CTRI/2019/06/019881CompletedPhase 2/3
A randomized controlled single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteoarthritis of knee joints.
National innovation foundation1 site in 1 country300 target enrollmentStarted: January 7, 2019Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- To compare the efficacy and safety of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu) and Allopathic drug(Acetominophen) in subject with Osteoarthritis of knee joints
Study Overview
Brief Summary
This randomized multi arm controlled,single blind clinical trial will be done for safety and efficacy of two grassroots leads in the management of osteoarthritis of knee joints. Two grassroots leads in two different formulation and in two different doses will be compared against standard Ayurvedic drugs and standard allopathic drug. Each group will be given 12 week of medication and trial will be completed in three years
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with Primary Osteoarthritis – knee joints (single or both knees) 2.Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening 3.Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 5-point Likert Pain Subscale) assessed at screening 4.Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used) 5.No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure
- •No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
Exclusion Criteria
- •Patient with history of hypersensitivity to any drugs.
- •Presence of tense effusions
- •Patients with Pott’s spine/infections/other systemic diseases
- •Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.
- •Patients with Diabetes/Hypertension
- •Bed ridden patients
- •Chondromalacia
- •Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
- •Major injury to the index knee within the 12 months prior to screening
- •Severe hip osteoarthritis ipsilateral to the index knee.
- •Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
- •Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
- •Patients with metallic implants.
- •History of bony or soft tissue injury to knee joint.
- •No human albumin treatment in the 3 months before randomization or throughout the duration of the study.
- •16.Pregnant and lactating women.
Outcomes
Primary Outcomes
To compare the efficacy and safety of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu) and Allopathic drug(Acetominophen) in subject with Osteoarthritis of knee joints
Time Frame: 12 weeks
Secondary Outcomes
- Mean changes from baseline in Patient’s Global Assessment of response to therapy(12 weeks)
- Mean changes from baseline in Physician’s Global Assessment of response to therapy.(12 weeks)
Investigators
Study Sites (1)
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