Evaluation of The Individual and Combined Effect of Mritika Lepa and oral Ayurveda Drugs on Pain Alleviation and Modulation of Inflammatory Markers in Rheumatoid Arthritis A Pilot Clinical Study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured using a standardized pain scale
研究概览
简要总结
Need of study
• Rheumatoid Arthritis is one of the leading problems in middle aged group in the world. The prevalence of Rheumatoid arthritis worldwide is 0.5 to 1% of total population. In India there is about 1.3 crore patients in 2021 according to various studies. So, this is the leading health problem world-wide and also in India that affects the normal functions of people.
• No satisfactory management of RA has found till now in contemporary sciences. Many studies related to the Rheumatoid Arthritis has been conducted in the field of Ayurveda. Many successful Ayurvedic treatment procedures and protocols are also established.
• There are many Lepas developed for Rheumatoid Arthritis. All these treatments procedures are relatively complex, many needing hospitalization and are a bit expensive as compared to Mritika Chikitsa. Hypothesis behind the planning of this research work is to provide an alternative treatment procedure to the patients.
• So, this study is planned as an attempt to evaluate the effect of Mritika Chikitsa in Rheumatoid Arthritis that is relatively less expensive, less complicated, needs no hospitalization and is easily available.
• Aim: To evaluate the effect of Mritika Chikitsa in Rheumatoid Arthritis.The aim of this study is to assess and compare the pain alleviating and inflammatory markers modulating effects in patients with Rheumatoid Arthritis who receive therapy with oral Ayurveda drugs alone, Mritika Lepa alone, and the combination of oral Ayurveda drugs and Mritika Lepa.
• Objective**:**
1.To evaluate the efficacy of oral Ayurveda drugs (Rasnasaptak kwath and singhanad guggulu) in providing pain relief and modulating inflammatory markers in patients with Rheumatoid Arthritis.
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To assess the efficacy of Mritika Lepa in alleviating pain and modulating inflammatory markers in patients with Rheumatoid Arthritis.
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To investigate the combined efficacy of Oral Ayurveda drugs and Mritika Lepa on pain alleviation and modulation of inflammatory markers in patients with Rheumatoid Arthritis.
4.To compare the individual and combined therapies to identify potential synergistic effects for pain relief and inflammatory marker modulation in Rheumatoid Arthritis.
- To provide preliminary evidence for guiding future larger-scale clinical trials and treatment recommend
Research Question : Inflammations for Rheumatoid Arthritis management.
**Null Hypothesis:**H0 - There is no difference in pain alleviation and modulation of inflammatory markers among patients with Rheumatoid Arthritis who receive therapy with Oral Ayurveda drugs alone, Mritika Lepa alone, and the combination of Oral Ayurveda drugs and Mritika Lepa.
STUDY DESIGN : 60 patients with 20 patients in each group.
• Total duration of study: 18 MONTHS
• Recruitment period: 12 MONTHS
• Treatment period: 02 WEEKS
• Follow up: EVERY WEEK (During Treatment)
• Type of study: Interventional
• Intervention and comparator agent :
• Group A: Rasna saptak kwath 40 ml twice a day in morning and evening at empty stomach along with sinhanada guggulu 2 tab each of 500 mg twice a day in morning and evening for 2 weeks
• Group B: Mritika Lepa on affected joints with pain, stiffness and inflammation once a day in morning at empty stomach for 20-30 minutes for 2 weeks
• Group C: Both above treatments for 2 weeks
• Reference – Madhava nidana , amavatanidan, 1-6, chapter 25
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 60 years of either sex Confirmed and diagnosed cases of Rheumatoid Arthritis based on established criteria e g American College of Rheumatology/European League Against Rheumatism criteria Active disease status as indicated by a Disease Activity Score DAS28 of more than or equal to 3 point 2 Chronic cases up to 5 years.
排除标准
- •Pregnant or lactating individuals due to potential risks associated with the treatments Known contraindications or allergy to any of the study drugs contents or Mritika Lepa Presence of significant comorbidities such as uncontrolled diabetes hypertension renal or hepatic impairment which may interfere with the assessment of study outcomes Coexistence of other autoimmune diseases e g systemic lupus erythematosus that may confound the assessment of Rheumatoid Arthritis outcomes Severe joint damage or deformities that may limit accurate pain assessment or interfere with the treatment outcomes Use of systemic immunosuppressive agents within the last three months prior to enrolment Recent major surgery within the last three months that may impact the study outcomes Participation in another clinical trial within 30 days before screening Inability to comply with the study procedures or follow-up visits.
结局指标
主要结局
Change in pain intensity measured using a standardized pain scale
时间窗: Change in pain intensity measured using a standardized pain scale in two weeks
次要结局
- 1 Changes in inflammatory biomarker levels like C reactive protein erythrocyte sedimentation rate and complete blood count(2 Improvement in functional status using disease specific assessment tools DAS 28 Score for Rheumatoid Arthritis)
研究者
Dr Durgawati Devi
National Institute of Ayurveda