To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
NCT ID: NCT04117490
Last Updated: 2022-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
237 participants
INTERVENTIONAL
2019-12-12
2020-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Epiitalis low dose
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Epiitalis
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Epiitalis mid dose
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Epiitalis
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Epiitalis high dose
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Epiitalis
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Placebo
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Placebo
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Interventions
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Epiitalis
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Placebo
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
Eligibility Criteria
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Inclusion Criteria
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
2. History of osteoporosis and/or frequent fractures.
3. History of major trauma to the index joint.
4. History of arthroscopic surgery or intervention on the index joint or awaiting a replacement of knee or hip joint.
5. History of restless leg syndrome.
6. Participants who have received intra-articular steroids or hyaluronic acid within the last three months.
7. 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.
8. Not willing to abstain from application of local analgesics, herbal oil 48 hours prior to study visit.
9. Use of any immunosuppressive drugs in the last 12 months (including steroids).
10. Participants with deformity of the knee joint.
11. Participants categorized as ACR Functional Class I osteoarthritis
12. 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.
13. Participants with other known rheumatic or inflammatory diseases such as rheumatoid arthritis, osteomyelitis, and bone metastasis.
14. Current smokers or chronic alcoholics.
15. History of bleeding disorders.
16. Participants suffering from deep vein thrombosis.
17. Participants suffering from diabetic neuropathy.
18. History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
19. Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.
20. Participants having a history of any malignancy.
21. Inability to comply with the protocol requirements.
22. Participation in any other clinical trial within 3 months of registering in this trial.
23. . Women of child-bearing potential with a positive pregnancy test or who are lactating.
24. Any other condition which in the opinion of the Investigator may jeopardize the study.
40 Years
65 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Kurla Nursing Home
Mumbai, Maharashtra, India
Sai Baba Hospital
Mumbai, Maharashtra, India
Diamond Hospital
Mumbai, Maharashtra, India
Ayush Nursing Home
Mumbai, Maharashtra, India
Dinanath Orthopaedic Nursing Home
Mumbai, Maharashtra, India
K. K. Medical Centre
Mumbai, Maharashtra, India
Healthcare Medical Center and diagnostics
Mumbai, Maharashtra, India
Rainbow multispeciality hospital and trauma center
Navi Mumbai, Maharashtra, India
Countries
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References
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Mitchell PG, Bright CA, Bright DR, Srivastava SN, Raote SS, Kumar S. The Biota orientalis, oil extract Epiitalis(R), is efficacious at reducing the symptoms of knee osteoarthritis: a pilot, multi-site, dose-ranging, randomized, blinded, placebo-controlled trial. Inflammopharmacology. 2022 Aug;30(4):1323-1334. doi: 10.1007/s10787-022-01013-y. Epub 2022 Jun 22.
Other Identifiers
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IP/190401/EPIITALIS/OA
Identifier Type: -
Identifier Source: org_study_id
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