Knee OsteoarthritisLEAPNCT03262805
To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
A study testing Lanconone in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
Trial summary
The current study is designed to assess the pain relieving effect of 4-weeks ingestion of this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per day) in mild to moderate OA subjects. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lanconone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesIndia
- Study dates
- 28 Aug 2017to 30 Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater than 3 months as presented by pain in knee.
- Body mass index (BMI) must be 25 to 29.9 kg/m2.
- WOMAC pain score for index joint: 10 to 16.
- Physically active subjects as indicated by day to day involvement in the mentioned physical activity namely:
- Daily walk of 500 to 1000 meters.
- Routine activities such as descending/ ascending stairs, standing up from a chair; bending to floor; travelling by public transport, domestic cleaning etc.
- Climbing 1 or more fleets of stairs.
- Osteoarthritis grade I/ II (Kellgren-Lawrence classification) as confirmed by radiographic evidence.
Who cannot join
- Subjects with a history of any joint replacement surgery.
- Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health/ local analgesics or other traditional pain relieving therapies such as message or acupuncture etc. during the study duration will be excluded.
- Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or diastolic ≥ 100 mm Hg) at screening.
- Subjects with history of thyroid hormone derangement will have to provide a recent (within 3 months) thyroid profile report indicative of euthyroid status.
- Use of any immunosuppressive drugs in the last 12 months.
- Use of any corticosteroids drugs in the last 3 months.
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- Subject unwilling to refrain from analgesic measures at least 48 hours before each site visit.
- FBS >140 mg/dl.
- History of restless leg syndrome.
- Glucocorticoid injection or hyaluronic acid injection in affected joint within 3 months prior to enrolment.
- Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy.
- Smokers and tobacco users.
- Alcohol consumption of more than 200 ml/ week
- History of surgery in lower limb.
- Subjects suffering from diabetic neuropathy.
- Subjects suffering from deep vein thrombosis.
- Pregnant / lactating women and women who are planning to get pregnant.
- Recent (< 3 months) participation in a clinical study.
- History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
- Subjects with localized trauma to the lower limb.
- A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms.
- Subjects planning to travel in the next 35 days or engage in any non-routine activity that is likely to strain the knees.
- Subject a history of malignancy, active gastrointestinal disease, chronic or acute renal/hepatic disorders, or significant coagulation disorders.
- Subjects on vitamins, nutritional supplement or herbal product since last 2 weeks.
- Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Kewalramani's Clinic
Mumbai, Maharashtra, 400068
KK Medical Centre
Mumbai, Maharashtra, 400068
About this study
The current study is designed to assess the pain relieving effect of 4-weeks ingestion of this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per day) in mild to moderate OA subjects. Also, the current study intends to assess the safety and efficacy of long term administration of Lanconone in larger sample size as compared to the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and function by means of self-reported WOMAC \& Lequesne questionnaire.The effect of IP on clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.
Read the detailed description
This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall joint health in the population of ≥ 40 years of age during the daily life activities by the reduction of the joint pain and discomfort. Assessment of pain is the primary objective which will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The early onset of action (3 days after commencement of the IP administration) for pain relief which was not captured in the past studies, will be captured in the current study by the telephonic assessment of the study subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the secondary objectives. Also, the rescue medication consumption has been limited to lower per day consumption compared to earlier studies to avoid the placebo effect influence on the study results. The efficacy of the IP in sustaining the pain relieving effect will be analyzed on day 35, i.e. one week after the end of the treatment.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lanconone, Placebo
- Keywords
- Knee OA, Joint Pain, Dietary supplement, WOMAC, Lequesne index, hs-CRP
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LancononeDietary supplement
. Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.
PlaceboOther
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Active | Active comparator | Lanconone(R) Receives: Dietary Supplement: Lanconone |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC pain score.
- Change in terms of percentage reduction of joint pain from baseline to Day 28 during daily life activities assessed by WOMAC pain score.
Measured: 28 days
Secondary outcomes (8)
WOMAC stiffness score
Change in terms of percentage reduction of joint pain from baseline to Day 28 joint stiffness as assessed by WOMAC stiffness score.
Measured: 28 days
WOMAC physical performance score.
Change in terms of percentage reduction of joint pain from baseline to Day 28 in physical performance during daily life activities as assessed by WOMAC physical performance score.
Measured: 28 days
Lequesne Functional Index
% reduction in joint degradation process as from baseline to Day 28 as assessed by Lequesne Functional Index
Measured: 28 days
Serum hs-CRP levels.
% reduction in joint pain marker from baseline to Day 28 as assessed by serum hs-CRP levels.
Measured: 28 days
BMI
% change in joint degradation related risk factor from baseline to Day 28 as assessed by BMI.
Measured: 28 days
% responders
Comparison of uniformity of positive pain relieving individual response as assessed by % responders with ≥ 17% reduction in WOMAC pain score at Day 28.
Measured: 28 days
Rescue medication consumption
Comparison of alternate analgesic therapy requirement as assessed by number of rescue medication consumption during the study.
Measured: 28 days
Sustained effect
- To assess the sustained drug free period as assessed by WOMAC pain score joint pain at Day 35 as compared to Day 28.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start28 Aug 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shalini Srivastava, MD, Study director, Enovate Biolife Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262805
- Sponsor's protocol ID
- EB/170401/LC/OA
- Acronym
- LEAP
- Status last verified
- Apr 2018
- First submitted
- 23 Aug 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Girandola RN, Srivastava S, Loullis CC. A clinical trial comparing Lanconone(R) with ibuprofen for rapid relief in acute joint pain. Trials. 2016 Apr 6;17:189. doi: 10.1186/s13063-016-1268-6.
PubMed 27052991
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
- ClinicalTrials.gov ID
- NCT03262805
- Acronym / sponsor ID
- LEAP / EB/170401/LC/OA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee OA, Joint Pain, Dietary supplement, WOMAC, Lequesne index, hs-CRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 25 Aug 2017 (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.
The current study is designed to assess the pain relieving effect of 4-weeks ingestion of this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per day) in mild to moderate OA subjects. Also, the current study intends to assess the safety and efficacy of long term administration of Lanconone in larger sample size as compared to the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and function by means of self-reported WOMAC \& Lequesne questionnaire.The effect of IP on clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.
Detailed description
This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall joint health in the population of ≥ 40 years of age during the daily life activities by the reduction of the joint pain and discomfort. Assessment of pain is the primary objective which will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The early onset of action (3 days after commencement of the IP administration) for pain relief which was not captured in the past studies, will be captured in the current study by the telephonic assessment of the study subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the secondary objectives. Also, the rescue medication consumption has been limited to lower per day consumption compared to earlier studies to avoid the placebo effect influence on the study results. The efficacy of the IP in sustaining the pain relieving effect will be analyzed on day 35, i.e. one week after the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Active | Active comparator | Dietary Supplement: LancononeLanconone(R) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater than 3 months as presented by pain in knee.
- Body mass index (BMI) must be 25 to 29.9 kg/m2.
- WOMAC pain score for index joint: 10 to 16.
- Physically active subjects as indicated by day to day involvement in the mentioned physical activity namely:
- Daily walk of 500 to 1000 meters.
Key exclusion criteria (25 listed)
- Subjects with a history of any joint replacement surgery.
- Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health/ local analgesics or other traditional pain relieving therapies such as message or acupuncture etc. during the study duration will be excluded.
- Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or diastolic ≥ 100 mm Hg) at screening.
- Subjects with history of thyroid hormone derangement will have to provide a recent (within 3 months) thyroid profile report indicative of euthyroid status.
- Use of any immunosuppressive drugs in the last 12 months.
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 |
|---|---|---|
| Lanconone. Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers. | Dietary supplement | Active |
| PlaceboMicrocrystalline cellulose | Other | Placebo |
Primary outcome
WOMAC pain score.
Time frame: 28 days
• Change in terms of percentage reduction of joint pain from baseline to Day 28 during daily life activities assessed by WOMAC pain score.
8 secondary outcomes
WOMAC stiffness score
Time frame: 28 days
WOMAC physical performance score.
Time frame: 28 days
Lequesne Functional Index
Time frame: 28 days
Serum hs-CRP levels.
Time frame: 28 days
BMI
Time frame: 28 days
% responders
Time frame: 28 days
Rescue medication consumption
Time frame: 28 days
Sustained effect
Time frame: 35 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 30 Apr 2018.
- Background: PubMed 27052991Girandola RN, Srivastava S, Loullis CC. A clinical trial comparing Lanconone(R) with ibuprofen for rapid relief in acute joint pain. Trials. 2016 Apr 6;17:189. doi: 10.1186/s13063-016-1268-6.
- Individual participant dataSharing planned: Undecided
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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.
Shalini Srivastava, MD study director
Enovate Biolife Pvt Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lanconone in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 3 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 8 inclusion and 25 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
WOMAC pain score. (time frame: 28 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 NCT03262805, 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 30 Apr 2018.