Clinical trial NCT03262805: To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
Official title: To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee OA
Joint Pain
Dietary supplement
WOMAC
Lequesne index
hs-CRP
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 73
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group study.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: WOMAC pain score.
timeFrame: 28 days
Secondary outcomes:
measure: WOMAC stiffness score
timeFrame: 28 days
measure: WOMAC physical performance score.
timeFrame: 28 days
measure: Lequesne Functional Index
timeFrame: 28 days
measure: Serum hs-CRP levels.
timeFrame: 28 days
measure: BMI
timeFrame: 28 days
measure: % responders
timeFrame: 28 days
measure: Rescue medication consumption
timeFrame: 28 days
measure: Sustained effect
timeFrame: 35 days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Ayush Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: Kewalramani's Clinic
state: Maharashtra
city: Mumbai
country: India
facility: KK Medical Centre
state: Maharashtra
Study officials:
affiliation: Enovate Biolife Pvt Ltd
name: Shalini Srivastava, MD
role: STUDY_DIRECTOR
References:
citation: 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.