Effect of LANCONONE in Weight-bearing Joint Pain

To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain

The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Dietary supplement: Lanconone®; Dietary supplement: Methyl crystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400067
      • Ayush Nursing Home
    • Mumbai, Maharashtra, India, 400067
      • Dinanath Nursing Home
    • Mumbai, Maharashtra, India, 400068
      • K.K Medical Centre
    • Mumbai, Maharashtra, India, 400076
      • Siddhant Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. BMI ≥ 25 and ≤ 29.9 kg/m2.
2. With unilateral or bilateral OA of the knee for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.
3. Post-menopausal females (LMP at least 12 months prior to the screening).

Exclusion Criteria:

1. History of osteoarthritis for more than 3 years.
2. Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg
3. FBS>140 mg/dl.
4. Smokers or chronic alcoholics.
5. Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lanconone®; Lanconone®: 2 Capsules once a day after breakfast	Dietary supplement: Lanconone®; 2 capsules
Placebo Comparator: Methyl Crystalline Cellulose; 2 Capsules once a day after breakfast	Dietary supplement: Methyl crystalline cellulose; 2 Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score	Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain.	56 days

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): January 9, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 1, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia; Osteoarthritis, Knee
• Other Study ID Numbers: EB/180601/LANCONONE/PAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No