate the efficacy of Suryabhedana Pranayama in Nasanaha with special reference to Deviated Nasal Septum. |