CTRI/2021/08/036008尚未招募2 期
A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Habb-i Dard-i Mafasil in Wajaâ?? al-MafÄ?á¹£il (Osteoarthritis)
ational research institute of Unani medicine for skin disorders0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participants of any gender aged between 40 and 65 years
- •2. Clinical and Radiographic Knee Osteoarthritis as per the following
- •American College of Rheumatology (ACR) criteria:
- •a. Knee Pain
- •b. Osteophytes on Knee Radiograph, and
- •c. At least 1 of the following 3 criteria:
- •i. Age >=40 years (revised as per Sl. No. 1)
- •ii. Morning Stiffness lasting <=30 minutes
- •iii. Crepitus on Active Knee Motion
- •3. Knee OA of Kellgren-Lawrence Grade 1 to 3
- •4. Body Mass Index (BMI): <40 kg/m2
- •5. Willing to come for regular follow-up visits for entire duration of the study
- •6. Ability to provide Written Informed Consen
排除标准
- •1. Age <40 years and >65 years
- •2. Knee OA of Kellgren-Lawrence grade IV
- •3. BMI >=40
- •4. Patients with Knee Joint Effusion
- •5. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing
- •spondylitis, psoriatic arthritis, gout), or any other type of arthritis
- •6. Patients on long-term steroid treatment
- •7. H/o having received intra-articular knee injection (corticosteroids or
- •hyaluronan), or any investigational drug in the previous one month
- •8. Any significant systemic diseases (cardiovascular, gastrointestinal,
- •hepatic, renal, neurologic or psychiatric disorder)
- •9. Known hypersensitivity to study drug or any of its ingredients
- •10.Pregnant and lactating women
- •11.H/o addiction (alcohol, drugs)
- •12.Unwilling to come for regular follow-up for entire duration of the study
- •13.Patients considered not eligible in the Investigatorâ??s opinion during the
研究者
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