CTRI/2015/03/005643招募中2 期
A DOUBLE BLIND PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAPSULE ARTHRELLA IN OSTEOARTHRITIS - ARTH
Charak Pharma Pvt Ltd CPPL Mumbai0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- •The participant may enter the trial if ALL of the following apply:
- •Participant is willing and able to give informed consent for participation in the trial
- •Patients older than 40 years of age
- •Radiologically defined, symptomatic OA of knee joint or lumbar spine spondylosis
- •Disease stage (grade1or 2) based on the Kellgren and Lawrence radiographic system
- •The pain or discomfort should have been experienced in the affected joint on most days for the
- •previous 3 months
- •Participant has clinically acceptable laboratory results
- •In the investigatorâ??s opinion, is able and willing to comply with all trial requirements
- •Exclusion Criteria
- •The participant may not enter the trial if ANY of the following apply:
- •Patients with acute flare, overt joint deformity, joint pain following trauma
- •Patients who require surgical intervention
- •Patients who have undergone joint replacement surgeries
- •History of intraarticular injections/therapies within the previous month
- •Patients on any other concomitant medication (especially like corticosteroids)
- •Patients with clinically significant cardiovascular, hepatic, renal, haematological, pancreatic metabolic, neurological or clinically significant laboratory abnormalities, which in the judgement of the physician, would interfere with the subjects participation in the study or evaluation of the subjectâ??s response to therapy
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks
排除标准
- •Exclusion Criteria
- •The participant may not enter the trial if ANY of the following apply:
- •Patients with acute flare, overt joint deformity, joint pain following trauma
- •Patients who require surgical intervention
- •Patients who have undergone joint replacement surgeries
- •History of intraarticular injections/therapies within the previous month
- •Patients on any other concomitant medication (especially like corticosteroids)
- •Patients with clinically significant cardiovascular, hepatic, renal, haematological, pancreatic metabolic, neurological or clinically significant laboratory abnormalities, which in the judgement of the physician, would interfere with the subjects participation in the study or evaluation of the subjectâ??s response to therapy
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks
研究者
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