Study to Assess the Effect of E-OA-07 on Acute Pain Response in Subjects Suffering From Knee OA (Osteolanc)

May 6, 2015 updated by: Vedic Lifesciences Pvt. Ltd.

A Double Blind Randomized Comparator Controlled Study to Assess the Effect of E-OA-07 (Lanconone) on Acute Pain Response in Subjects Suffering From Osteoarthritis of the Knee

The repetitive motions associated with active life and many sports can increase the wear and tear to the joints that leads to decrease in flexibility and joint pain finally heading its way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that supports and cushions the joints of hands and knees, causing bones to rub against each other. Injuries stemming from repetitive motions can also cause and worsen the joint pain.

Joint pain is discomfort that arises from any joint . Irrespective of the underlying mechanisms, joint pain usually originates in activation of nociceptors, or free nerve endings. Complex neuronal activation occurs, which involves not only local sensitization of joint nociceptors but also modifications in central pain pathways.

Even though, the numerous pharmacological interventions are available for joint pain, there is much debate amongst clinicians about the best approach to the treatment of joint pain. NSAIDs which is frequently used for treatment in such cases, carries concerns related to gastro-intestinal system, cardiovascular system as well as central nervous system .

Hence there is a need of a safer alternative treatment option for relieving acute joint pain which is comparable to the modern medicines, without posing concerns to the subject's general well being.

Herbs are known to be used since ages in traditional literature and do not pose any potential health concern. Inspite of such positive attributes herbs are not employed in treatment of acute pains as there is lack of evidence proving the same.

In order to address the need of the hour Enovate Biolife has invented a novel poly herbal formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with osteoarthritis has been proven efficacious . It has a good history of marketing and is sold in the United States, with no reported adverse event related to the product. However there is no concrete evidence proving the product's acute pain relieving dynamics, hence the current study has been employed to comprehend the effect of lanconone in joint acute pain.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • 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

    • Maharashtra
      • Mumbai, Maharashtra, India, 400059
        • Mukund Hospital

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

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory adults of either sex aged 40 to 60 years.
  • Subjects with moderate OA of the knee, which can be clinically, categorized as ARA functional Class II and III with radiological confirmation of Kellgren Lawrence Grade II and III. (incase of bilateral OA, the knee with the more severe symptoms will be defined as index joint)
  • Subjects with OA in a flare state at the baseline defined by one of following category of flare:

In subjects who have been receiving non steroidal anti-inflammatory drugs (NSAIDs) or analgesic therapy for their OA, flare will be defined as having at least two of the following three criteria while comparing screening to baseline:

  1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥ 40 mm;
  2. Increase of ≥ 1 grade in the patients global assessment of arthritis;
  3. Increase of ≥ 1 grade in the physician's global assessment of arthritis;

In subjects who are not receiving NSAID or analgesic therapy , an OA flare state will be defined as having at least two of the following three criteria

  1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥ 40 mm
  2. Patient's global assessment of arthritis of ''poor''; very poor
  3. Physician's global assessment of arthritis of ''poor''; very poor

Exclusion Criteria:

  • Subjects with any form of arthritis other than osteoarthritis.
  • Administration of intra-articular or oral steroids in the past 3 month or intra articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs
  • History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections
  • Subjects with localized trauma to the lower limb
  • Had received oral, intramuscular, or intra-articular corticosteroids within 8 weeks, or intra-articular hyaluronic acid in the index joint within 6 months of study drug administration;
  • Subjects on nutritional supplement or herbal product since last one month
  • 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-OA-07 (Lanconone)
500 mg two capsules to be taken stat at the site
Other Names:
  • Investigational Product
Active Comparator: Ibuprofen
200 mg two capsule to be taken stat at the site
Other Names:
  • Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain score as measured by Visual Analogue Scale
Time Frame: Day 0
Day 0

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Chair: Shalini Srivastava, M.D.

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.

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

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

May 1, 2015

More Information

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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