Comparative Evaluation Of Efficacy Of The Unani Polyherbal Formulation And Habb Suranjan In Waja Al Mafasil(Knee Osteoarthritis)-A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of the Unani test drug with the well-validated WOMAC CRD
研究概览
简要总结
Waja al Mafasil Osteoarthritis is acomprehensive term that is applied to a variety of joint pain. The term iscommonly employed for joint pain. It encompasses all kinds of joint pain suchas Niqris (gout) Waja ul Warik (ischial pain) Irq al nisa (sciatica)Waja ur Rakba(Knee Osteoarthritis) etc.Osteoarthritis is a degenerative joint disease. Itproduces pain, swelling, and stiffness, affecting a persons ability to movefreely. It affects the entire joint, including the tissues around it. It ismost common in the knees, hips, spine, and hands. Obesity, advanced age, andprolonged, joint use are risk factors for this illness. Pain, stiffness, andlack of movement are how they are clinically represented. It contributes tochronic pain, disability, and reduced quality of life. The WHO estimated around355 million people worldwide suffer from osteoarthritis, and by 2040, itsexpected to influence even 25% of the population. In India, OA is the 2nd mostcommon problem and most frequently occurring joint disease with a prevalence of22% to 39%. Conservative management for knee OA includes NSAIDs (Non-Steroidal Anti-inflammatorydrugs) Corticosteroid injections physiotherapy Acupuncture and Weight reductionmanagement, surgery to repair the joint, and lastly joint replacement. Despiteconventional treatment, OA is often progressive and frequently leads to chronicpain and disability and develops side effects. It is the most common jointdisease worldwide, affecting an estimated 10% of men and 18% of women over 60years of age. As per the humoral concept of Unani medicine, it may be caused bySu-i-Mizaj Sada and Su I Mizaj Maddi (morbid temperament) due to abnormalAkhlat (morbid humour) involvement. In the Unani system of medicine, the mainprinciples of treatment include Ilaj BilTaghdiya (Dietotherapy), Ilaj bil Tadbeer (Regimenal therapy), and Ilaj bilDawa (Pharmacotherapy). All the said principles are recommended for thetreatment of Waja-al Mafasil. Variations in the principles and management ofdifferent types of Waja-al-Mafasil differ. Preventing morbidity and disabilityis the primary objective of the treatment of patients with waja al mafasil. InIlaj Bil dawa(pharmacotherapy) several single drugs such as suranjan Shirin(Colchicum autumnale), bozidan (pyrethrum indicum), zanjabeel (zingiberofficinalis) anisoon (Pimpinella anisum), etc and in compound majoon suranjanand majoon ushba are us
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Radiological changes as per grades I to IV of the Kellgren and Lawrence Radiological scale.
- •Patients of OA Knee Joint as per ACR Criteria The presence of knee pain with at least one of the following three items along with osteophyte in knee X-ray can classify the knee OA in the patients 30 years and above Morning stiffness less than 30 minutes Crepitus on knee motion.
- •Willing to comply with the protocol.
排除标准
- •Participants age below 30 years and above 65 years.
- •Intervention concerning History of any Trauma/Fractured joint/Surgical/Knee replacement/intra articular injections.
- •Any unstable cardiovascular disease, chronic systemic illness, and any evidence of malignancy.
- •Other types of osteoarthritis Rheumatoid arthritis, etc.
- •Pregnant and lactating women.
- •Mentally unstable patients.
- •Participants who are currently participating in any other clinical trial.
结局指标
主要结局
To assess the efficacy of the Unani test drug with the well-validated WOMAC CRD
时间窗: Baseline, 1st week ,2nd week, 4thweek , 6th week
PUNE and VAS scale.
时间窗: Baseline, 1st week ,2nd week, 4thweek , 6th week
次要结局
- Improvement in QOL with WOMAC(Modified)CRD PUNE in OA patients from(baseline to 6 weeks.)