A randomized, double blind, placebo controlled clinical study to evaluate the efficacy & safety of the investigational product in rheumatoid arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- 1. Assessment of disease activity score (DAS-28)
研究概览
简要总结
RA is a chronic disease that has multiple and fluctuating symptoms. Because no one measure can adequately capture disease activity or severity.
Proteolytic enzymes in RA are grounded in their observed anti-inflammatory properties, which can potentially mitigate the chronic inflammation characteristic of RA joints. These enzymes, such as bromelain, papain, trypsin, and chymotrypsin, may modulate inflammatory pathways by degrading cytokines and other inflammatory mediators. Additionally, they show promise in promoting tissue repair and regeneration, essential for combating joint damage and erosion in RA. Studies suggest that proteolytic enzymes could help restore immune balance by influencing cytokine profiles and immune cell function. Clinical evidence supports their role in reducing pain and improving joint function, offering a complementary therapeutic approach alongside conventional RA treatments.
This trial is also designed to investigate whether oral proteolytic enzymes could provide systemic relief from gastrointestinal symptoms, which are commonly associated with the DMARDs. Specifically, the study aimed to assess the enzymes’ potential in alleviating heartburn, gastric discomfort, and epigastric pain in individuals with rheumatoid arthritis, offering a potentially safer alternative or adjunct to conventional DMARD therapy.
Moreover, their natural origin often ensures better tolerability and safety profiles compared to synthetic medications, making them appealing for participants seeking alternative or adjunctive therapies for RA management. The aim of the study was to evaluate the efficacy and safety of an oral enzyme supplement (EnMax DS) with the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants 30-60 years of age (both inclusive), who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria;2.Mild to moderate disease activity, according to DAS 28 (Erythrocyte Sedimentation Rate ESR) greater than an equal to 3.2;
- •Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than an equal to 6 weeks;
- •Participant on stable medication that is DMARDs that is methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine greater than an equal to 3 months for RA;
- •Participants having VAS score in between 4 to 8;
- •Willing to give informed consent for the study.
排除标准
- •Participants with other systemic complications of RA like rheumatic heart disease (RHD), rheumatic fever, pleural pericardial disease;
- •Participants diagnosed with other arthritis like gouty arthritis, and tuberculous arthritis.
- •However, participants with radiologically confirmed osteoarthritis may be excluded at the investigators discretion if the severity of OA is judged to interfere with the study assessment;
- •Allergy, sensitivity, or contraindication to interventional product; 4.Participants receiving anticoagulant and or antiplatelet agents; 5.Participants who are unable to walk without support and or confined to a wheelchair; 6.Past history of TNF (tumor necrosis factor) blocking agents or other biologic treatment; 7.Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results; 8.History of psychiatric disorder that may impair the ability of participant to provide written informed consent; 9.A history presenting RA encompassing more than a year; 10.Participation in any RA related or any other trials involving investigational products within 30 days prior to the screening visit; 11.Participants treated with any investigational drug in the preceding 4 weeks; 12.Female participants with a positive pregnancy test or lactating; 13.History of drug abuse or dependence; 14.History of septic arthritis within a native joint within the last 12 months; 15.Presence of a transplanted organ; 16.Participants unable to comply with the treatment regimen; 17.Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA; 18.Participants with any other condition that, in the opinion of the investigator, does not justify the inclusion of the participant in the study.
结局指标
主要结局
1. Assessment of disease activity score (DAS-28)
时间窗: 1. At screening, day 1, day 15, day 30, and day 45. | 2. At screening, day 1, day 15, day 30, and day 45. | 3. At day 1, day 15, day 30 and day 45.
2. Changes in Visual Analogue Scale (VAS) pain score
时间窗: 1. At screening, day 1, day 15, day 30, and day 45. | 2. At screening, day 1, day 15, day 30, and day 45. | 3. At day 1, day 15, day 30 and day 45.
3. Assessment of changes in the duration of the morning stiffness (minutes)
时间窗: 1. At screening, day 1, day 15, day 30, and day 45. | 2. At screening, day 1, day 15, day 30, and day 45. | 3. At day 1, day 15, day 30 and day 45.
次要结局
- 1. Changes in biomarkers such as TNF-Alpha, IL-1, IL-6, hsCRP, MMP 3, ESR(2. Changes in physician’s global assessment score)
研究者
Dr Ameya Pathak
Sangvi Multispeciality Hospital Pvt. Ltd.