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临床试验/CTRI/2010/091/001105
CTRI/2010/091/001105已完成4 期

?A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE CENTRIC AND PROSPECTIVE STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF CONCENTRACE TRACE MINERAL DROPS-(CTMD®), A FOOD SUPPLEMENT IN SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE JOINT?.

Dr. Himanshu Bansal0 个研究点目标入组 100 人开始时间: 待定最近更新:
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试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

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.Subjects of both sexes between 50-75 years of age
  • •2.Subjects who are willing to give informed consent
  • •3.Subjects who are willing to comply with the study procedure.
  • •4.Symptomatic knee- The pain or discomfort should have been experienced in the affected joint on most days for the previous 3 months
  • •5.History of less than 30 min of morning stiffness, Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index score ≤ 75 in the target knee and using NSAIDs/ analgesics (rescue medicine) at least once a week
  • •6.Physical examination revealing crepitus on active motion /bony tenderness /no palpable warmth of synovium
  • •7.Radiological defined, and classified as mild to moderate OA of knee joint ?
  • •Mild to moderate osteoarthritis was determined by radiological examination ? Kellgren Lawrence classification for knee osteoarthritis grade 0, I, II or Grade III.
  • •8. Laboratory findings- ESR <40mm/hr, rheumatoid factor <1:40 and synovial fluid examination showing signs of osteoarthritis

排除标准

  • •1.Severe osteoarthritis /overt joint deformity
  • •2.Existence of other forms of arthritis- rheumatoid arthritis, gout, pseudo gout, Paget's disease
  • •3.Patients with acute flare
  • •4.Patients with joint pain following trauma (secondary OA)
  • •5.Patients who may require surgical intervention
  • •6. Patients who have undergone joint replacement surgeries arthroscopy of either knee within the past year
  • •7.Intra-articular injections/therapies -if they received intramuscular/systemic corticosteroid injection within 4 weeks; intra-articular corticosteroid injection within 6 months; or inter-articular hyaluronic acid injection within 12 months prior to enrollment.
  • •8.Patients with history of gastritis, peptic ulcer, bleeding ulcers
  • •9.Patients with clinically significant cardiovascular, hepatic, renal, haematological, pancreatic metabolic, neurological or seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
  • •10.Clinically significant laboratory abnormalities, which in the judgement of the physician, would interfere with the subjects participation in the study or evaluation of the subject?s response to therapy

研究者

发起方
Dr. Himanshu Bansal

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