| CTRI Number |
CTRI/2025/11/097961 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Guided Deep Breathing] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
An interventional study to find if 6 weeks of simple guided deep-breathing exercise improve nerve health and reduce inflammation in participiants with rheumatoid arthritis. |
|
Scientific Title of Study
|
Changes in Autonomic Function and serum levels of inflammatory markers following guided deep breathing for a period of 6 weeks in the patients of rheumatoid arthritis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AUQIB RASHID |
| Designation |
Postgraduate Student |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Department of Physiology,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
| Phone |
7889321188 |
| Fax |
|
| Email |
auqib44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MADHULIKA MONGA |
| Designation |
DIRECTOR PROFESSOR DEPARTMENT OF PHYSIOLOGY LHMC & SSKH |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Department of Physiology,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 Department of Physiology,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 Central DELHI 110001 India |
| Phone |
7889321188 |
| Fax |
|
| Email |
madhulika.monga@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
AUQIB RASHID |
| Designation |
Postgraduate Student |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Department of Physiology,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central DELHI 110001 India |
| Phone |
7889321188 |
| Fax |
|
| Email |
auqib44@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College and SSKH |
| Address |
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
| 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 |
| AUQIB RASHID |
Lady Hardinge Medical College and SSKH |
Department of Rheumatology , LHMC. Central DELHI |
7889321188
auqib44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Lady hardinge medical college and assosiated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M04-M04||Autoinflammatory syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GUIDED DEEP BREATHING |
Guided deep breathing at 6 breaths per minute with 5 seconds each for inspiration and expiration for a peroid of 6 weeks is a simple, non-pharmacological intervention designed to enhance autonomic balance, reduce sympathetic overactivity, and promote parasympathetic (vagal) activation. Breathing at this slow, controlled rate aligns closely with the resonance frequency of the cardiovascular system, optimizing baroreflex function and improving heart rate variability (HRV). |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Men and women in the age group range from 18 to 60 years diagnosed with rheumatoid arthritis according to new 2010 ACR EULAR criteria. Those who are on stable medication for last 3 months. |
|
| ExclusionCriteria |
| Details |
Severe mental illness, chronic pulmonary illness, pregnant ladies, any cvd with lvef less than 30 percent, any drugs altering with autonomic nervous system. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in autonomic function parameters and serum levels of inflammatory markers (TNF alpha and CRP) after guided deep breathing for a period of 6 weeks in rheumatoid arthritis patients. |
At enrollment and after 6 weeks of guided deep breathing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients showing decrease in disease severity in rheumatoid arthritis patients after guided deep breathing for a period of 6 weeks.
Correlation between autonomic function parameters & serum levels of inflammatory markers (TNF alpha & CRP) with duration & severity of disease.
|
At baseline & after 6 weeks. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2027 |
| 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="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [auqib44@gmail.com].
- For how long will this data be available start date provided 12-09-2026 and end date provided 11-11-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Rheumatoid arthritis (RA) is a chronic autoimmune disease marked by joint inflammation, systemic complications, and increased morbidity and mortality. Growing evidence shows that RA patients often have autonomic nervous system imbalance, especially reduced parasympathetic activity and low heart rate variability (HRV), both linked to higher cardiovascular risk. Inflammation and autonomic dysfunction appear to interact through elevated cytokines and impaired vagal regulation. The vagus nerve plays a key anti-inflammatory role via the cholinergic anti-inflammatory pathway. Because of this, non-invasive methods that enhance vagal activity—such as deep breathing, yoga, and meditation—are being explored as adjunct therapies. Guided deep breathing, in particular, improves vagal tone and HRV through baroreflex activation and may help modulate inflammation and disease activity in RA. |