Single arm Pilot study to test the efficacy of KECTS in advanced knee osteoarthritis.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the impact of KECTS on minimum Joint Space Width (mJSW) in persons with knee pain and Joint space narrowing with the help of Radiographs
研究概览
简要总结
The present study is the clinical study for osteoarthritis under sponsorship of TechClinic Connect Pvt. Ltd.,
Study type:-Open labelled single arm un-controlled study to test the efficacy of KECTS
Total - 20 patients
Duration - 3 months
Study center:- Dr. G. D. Pol Foundation YMT Ayurvedic Medical College and Hospital, Kharghar
Purpose of Study - Many patients having Knee pain associated with Joint space narrowing. Joint space narrowing occurs due to cartilage degeneration, wear and tear causing pain in the knees. The above cases gets cured by surgical interventions or injections at the site in modern practices but instead that we are offering treatment using herbo-mineral products orally and some external Panchkarma procedures locally at the site of knee
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1 Primary complaint of Knee pain- Unilateral or Bilateral, accompanied with Joint Space Narrowing OR cartilage loss and other associated symptoms.
- •Grade 3 and Grade 4 on Kellgren Lawrence OA classification.
- •Chronic knee pain- lasting for more than 3 months with Joint space narrowing at atleast one knee joint either medial/ lateral or both.
- •Willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- •Willing to abstain from other supplements or medication.
- •Ready to give voluntary, written, informed consent to participate in the study.
排除标准
- •Acute Knee pain due to Traumatic injury with fracture or ligament tear.
- •Persons diagnosed with Rheumatic arthritis, Polyarteritis Nodosa, Gout, Fibromyalgia, Scleroderma.
- •Persons with auto-immune disorders.
- •Persons with BMI greater than 34.
- •Persons diagnosed with AIDS, Hepatitis B, patients on ART.
- •Persons with congenital joint disorders.
- •Persons who are diagnosed with Pulmonary or extra pulmonary Tuberculosis, pleural effusion, COPD, Bronchial asthma, or severely compromised lung function.
- •Diagnosed with Hansen’s disease or any other infectious disease that needs immediate and long-duration treatment.
结局指标
主要结局
To assess the impact of KECTS on minimum Joint Space Width (mJSW) in persons with knee pain and Joint space narrowing with the help of Radiographs
时间窗: Day 1,21,42,60
次要结局
- 1. To assess the impact of the KECTS on Pain using assessment of(NPRS.)
研究者
Dr Kalpana Gholap
Dr G D Pol Foundation Y M T Ayurvedic Medical College and Hospital