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

NCT03262805 | Completed

• 1 other identifier: EB/170401/LC/OA
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Osteoarthritis

Keywords

Knee OA; Joint Pain; Dietary supplement; WOMAC; Lequesne index; hs-CRP

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (8)

• WOMAC stiffness score

  28 days

• WOMAC physical performance score.

  28 days

• Lequesne Functional Index

  28 days

• Serum hs-CRP levels.

  28 days

• BMI

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Active

ACTIVE COMPARATOR

Lanconone(R)

Dietary Supplement: Lanconone

Interventions

Lanconone DIETARY_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.

Active

Placebo OTHER

Microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (3)

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Kewalramani's Clinic

Mumbai, Maharashtra, 400068, India

Location

KK Medical Centre

Mumbai, Maharashtra, 400068, India

Location

Related Publications (1)

• 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.

  PMID: 27052991 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shalini Srivastava, MD

  Enovate Biolife Pvt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel group study.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: August 28, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

IN (3)