Knee OsteoarthritisNCT04117490
To Assess Efficacy of Epiitalis on Knee Pain in Patients Suffering From Knee Osteoarthritis
A study testing Epiitalis in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
Trial 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 ingredient in the treatment of mild to moderate cases of knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Epiitalis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 8 sitesIndia
- Study dates
- 12 Dec 2019to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Kurla Nursing Home
Mumbai, Maharashtra, 400 070
Sai Baba Hospital
Mumbai, Maharashtra, 400 074
Diamond Hospital
Mumbai, Maharashtra, 400064
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Dinanath Orthopaedic Nursing Home
Mumbai, Maharashtra, 400067
K. K. Medical Centre
Mumbai, Maharashtra, 400068
Healthcare Medical Center and diagnostics
Mumbai, Maharashtra, 400092
Rainbow multispeciality hospital and trauma center
Navi Mumbai, Maharashtra, 400708
About this study
Official title: 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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Epiitalis, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiitalisOther
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
PlaceboOther
Two capsules twice daily 30 mins before meals (breakfast \& dinner).
| Study group | Role | What they receive |
|---|---|---|
| Epiitalis low dose | Active comparator | Two capsules twice daily 30 mins before meals (breakfast \& dinner). Receives: Other: Epiitalis |
| Epiitalis mid dose | Active comparator | Two capsules twice daily 30 mins before meals (breakfast \& dinner). Receives: Other: Epiitalis |
| Epiitalis high dose | Active comparator | Two capsules twice daily 30 mins before meals (breakfast \& dinner). Receives: Other: Epiitalis |
| Placebo | Placebo comparator | Two capsules twice daily 30 mins before meals (breakfast \& dinner). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: From baseline to 56 days
Secondary outcomes (2)
Quality of life as assessed by a SF-36 questionnaire
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.
Measured: From baseline to 56 days
Effect of IP consumption and the placebo on Knee joint pain, Knee joint stiffness & Knee joint function as assessed by a specific questionnaire
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.
Measured: From baseline to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start12 Dec 2019
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117490
- Sponsor's protocol ID
- IP/190401/EPIITALIS/OA
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35732989
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04117490
- Acronym / sponsor ID
- IP/190401/EPIITALIS/OA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epiitalis low dose | Active comparator | Other: EpiitalisTwo capsules twice daily 30 mins before meals (breakfast \& dinner). |
| Epiitalis mid dose | Active comparator | Other: EpiitalisTwo capsules twice daily 30 mins before meals (breakfast \& dinner). |
| Epiitalis high dose | Active comparator | Other: EpiitalisTwo capsules twice daily 30 mins before meals (breakfast \& dinner). |
| Placebo | Placebo comparator | Other: PlaceboTwo capsules twice daily 30 mins before meals (breakfast \& dinner). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiitalisTwo capsules twice daily 30 mins before meals (breakfast \& dinner). | Other | Epiitalis high dose, Epiitalis low dose, Epiitalis mid dose |
| PlaceboTwo capsules twice daily 30 mins before meals (breakfast \& dinner). | Other | Placebo |
Primary outcome
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
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.
2 secondary outcomes
Quality of life as assessed by a SF-36 questionnaire
Time frame: From baseline to 56 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 35732989Mitchell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epiitalis in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.