A clinical study to assess the benefits of Concentrace Trace Mineral Drops-(CTMD®), a food supplement in subjects with OSTEOARTHRITIS (OA) of knee joint

Phase 4

Completed

• Registration Number: CTRI/2010/091/001105
• Lead Sponsor: Dr. Himanshu Bansal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary End Points Are  Pain Score Range Of Movement 6min-Free Walking Distance Reduction In Pain Medication Change In Quality Of Life (WOMAC SCORE)Timepoint:  Pain Score Range Of Movement 6min-Free Walking Distance Reduction In Pain Medication Change In Quality Of Life (WOMAC SCORE)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints 1. Change In Ultrasonography 2. Change In Synovial FluidTimepoint: 1. Change In Ultrasonography 2. Change In Synovial Fluid