TO STUDY EFFICACY AND SAFETY OF CAPSULE ARTHRELLA COMPARED WITH PLACEBO IN OSTEOARTHRITIS
- Conditions
- Health Condition 1: null- ADULT PATIENTS WITH GRADE I AND GARDE II KELLGRANE AND LAWRENCE RADIOLOGICALLY DEFINED OSTEOARTHRITIS
- Registration Number
- CTRI/2015/03/005643
- Lead Sponsor
- Charak Pharma Pvt Ltd CPPL Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the efficacy of Capsule Arthrella in OsteoarthritisTimepoint: Change in WOMAC (Western Ontario and McMaster Universities) Score at every 4 weeks from baseline and last treatment visit.
- Secondary Outcome Measures
Name Time Method 1.To compare efficacy of Capsule Arthrella with placebo in patients with Osteoarthritis <br/ ><br>2.To assess safety and tolerability of Capsule Arthrella compared with placebo in patients with Osteoarthritis <br/ ><br>Timepoint: 1.Number of patients showing improvement in laboratory investigations after 12 weeks of treatment <br/ ><br> <br/ ><br> <br/ ><br>2.Investigatorâ??s global assessment <br/ ><br>3.Patientsâ?? global assessment <br/ ><br>4.Patientsâ?? reporting and investigatorâ??s assessment of adverse reactions(AR) <br/ ><br>