Therapeutic Evaluation of Hijamat-bish-Shart (Wet Cupping) in the treatment of Knee Osteoarthritis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index.
研究概览
简要总结
Osteoarthritis is a major cause of disability in both the developed and developing world. With the population aging, the prevalence of osteoarthritis is increasing and its consequences are impacting significantly on society. (Brooks, M, & Lund, 2002) Although the etiology of osteoarthritis is incompletely understood, the accompanying biochemical, structural, and metabolic changes in joint cartilage have been well documented. Pain and functional limitation are the primary clinical manifestations of osteoarthritis of the knee. Current recommendations for managing osteoarthritis, including guidelines published by the American College of Rheumatology and European League of Associations of Rheumatology, focus on relieving pain and stiffness and maintaining or improving physical function as important goals of therapy. Pharmacologic management of osteoarthritis is often ineffective, and agents such as NSAIDs may cause unwanted and dangerous side effects. Various modalities of alternative and complementary medicine are commonly used worldwide as an alternative to conventional therapy. Unani system of medicine can be the best alternative as it is rich therapy not only in the terms of pharmacological agents but also numerous modes of non-pharmacological means i.e., Regimenal therapy, with least or no known side effects. Keeping in view above facts, present study was designed and conducted to evaluate the efficacy of Hijamah (cupping) in the treatment of knee osteoarthritis and provide a safe and economical alternative. The study was conducted in the Majeedia Hospital and department of Ilaj-bit-Tadbeer (Regimenal therapy) of faculty of medicine, Jamia Hamdard, New Delhi. The study was randomized controlled trial with a sample size of 57. All the patients were enrolled with prior screening as per the guidelines of protocol. Almost all the patients were having bilateral knee osteoarthritis. Good Clinical Practice (GCP) guidelines were followed during the whole study. The duration of the study was 1 year and the duration of the protocol therapy was 6 weeks. Patients were randomly allocated into the test and control group. The patients in the test group were subjected to Hijamat-bish-Shart (wet cupping) on weekly basis while the patients in the control group were given Diclofenac gel for the local application to be used twice daily for the 28 days. The assessment of efficacy in the study was done with the outcome measures WOMAC Osteoarthritis Index LK3.1 (IK), visual analogue scale of pain (VAS) and active range of motion (AROM) that were recorded at the baseline, on the 28th day and at the end of treatment, i.e., 42nd day. To assess the safety of the intervention, hematological (hemogram with ESR) and biochemical parameters, including liver function test and kidney function test (KFT) were carried out pre and post intervention. The data was recorded and subjected to statistical analysis after the completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 38.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed according to American College of Rheumatology Criteria for Osteoarthritis.
- •Patients who discontinued all NSAIDS or other analgesic medication taken for any other condition, including their knee pain.
- •Patients signed the informed consent and follow the protocol voluntarily.
排除标准
- •Pregnancy and lactation
- •Uncontrolled Diabetes Mellitus
- •Patients with a past history of blood disorders
- •Patients participated in an experimental device, study or any clinical trial within the previous 30 days prior to screening
- •Any knee surgery in the previous three months
- •Other types of arthritis
- •Patients with any inter current disease(s) or condition(s) that may interfere with the completion of six week follow up—neurological problems, severe congenital defects, peptic ulcer, severe liver disease, severe coronary disease, hypertension, renal disease, abnormal mental state, or other clinically significant conditions
- •Patients on steroid therapy or NSAIDS.
- •Patients unable to understand WOMAC questionnaire form.
- •Patients allergic to topical diclofenac gel and with a history of gastritis.
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index.
时间窗: The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42.
Active range of motion.
时间窗: The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42.
Radiological assessment (Kellgren-Lawrence Radiographic Grading Scale of Osteoarthritis of the Tibiofemoral Joint, all Grades)
时间窗: The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42.
Visual analogue scale (VAS)
时间窗: The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42.
次要结局
- To provide safe alternative and economical treatment for knee osteoarthritis(To provide safe alternative and economical treatment for knee osteoarthritis)