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

NCT ID: NCT02417506

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-02-28

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.

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

E-OA-07 (Lanconone)

500 mg two capsules to be taken stat at the site

Group Type: EXPERIMENTAL

E-OA-07 (Lanconone)

Intervention Type: OTHER

Ibuprofen

200 mg two capsule to be taken stat at the site

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Interventions

E-OA-07 (Lanconone)

Intervention Type: OTHER

Ibuprofen

Intervention Type: DRUG

Other Intervention Names

Investigational Product; Comparator

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enovate Biolife Pvt Ltd

INDUSTRY

Sponsor Role: collaborator

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shalini Srivastava, M.D.

Role: STUDY_CHAIR

Locations

Mukund Hospital

Mumbai, Maharashtra, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 27052991 (View on PubMed)

Other Identifiers

EB/ 140501 /LC/ OA

Identifier Type: -

Identifier Source: org_study_id