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CTRI Number  CTRI/2021/05/033419 [Registered on: 06/05/2021] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga intervention for patients with systemic Lupus erythematous  
Scientific Title of Study   Effectiveness of yoga intervention on the levels of autoantibodies, inflammatory epigenetic markers and quality of life in women with systemic lupus erythematous. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shobana 
Designation  Demonstrator 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Department of physiology Sri Ramachandra Medical College and Research Institute porur chennai

Chennai
TAMIL NADU
600116
India 
Phone  09840012288  
Fax    
Email  shobana.r@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobana 
Designation  Demonstrator 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Department of physiology Sri Ramachandra Medical College and Research Institute porur chennai

Chennai
TAMIL NADU
600116
India 
Phone  09840012288  
Fax    
Email  shobana.r@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Shobana 
Designation  Demonstrator 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Department of physiology Sri Ramachandra Medical College and Research Institute porur chennai

Chennai
TAMIL NADU
600116
India 
Phone  09840012288  
Fax    
Email  shobana.r@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Study will be conducted in department of Physiology, Sri Ramachandra Medical college and Hospital, chennai, Tamilnadu. 
 
Primary Sponsor  
Name  Dr Shobana 
Address  Department of Physiolog SRMC & RI Porur 
Type of Sponsor  Other [Self funded ] 
 
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 
DrShobana   Sri Ramachandra Medical college andreserach institute  Second floor, Department of physiology, Department of Biochemistry, Department of General Medicine Sri Ramachandra Medical College and Research Institute, porur, chennai.
Chennai
TAMIL NADU 		 9840012288

shobana.r@sriramachandra.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Control Group will follow the routine treatments  
Intervention  YOGA  A specific Yoga module by Middleton KR et al, 2018 for Systemic Lupus Erythematous will be used in this study. Video of yoga session recorded by experts will be shared among the participants in intervention group. The participants of yoga group will do recorded yoga sessions weekly five times and send it to us for assessment. Each session last about 60 min consisting of breathing techniques, meditation & relaxation pose. The yoga module is a simple & controlled breathing exercise cause no harm to participants with complications. Complete yoga program schedule is explained in the table below. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  New cases- All SLE patients fulfill the revised ACR classification criteria
malar and discoid rash, photosensitivity, oral ulcers, arthritis, serositis, renal, neurological, hematologic and immunologic disorder, and positive antinuclear antibody.
The presence of 4 out of 11 criteria is confirmed to be the diagnosis of SLE.
Resistant case- SLE patients unresponsive to previous treatment with one/ more successive/ simultaneous conventional immunosuppressive drugs for more than 6 months or had continuing requirement for a daily dose of ≥20 mg of steroids or its equivalent
 
 
ExclusionCriteria 
Details  Patients with severe form of SLE
 ▪ Patients with any other Inflammatory disorder & immune deficiency disorder.
 ▪ Patients with confirmed HIV infection
 ▪ Patients with acute infectious diseases & metastatic diseases
 ▪ Patients with Associated co-morbidity or depression or psychological illnesses
 ▪ Practicing yoga in the past 3 months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Routine markers- Hb, WBC, DC, ESR, Urine R/E (preferably a fresh sample examined), Serum chemistry (urea, creatinine, liver function tests, lipid profile), Autoantibodies and complement- ANA, anti-dsDNA, anti-cardiolipin, C3, C4, Inflammatory markers: IL-6, IL-10, IL-17, TNF-alpha, Interferon-gamma
Micro RNA 		 All the above parameters are measured at baseline and again at the end of intervention period i.e after 6 months.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   15/05/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Yoga intervention for Patients with Systemic Lupus erythematous - A Research Protocol. Paper submitted to a journal for publication. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Randomized control interventional study is planned to evaluate the effectiveness of yoga intervention on clinical manifestations & molecular level among Systemic lupus erythematous participants. IEC approval is obtained from the institution. 128 Systemic lupus erythematous participants are identified based on revised ACR classification criteria and they are grouped as newly identified cases (n – 64) and treatment resistant cases (n – 64). In each group, 32 participants will be subjected to yoga intervention for 6 months along with standard treatment, while the rest 32 individuals will follow standard therapy for SLE.  Yoga intervention is given for 45-60 minutes weekly three times as direct contact session and rest of two class as home- based session using the video handout provided to them. This intervention is continued for 6months duration. Parameters like complete blood routine markers (Hb, WBC, DC, ESR, urea, creatinine, liver function tests, lipid profile), Autoantibodies for ANA, anti-dsDNA, anti-cardiolipin and complement, Inflammatory markers (IL-6, IL-10, IL-17, TNF-alpha, Interferon), microRNAs will be checked in all the groups before and after implementation of yoga. The quality of life is assessed in each group using Lupus-QoL questionnaire. The parameters will be compared between interventional & non-interventional group for improvement in the markers & also in quality of life.

 
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