To Evaluate the therapeutic efficacy of Habb-e-Asgand in the management of Waja-ul-Mafasil(Rheumatoid Arthritis).A Randomized, Single blind, Standard Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of Rheumatoid arthritis
研究概览
简要总结
Rheumatoid Arthritis (Waja-ul-Mafasil) is a common,immune-mediated disease characterized by chronically progressive inflammationand destruction of joints and associated structures as well as systemicsymptoms .Rheumatoid arthritis is one of the most commondiseases in India. The population prevalence of rheumatoid arthritis in Indiais 0.75%. It was estimated that 9 million people could be affected with Rheumatoidarthritis.
Peak incidence are in 3rd to 4th decades oflife, with 3-5 times higher preponderance in females. The onset of the diseaseis insidious, beginning with prodrome of fatigue, weakness, joint stiffness,vague arthralgias and myalgias. This is followed by pain and swelling of jointsusually in symmetrical fashion, especially involving joints of hands, wrist andfeet. Approximately 20% of patients develop rheumatoid nodules located over theextensor surfaces of the elbows and fingers.
The mortality rate is higher amongpatients with RA than among healthy persons, and cardiovascular and othersystemic complication remain a major challenge.
Current therapy has a goal ofcomplete and long-lasting remission but, typically, only partial remission isachieved and frequent relapses or even non-response are common.
Conventional treatments for RA, includingnon steroidal anti-inflammatory drugs (NSAIDs), slow-acting anti-rheumaticdrugs and corticosteroids, aim to reduce the patients’ pain and jointinflammation, minimize loss of function and decrease the progression of jointdamage. However, such treatments are rarely totally effective and somepharmacological therapies have the potential to cause side-effects, such asgastro-intestinal bleeding and bone loss.5 As a result manyRA sufferers turn to alternative therapies including Unani system ofmedicine. Habb-e-Asgand is an important Unani pharmacopoeialformulation which is commonly prescribed for W**aja-ul-Mafasil(Arthritis) and Waja-ul-Warik (Lumbago) due to its Muhallil-e-Waram(anti-inflammatory)action**.6,7**Hence, the need arise to validate the action ofthis compound in the management of Waja-ul-mafasil (Rheumatoidarthritis) keeping in view the line of treatment Waja-ul-mafasil Balgami(phelgmatic arthritis).The current study is therefore designed to investigatethe effect of Habb-e-Asgand in Waja-ul-mafasil(Rheumatoid Arthritis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Clinically diagnosed /or serological evidence of Rheumatoid arthritis(Waja-ul-Mafasil).
- •2 Patients who have agreed to sign the informed consent, follow the protocol and willing to participate in clinical trial voluntarily.3 Mild to Moderate cases of Rheumatoid Arthritis.4 Have a diagnosis of Rheumatoid Arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR)2010 Criteria for the Classification of RA.
排除标准
- •Uncontrolled Diabetes mellitus.
- •Hepatic or Renal insufficiency.
- •Other type of arthritis.
- •Pregnancy and lactation.
- •Any joint surgery in the previous 6 months
- •Patients with cardiovascular diseases.
- •Patients who refuse to give the written consent for the study.
- •Severe cases of Rheumatoid Arthritis.
结局指标
主要结局
Relief in signs and symptoms of Rheumatoid arthritis
时间窗: 45 days
次要结局
- Haematological, Radiological and Biochemical assessment(45 days)