Yoga intervention for patients with systemic Lupus erythematous

Recruiting

• Conditions: Other specified metabolic disorders,

• Registration Number: CTRI/2021/05/033419
• Lead Sponsor: Dr Shobana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-15
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with severe form of SLE ï¶â–ª Patients with any other Inflammatory disorder & immune deficiency disorder.
• ï¶â–ª Patients with confirmed HIV infection ï¶â–ª Patients with acute infectious diseases & metastatic diseases ï¶â–ª Patients with Associated co-morbidity or depression or psychological illnesses ï¶â–ª Practicing yoga in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	All the above parameters are measured at baseline and again at the end of intervention period i.e after 6 months.
Micro RNA	All the above parameters are measured at baseline and again at the end of intervention period i.e after 6 months.

Trial Locations

Locations (1)

Sri Ramachandra Medical college andreserach institute; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Medical college andreserach institute

🇮🇳Chennai, TAMIL NADU, India

DrShobana

Principal investigator

9840012288

shobana.r@sriramachandra.edu.in