Back to results

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

Primary Purpose

Osteoarthritis of Knee

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

E-OA-07 (Lanconone)

Ibuprofen

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee focused on measuring Acute pain, Herbal, VAS, Stop watch

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Mukund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E-OA-07 (Lanconone)

Ibuprofen

Arm Description

500 mg two capsules to be taken stat at the site

200 mg two capsule to be taken stat at the site

Outcomes

Primary Outcome Measures

Pain score as measured by Visual Analogue Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02417506

First Posted

January 21, 2015

Last Updated

May 6, 2015

Sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborators

Enovate Biolife Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02417506

Brief Title

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

Acronym

Osteolanc

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 Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborators

Enovate Biolife Pvt Ltd

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of Knee

Keywords

Acute pain, Herbal, VAS, Stop watch

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E-OA-07 (Lanconone)

Arm Type

Experimental

Arm Description

500 mg two capsules to be taken stat at the site

Arm Title

Ibuprofen

Arm Type

Active Comparator

Arm Description

200 mg two capsule to be taken stat at the site

Intervention Type

Other

Intervention Name(s)

E-OA-07 (Lanconone)

Other Intervention Name(s)

Investigational Product

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

Comparator

Primary Outcome Measure Information:

Title

Pain score as measured by Visual Analogue Scale

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shalini Srivastava, M.D.

Official's Role

Study Chair

Facility Information:

Facility Name

Mukund Hospital

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400059

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

27052991

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs