| CTRI Number |
CTRI/2026/02/103461 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yogic cleansing technique on lung function in patient with bronchial asthma |
|
Scientific Title of Study
|
Effect of vaman dhauti and jala neti on pulmonary function in patients with bronchial asthma - A randomised 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 |
Dr J Preetha |
| Designation |
PG scholar Department of yoga |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of yoga, Second floor, Post Graduate block, Government Yoga ana Naturopathy Medical College and Hospital, Arumbakkam, Chennai-600106
Chennai TAMIL NADU 600106 India |
| Phone |
6383216107 |
| Fax |
|
| Email |
prithakumar.lavan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr KS Lakshmi |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga, Second floor, Postgraduate block, Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai - 600106
Chennai TAMIL NADU 600106 India |
| Phone |
9841073029 |
| Fax |
|
| Email |
lakshmikaran28@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr J Preetha |
| Designation |
PG scholar Department of yoga |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai -106 |
| Address |
Department of yoga, second floor, Postgraduate block, Government yoga and naturopathy medical college and hospital, chennai - 106
Chennai TAMIL NADU 6000106 India |
| Phone |
6383216107 |
| Fax |
|
| Email |
prithakumar.lavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopatrhy Medical College and Hospital, Arumbakkam chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai-600106 |
| 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 |
| Dr J Preetha |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
Government Yoga and Naturopathy Medical College and Hospital, Department of Yoga, Second floor, PG block, Arumbakkam, Chennai
Chennai 106 Chennai TAMIL NADU |
6383216107
prithakumar.lavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital,chennai instituitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
The participants will be given usual care as needed, and no yogic intervention will be given during the 3-week study period. |
| Intervention |
vaman dhauti and jala neti |
Patients will be asked to sit in a squatting position drink approximately 2 liters (about six glasses) of prepared lukewarm saline water (Adding 2 tea spoonful of salt to 2 litres of luke warm water). drinking continuously until the stomach feels full, then lean forward, gently insert the middle and index finger of the right hand into the throat, stimulating the back of the tongue to trigger the gag reflex. Once vomiting begins, the water will be allowed to expel naturally without straining, This may be repeated until the stomach is completely emptied. Upon completion, patients will perform Jala Neti.
Jala neti - Patients will be asked to fill the Neti pot with lukewarm saline solution (preparing as explained before). They will be asked to stand and lean forward and the head tilted downward or to sit comfortably in a squatting position. Patients will then hold the pot in one hand and gently insert the spout into one nostril, ensuring a secure and comfortable seal to prevent leakage. They will be guided to tilt their head to the opposite side while keeping the mouth open, allowing the saline solution to flow through one nostril and out the other, breathing calmly through the mouth, practising for 10 to 20 seconds. Following this, patients will remove the spout and gently blow out through the opposite nostril to clear residual water and mucus. The procedure will then be repeated on the other side. Patients will be asked to complete the practice by drying the nostril. They will be instructed to stand upright with feet shoulder-width apart, lean slightly forward, and forcefully exhale through one nostril while closing the other, repeating the process about 15 times per side. Finally, they will exhale through both nostrils simultaneously until all residual water is expelled from the nasal passages.Vaman dhauti and Jala neti will be practised on empty stomach in the morning, weekly thrice, for 3 weeks, practising both on the same day, with approximate duration of 20 minutes per session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with mild to moderate severity of symptoms based on GINA guidelines
2. Participants who are not under any treatment regime. |
|
| ExclusionCriteria |
| Details |
1. Habits of tobacco chewing, smoking, alcoholism
2. Women during pregnancy and menstruation.
3. Participants with other respiratory conditions such as pneumonia, COPD, pulmonary edema and Bronchiectasis.
4. Participants with severe persistent asthma.
5. Participation in other clinical trials.
6. Patients with history of hernia, raised intracranial pressure, heart disease, stroke, acute peptic ulcer disease, current or recurrent ear infections.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Forced vital capacity - FVC,
Forced expiratory volume in one second - FEV1,
Forced Expiratory Volume in 1s and Forced Vital Capacity Ratio -FVC/FEV1,
Peak expiratory flow rate - PEFR. |
FVC,FEV1, FEV1 and FVC ratio, PEFR will be taken before and three weeks after the first and last day of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Immunoglobulin E (Ig E). |
Serum Ig E level will be taken before and three weeks after the first and last day of intervention |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/02/2026 |
| 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="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
|
A randomized controlled study design will be adopted for this study, 40 participants will be recruited from Government Yoga and Naturopathy medical college and hospital, chennai. Participants will be randomly allocated into study group (vaman dhauti and jala neti) or control group (without intervention) using computerized randomization technique, allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique. The study group will undergo vaman dhauti followed by jala neti practice for the duration of 20mins early in the morning in empty stomach, weekly thrice for three weeks . The control group will be given usual care as needed, and no yogic intervention will be given during the 3 weeks. Assessment of FVC, FEV1, FEV1 to FVC ratio, PEFR and Serum Ig E will be taken before and 3 weeks after the intervention for both group. |