CTRI/2017/12/010899
已完成
2 期
A prospective clinical, double-blind, placebo controlled, randomized, phase 2 study-to compare the efficacy and safety of KAL-13 in treating the signs and symptoms of osteoarthritis in the knee and/or hip.
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: null- Osteoarthritis of Knee and/or HipHealth Condition 2: M179- Osteoarthritis of knee, unspecified
- 发起方
- Kerala Ayurveda Limited
- 入组人数
- 150
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. History of osteoarthritis of the knee characterized by pain of mild or moderate intensity.
- •2\. Presence of persistent knee pain for at least 1 preceding month preceding the study.
- •3\. Require treatment with either analgesic or anti\-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
- •4\. Diagnosis of osteoarthritis of the hip or knee
- •5\. Diagnosis of hip OA: having hip pain and meeting criteria for at least 2 of the following:
- •5a) Westergren erythrocyte sedimentation rate of less than 20 mm/hr
- •5b)Radiographic femoral or acetabular osteophytes or
- •5c)Radiographic joint space narrowing
- •6\. Diagnosis of knee OA: Diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus with at least one of the following:
- •6a)Age greater than 50 years
排除标准
- •1\. History of surgery , including arthroscopy, or major trauma to the study joint in the previous 12 months.
- •2\. Radiographic evidence of severe osteoarthritis of the study joint based on the kellergen and Lawrence radiographic criteria of grade 4 osteoarthritis
- •3\. Signs of active study joint inflammation including redness, warmth, and/or if qualifying with osteoarthritis of knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.
- •4\. Morning stiffness of \>30 minutes duration.
- •5\. Significantly incapacitated or disabled and would be categorized as ACR functional class III (able to perform only few or none of the duties of usual occupation or self\-care) or IV (largely or wholly incapacitated) or unable to walk without assistive devices
- •6\. History of Joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial.
- •7\. Significant renal impairment ( \> 1\.5 times the upper limit of normal (ULN) of serum creatinine)
- •8\. Active hepatic disease
- •9\. Acute meniscal injury to the study joint within 2 years of study entry, arthroscopy in the study joint within 6 months of the study entry
- •10\. Weight in excess of 280 pounds (120 kg)
结局指标
主要结局
未指定
相似试验
尚未招募
1 期
A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosaretinitis pigmentosaITMCTR2100005438eye hospital, China Academy of Chinese Medical Sciences
招募中
1 期
Chinese medicine prevention and treatment program for novel coronavirus pneumonia (COVID-19): a perspective, double-blind, placebo, randomised controlled trialnovel coronavirus pneumonia (NCP)ITMCTR2000002964Zhejiang Chinese Medical University
进行中（未招募）
不适用
A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisMyasthenia gravisMedDRA version: 7.1Level: LLTClassification code 10028417EUCTR2004-000596-34-CZF.Hoffmann-La Roche Ltd.136
进行中（未招募）
1 期
A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)EUCTR2005-001688-74-GBGuy's & St Thomas' NHS Foundation Trust70
尚未招募
3 期
In this study Garcinol 20% would be compared with an inert substance in reducing the risk of metabolic syndrome in obese individuals.CTRI/2020/02/023571Sami Labs Limited