A Randomized, Controlled, Double-Blind, Comparative Study to Evaluate the Effect of Sallapam Plus with or without low-dose serratiopeptidase in Patients with Rheumatoid Arthritis

Eutherva Medicament Pvt. Ltd1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2025年10月14日最近更新: 2025年12月30日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 24
试验地点: 1
主要终点: 1) Change in pain levels assessed by the Visual Analogue

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disorder characterized by persistent synovial inflammation, joint destruction, pain, fatigue, and significant functional impairment, affecting approximately 0.5-1% of the global population and imposing a substantial burden on quality of life and healthcare systems.this study aims to evaluate the clinical efficacy and safety of Sallapam Plus alone compared to Sallapam Plus combined with low-dose serratiopeptidase in patients with active RA over 90 days (3 months).Sallapam Plus is a proprietary, multi-ingredient herbal formulation traditionally marketed for musculoskeletal conditions such as arthritis, myalgia, and joint stiffness. Its composition typically includes Jatamansi (Nardostachys jatamansi) and Shallaki (Boswellia serrata), both of which have documented anti-inflammatory, antioxidant, and neuroprotective properties.The investigational use of Sallapam Plus, with or without low-dose serratiopeptidase, is expected to offer several potential benefits to patients with RA, particularly in reducing joint pain, improving sleep quality, enhancing cognitive function, and alleviating systemic inflammation through its herbal and enzymatic mechanisms.

The treatment continues for a period of three months (90 days). The total duration of the study is 12 months.

In this study 24 participants—12 in each treatment arm—has been chosen to allow for a comparative evaluation of clinical trends, feasibility of study procedures, and potential therapeutic signals.

The schedule of assessment for this study spans a duration of 90 days and comprises two site visits: the screening visit (V1), baseline visit (V2) and end-of-study visit (V4). Additionally, subjects will undergo periodic telephone follow-ups throughout the treatment period to monitor their progress and product compliance.

Participants will complete VAS, AIS, FCT, DAS28 and SF-36 Quality of Life assessments, along with SGA and PGA scores in screening and end of visit. Blood samples will be drawn for Screening and End of visit: serum TAC, CRP, ESR, cortisol and fibrinogen as well as safety parameters including CBC, SGPT, SGOT, and Sr. creatinine. Adverse events reported throughout the study will be reviewed, and participants will return any unused medication.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 20.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Male and female participants aged over 20-65 years 2) Participants have been diagnosed with rheumatoid arthritis by a general practitioner and or orthopedic physician or surgeon according to the 2010 American College of Rheumatology 168 (ACR).
•Able to evaluate disease activity by themselves.
•Participants who have no plans to start new treatments during the study period 5) Patients who require anti-inflammatory treatment, do not use anti-inflammatory analgesic medications on a regular basis, or are unsatisfied with their treatments and want to alter them.
•Patients ready to give written informed consent and willing to comply the study protocol.

排除标准

•Participants using other complementary and alternative medicine or any addiction to psychotropic agents and opioids.
•Participants with uncontrolled medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, gallbladder disease, renal disease, endocrine disease, or malignancies, neurological diseases, or psychiatric conditions.
•Patients with concurrent rheumatoid diseases and gout.
•Use of biologic agent therapy in the last 6 months.
•Participation in any other clinical trial within 30 days of screening.
•Any history of allergy to any of the drugs investigational products.
•Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures.