To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
Status
Conditions
Treatments
Details and patient eligibility
About
Epiitalis is an ingredient of a currently marketed product named as Osteo-Restore, indicated for joint health.The present study is primarily planned to establish the role of Epiitalis as a single ingredient in the treatment of mild to moderate cases of knee Osteoarthritis.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male & female aged ≥ 40 to ≤ 65 years suffering from primary idiopathic osteoarthritis of the knee diagnosed at least 3 months prior to screening.
2 BMI ≥ 18 and ≤ 29.9 kg/m2. 3 Fasting blood sugar ≤ 126 mg/dl 4 LFT: Serum Glutamic oxaloacetic transaminase (SGOT) & <2X Upper Limit of Normal (UNL) and Serum Glutamic-Pyruvic transaminase (SGPT) & <2X UNL.
5 Serum Creatinine & <1.5X UNL. 6 Index knee joint pain rated ≥ 60 on a 100-point Pain-Visual Analogue Scale (VAS).
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Osteoarthritis grade II/ III (Kellgren-Lawrence classification) as confirmed by: Grade II - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph Grade III - Multiple osteophytes, definite JSN, sclerosis, and possible bony deformity 8. Systolic blood pressure & <140 mmHg and diastolic blood pressure & < 90 mmHg 9. In the case of hypothyroidism, only euthyroid patients will be allowed to be screened further. Blood reports of last 3 months will be valid at the time of screening.
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Female participants of childbearing age must be willing to use the accepted methods of contraception during the course of the study.
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Participants should be willing to be involved in some
Exclusion criteria
- History of osteoarthritis for more than 3 years.
- History of osteoporosis and/or frequent fractures.
- History of major trauma to the index joint.
- History of arthroscopic surgery or intervention on the index joint or awaiting a replacement of knee or hip joint.
- History of restless leg syndrome.
- Participants who have received intra-articular steroids or hyaluronic acid within the last three months.
- Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health.
- Not willing to abstain from application of local analgesics, herbal oil 48 hours prior to study visit.
- Use of any immunosuppressive drugs in the last 12 months (including steroids).
- Participants with deformity of the knee joint.
- Participants categorized as ACR Functional Class I osteoarthritis
- Participants who are significantly incapacitated or disabled and would be categorized as ACR Functional Class IV osteoarthritis (largely or wholly incapacitated), or unable to walk without assistive devices.
- Participants with other known rheumatic or inflammatory diseases such as rheumatoid arthritis, osteomyelitis, and bone metastasis.
- Current smokers or chronic alcoholics.
- History of bleeding disorders.
- Participants suffering from deep vein thrombosis.
- Participants suffering from diabetic neuropathy.
- History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
- Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.
- Participants having a history of any malignancy.
- Inability to comply with the protocol requirements.
- Participation in any other clinical trial within 3 months of registering in this trial.
- . Women of child-bearing potential with a positive pregnancy test or who are lactating.
- Any other condition which in the opinion of the Investigator may jeopardize the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
237 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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