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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  
nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [auqib44@gmail.com].

  6. 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.

  7. 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.
 
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