Evaluation of efficacy and safety of DimÄd-e-Asfar in the Management of Knee Osteoarthritis (Waja’al-Rukba)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1) WOMAC Index
研究概览
简要总结
Osteoarthritis is the most common degenerative joint disease and a major cause of pain and disability in adult individuals.This degenerative and progressive joint disease affects around 250 million people worldwide. Osteoarthritis is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Knee osteoarthritis is classified as either primary (idiopathic) or secondary. Major risk factors or etiologies of osteoarthritis are advancing age, female sex, past trauma, obesity, sport injury, inflammation, genetic predisposition and nutritional deficiency etc. Common clinical symptoms include chronic pain, joint instability, stiffness and radiographic joint space narrowing.
| The standard pharmacological | |
| treatment includes agents to control pain and inflammation (NSAIDs, | |
| analgesics including opioids, intraarticular corticosteroids) and the group | |
| of symptomatic slow acting drugs for osteoarthritis such as glucosamine | |
| sulphate, chondroitin sulphate, diacerein, unsaponifiable extract of soyabean | |
| and avocado administered orally as well as intraarticular hyaluronic acid | |
| administration. |
| The aim of the management of |
| osteoarthritis is to control the painful signals originated from these |
| joints, but even more, to improve physical function and quality of life. Non |
| pharmacological therapies should always be attempted as the first line of treatment |
| for knee osteoarthritis. |
In Unani system of medicine, the term Knee osteoarthritis is not mentioned as such, however, a general term “Waja’al-MafÄsil†exists in classical text, which includes all types of arthritis. Ancient unani physicians have classified it on the basis of temperament, presence or absence of morbid material, type of morbid material involved and site of manifestations etc.Waja’al-Rukba (knee pain) is also used for the arthritis of knee as “Waja†stands for pain and “Rukba†stands for knee. So, the osteoarthritis of knee is treated on the line of treatment of Waja’al- MafÄsil described in Unani literature. There are three modes of treatment in unani system of medicine; IlÄj-bit-TadbÄ“r wa Taghzia, IlÄj-bil-Dawa and IlÄj-bil-yad. IlÄj-bit-Tadbeer includes various non-pharmacological or least pharmacological modalities which lack scientific validation in certain disorders. Among the various IBT interventions DimÄ**d (Application of medicated paste topically) has been used by our ancient physicians in the management of different painful musculoskeletal disorders.DimÄ**d-e- Asfar is mentioned in our literature to treat these painful/inflammatory disorders as having anti-inflammatory and analgesic effects but scientific validation is still to be done on its efficacy. Furthermore, no adverse effect is documented too about this topical formulation. Hence, this study is planned to validate its efficacy and safety in the management of Knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fulfilling the inclusion criteria and agree to follow the protocol 2) Diagnosed cases according to American College of Rheumatology Criteria of Osteoarthritis and classified as grade II or III for OA of the knee according to Kellgren Lawrence Grading system 3) Patients with symptoms consistent with Osteoarthritis of the knee for at least six months prior to screening These symptoms include joint pain and also include crepitus swelling and/or effusion of the knee 4) At screening patients on any analgesic/anti-inflammatory medication shall be screened on visual analog scale (VAS) of pain after walking on a 50 ft flat surface of greater than 30 mm but lesser than 90 mm using a 100 mm scale If patients taking no analgesic/anti-inflammatory medication in the previous 3 days from screening then they should have VAS pain score after walking on a 50 ft flat surface of greater 40 mm but lesser 90 mm If bilateral knee pain is present the more painful knee will be selected 5) At screening and baseline if there will be bilateral OA of the knee involvement patients must have a VAS pain score after walking on a 50 ft flat surface of lesser than 30 mm in the less painful contralateral knee at the baseline assessment 6) Patient who can perform the 50-feet walk test without the support of crutches or other assistive devices 7) Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition including their knee pain.
排除标准
- •Patients participating in an experimental device study or any clinical trial within the previous 30 days prior to screening 2) Any knee surgery in the previous three months 3) Patient with Kellgren-Lawrence Grade I and grade IV OA of the knee 4) Other types of arthritis 5) Patients with any inter current disease (s) or condition (s) that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the completion of the 4 week follow up (neurological problems, severe congenital defects, peptic ulcer, severe liver disease, severe coronary disease, renal disease, Active Psychiatric disorder, or other clinically significant conditions).
结局指标
主要结局
1) WOMAC Index
时间窗: Baseline, 7th day, 14th day, 21th day, 28th day
2) Active Range of Motion /AROM
时间窗: Baseline, 7th day, 14th day, 21th day, 28th day
3) Eight-meter walk test
时间窗: Baseline, 7th day, 14th day, 21th day, 28th day
次要结局
- Quality of life(Baseline and 28th day)
研究者
Almas Furquan
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital