Effectiveness of yoga intervention on the levels of autoantibodies, inflammatory epigenetic markers and quality of life in women with systemic lupus erythematous.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
时间窗: All the above parameters are measured at baseline and again at the end of intervention period i.e after 6 months.
Micro RNA
时间窗: All the above parameters are measured at baseline and again at the end of intervention period i.e after 6 months.
次要结局
未报告次要终点