A Randomized, Active-Controlled, Assessor-Blinded, Parallel Group Clinical Study to evaluate the safety and efficacy of Qurs-e-Mafasil in the Management of Waja‘al-MafÄá¹£il (Rheumatoid Arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters:
研究概览
简要总结
Rheumatoidarthritis(RA) is a chronic inflammatory disease of unknown etiologycharacterized by a symmetric polyarthritis, the most common form of chronicinflammatory arthritis.Since persistently active RA often result in articularcartilage and bone destruction and functional disability,it is vital todiagnose and treat thisdisease early aggressively before damageensues.1
Theincidence of RA increases between 25 and 55 years of age, after which itplateaus until the age of 75 and then decreases.1The prevalence ofRA is approximately 0.8-1% in Europe and the IndianSubcontinent,with a femaleto male ratio of 3:1.2Rheumatoid arthritis(RA) is an autoimmunedisease with a worldwide prevalence of approximately 0.5 to 1% among adults.3
When RAis left uncontrolled, the patient may experience joint deterioration, severedisability, decreased quality of life, the onset of comorbidities and prematuremortality.The potential comorbidities include but are not limited tocardiovascular disease(CVD), cancer(specifically lymphoma and lympho-proliferativediseases, lung cancer and melanoma), infections, depression andgastrointestinal disease.3
In Unanisystem of medicine,Arthritis is described under broad termWaja‘al-MafÄá¹£ilwhich include entire joint disorders like inflammatory, non-inflammatory,infectious,metabolic and other joint disorders.4
Populationstudies and WHO statistic indicate that 10-50% of individuals suffer from musculoskeletaldisorders and almost all patients require non- steroidal anti-inflammatorydrugs(NSAIDs) and other analgesic for their management. The large majority ofthis population is elderly and hence, greater risk of adverse effects,Including gastritis, peptic ulcer and renal impairment.5 Disease-modifyinganti-rheumatic drugs(DMARDs) act by altering the underlying disease rather thantreating symptoms however some of the DMARDs use for the treatment of RA areassociated with pulmonary toxicity,cardiactoxicity, irreversible retinaldamage,hepatotoxicity, myelosuppression and reactivation of latent TB andincreased risk of all types of infection including fungal infection by TNF-αinhibitors. Chronic use of Glucocorticoids in treatment of RA can cause osteoporosis and other long-termcomplication.1
Despite of wide range of treatment available in conventional system ofmedicine, there is no cure of rheumatoid arthritis although Unani system ofmedicine provide a number of single as well as compound formulations which arein use since ancient time but these formulations have to be evaluated onscientific parameters in order to generate data regarding their safety andefficacy.Therefore, the present clinical study has been planned to evaluate thesafety and efficacy of Qurs-e-Mafasilinthe treatment of Waja‘al-MafÄá¹£il(Rheumatoid arthritis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of any sex in the age group 35-55 years Patients diagnosed with Waja‘al-MafÄá¹£il (Rheumatoid arthritis) on the basis of following ACR-EULAR criteria 1)Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 2)Absence of an alternative diagnosis for the observed synovitis (arthritis) 3)Achievement of a total score of 6 or greater(of a possible 10) from the individual scores in 4 domains: a)Number and site of involved joints(range 0-5) b)Serological abnormalities (range 0-3) c)Elevated acute phase reactants (range 0-1) d)Duration of symptoms (range 0-1).
排除标准
- •Patients aged <35 years or >55 years Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse) History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy,IBD , psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation Currently receiving or have intra-articular treatment (e.g. corticosteroids, or NSAIDS within 2 weeks of study entry and DMARDs or IFN therapy within 4 wks prior to study entry or are anticipated to require IFN therapy during study History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment History of hypersensitivity to study drug or any of its ingredients Pregnant or Lactating Women Hypertensive and Obese Subjects (BMI≥30) H/o Addiction (alcohol, drugs) Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies Patient not willing to attend treatment schedule regularly.
结局指标
主要结局
Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters:
时间窗: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: | 1) Visual Analogue Scale (VAS) | 2) Disease Activity Score in 28 joints (DAS28)27
2) Disease Activity Score in 28 joints (DAS28)27
时间窗: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: | 1) Visual Analogue Scale (VAS) | 2) Disease Activity Score in 28 joints (DAS28)27
1) Visual Analogue Scale (VAS)
时间窗: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: | 1) Visual Analogue Scale (VAS) | 2) Disease Activity Score in 28 joints (DAS28)27
次要结局
- Lab investigation and X-ray(0,2, 4 weeks)