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

Sponsor

Vedic Lifesciences Pvt. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02417506

Collaborator

Enovate Biolife Pvt Ltd (Industry)

Enrollment

Location

Arms

Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of Knee	Other: E-OA-07 (Lanconone) Drug: Ibuprofen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: E-OA-07 (Lanconone)

500 mg two capsules to be taken stat at the site

Other: E-OA-07 (Lanconone)

Other Names:

Investigational Product

Active Comparator: Ibuprofen

200 mg two capsule to be taken stat at the site

Drug: Ibuprofen

Other Names:

Comparator

Outcome Measures

Primary Outcome Measures

Pain score as measured by Visual Analogue Scale [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

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