Status:
COMPLETED
To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
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 ingr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2020
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT04117490
Start Date
December 12 2019
End Date
October 21 2020
Last Update
February 1 2022
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Kurla Nursing Home
Mumbai, Maharashtra, India, 400 070
2
Sai Baba Hospital
Mumbai, Maharashtra, India, 400 074
3
Diamond Hospital
Mumbai, Maharashtra, India, 400064
4
Ayush Nursing Home
Mumbai, Maharashtra, India, 400067