Health Condition 1: null- ADULT PATIENTS WITH GRADE I AND GARDE II KELLGRANE AND LAWRENCE RADIOLOGICALLY DEFINED OSTEOARTHRITIS
Conditions
Interventions
Intervention1: CAPSULE ARTHRELLA: ONE CAPSULE TWICE A ADY
Control Intervention1: PLACEBO: ONE CAPSULE TWICE A DAY ORALLY FOR 12 WEEKS
Sponsors
Charak Pharma Pvt Ltd CPPL Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.To compare efficacy of Capsule Arthrella with placebo in patients with Osteoarthritis 2.To assess safety and tolerability of Capsule Arthrella compared with placebo in patients with Osteoarthritis Timepoint: 1.Number of patients showing improvement in laboratory investigations after 12 weeks of treatment 2.Investigatorâ??s global assessment 3.Patientsâ?? global assessment 4.Patientsâ?? reporting and investigatorâ??s assessment of adverse reactions(AR) | — |
Countries
India
Contacts
Public ContactDr Minal Vaidya
YMT AYURVEDIC COLLEGE KHARGHAR, NAVIMUMBAI
Outcome results
None listed