- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117490
To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
A Double Blind, Double Dummy, Dose Response, Randomized, Placebo Controlled Study to Assess the Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maharashtra
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Mumbai, Maharashtra, India, 400067
- Ayush Nursing Home
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Mumbai, Maharashtra, India, 400 070
- Kurla Nursing Home
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Mumbai, Maharashtra, India, 400 074
- Sai Baba Hospital
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Mumbai, Maharashtra, India, 400064
- Diamond Hospital
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Mumbai, Maharashtra, India, 400067
- Dinanath Orthopaedic Nursing Home
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Mumbai, Maharashtra, India, 400068
- K. K. Medical Centre
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Mumbai, Maharashtra, India, 400092
- Healthcare Medical Center and diagnostics
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Navi Mumbai, Maharashtra, India, 400708
- Rainbow Multispeciality hospital and trauma center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. 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).
7. 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.
10. Female participants of childbearing age must be willing to use the accepted methods of contraception during the course of the study.
11. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Epiitalis low dose
Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Active Comparator: Epiitalis mid dose
Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Active Comparator: Epiitalis high dose
Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Two capsules twice daily 30 mins before meals (breakfast & dinner).
|
Placebo Comparator: Placebo
Two capsules twice daily 30 mins before meals (breakfast & dinner).
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Two capsules twice daily 30 mins before meals (breakfast & dinner).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of consumption of IP on knee joint pain as assessed by the change in the 100-point Visual Analogue Scale (VAS) from baseline and when compared with the placebo.
Time Frame: From baseline to 56 days
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Participant's assessment of pain will be done on a 100 mm Visual Analogue Scale (Pain), where 0 means no pain and 100 means unbearable pain.
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From baseline to 56 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life as assessed by a SF-36 questionnaire
Time Frame: From baseline to 56 days
|
The 36 Item Short Form Health Survey (SF36) Questionnaire is a set of generic, coherent, and easily administered quality of life measures.
These measures rely upon participant self reporting.
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From baseline to 56 days
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Effect of IP consumption and the placebo on Knee joint pain, Knee joint stiffness & Knee joint function as assessed by a specific questionnaire
Time Frame: From baseline to 56 days
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WOMAC is a widely used questionnaire for Osteoarthritis.
WOMAC Index is a tri dimensional self administered questionnaire to assess joint pain, stiffness & physical function.
WOMAC Pain comprises of 5 questions related to knee joint pain that score fro 0 to 4 (0 means no pain & 4 means extreme pain).
WOMAC Stiffness consists of 2 items (score 0-4, 0 means no stiffness and 4 means extreme stiffness).
WOMAC Physical function consists of 17 items with scores 0 to 4 with same scoring pattern.
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From baseline to 56 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IP/190401/EPIITALIS/OA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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