To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study (LEAP)

April 27, 2018 updated by: Vedic Lifesciences Pvt. Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400067
        • Ayush Nursing Home
      • Mumbai, Maharashtra, India, 400068
        • Kewalramani's Clinic
      • Mumbai, Maharashtra, India, 400068
        • KK Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Microcrystalline cellulose
Active Comparator: Active
Lanconone(R)
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WOMAC stiffness score
Time Frame: 28 days
Change in terms of percentage reduction of joint pain from baseline to Day 28 joint stiffness as assessed by WOMAC stiffness score.
28 days
WOMAC physical performance score.
Time Frame: 28 days
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.
28 days
Lequesne Functional Index
Time Frame: 28 days
% reduction in joint degradation process as from baseline to Day 28 as assessed by Lequesne Functional Index
28 days
Serum hs-CRP levels.
Time Frame: 28 days
% reduction in joint pain marker from baseline to Day 28 as assessed by serum hs-CRP levels.
28 days
BMI
Time Frame: 28 days
% change in joint degradation related risk factor from baseline to Day 28 as assessed by BMI.
28 days
% responders
Time Frame: 28 days
Comparison of uniformity of positive pain relieving individual response as assessed by % responders with ≥ 17% reduction in WOMAC pain score at Day 28.
28 days
Rescue medication consumption
Time Frame: 28 days
Comparison of alternate analgesic therapy requirement as assessed by number of rescue medication consumption during the study.
28 days
Sustained effect
Time Frame: 35 days
• To assess the sustained drug free period as assessed by WOMAC pain score joint pain at Day 35 as compared to Day 28.
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shalini Srivastava, MD, Enovate Biolife Pvt Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EB/170401/LC/OA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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