NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain

Study Overview
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Brief Summary
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Osteoarthritis is characterized by the breakdown of cartilage in joints. As cartilage deteriorates, the bones of the joint begin to run against one another, causing stiffness and pain, which often impairs movement. Osteoarthritis also can damage ligaments, menisci, and muscles. Bone or cartilage fragments may float in the joint space, causing irritation and pain. Bone spurs, or osteophytes, may also develop, causing additional pain and potentially damaging surrounding tissues. Around the world, an estimated 10%-15% of adults over 60 have some degree of osteoarthritis. It most commonly affects the joints in the knee, hands, feet, and spine, and is also relatively common in other joints such as the shoulder and hip joints. There are two types of osteoarthritis: primary and secondary. Primary osteoarthritis is a chronic degenerative disease that is related to, but not caused by, aging. As a person ages, the water content of their cartilage decreases, thus weakening it and making it less resilient and more susceptible to degradation. There are strong indications that genetic inheritance is a factor, as up to 60% of all OA cases are thought to result from genetic factors. The main symptoms are pain, loss of ability, and joint stiffness after exercise or use. These symptoms are often aggravated by activity or rigorous exercise and relieved during rest, though the disease may eventually progress to the point where the patient even feels pain when resting, and some people report pain so intense that it wakes them up when they are sleeping. Osteoarthritis, at present, cannot be cured, and will likely get worse over time, but the symptoms can be controlled. Treatments vary widely, from alternative medicine, to lifestyle changes such as exercise and diet, to physical aids such as canes or braces, to medications such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroids, and more. Osteoarthritis is the most common joint disease of human. Among the elderly knee osteoarthritis is leading cause of chronic disability in developed countries. Some people in India are unable to walk independently from bed and bath-room because of Osteoarthritis of the knee or hip joint. Osteoarthritis (OA) also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion. A variety of causes viz. hereditary, developmental, metabolic, and mechanical may initiate processes leading to loss of cartilage. When bone surfaces are not well protected by cartilage, bone may get exposed and damaged. As a result of decreased movement secondary to pain, atrophy of regional muscles, and ligaments may become more lax. The goal of treatment is to reduce or eliminate the signs and symptoms of Osteoarthritis. Mild to moderate disease is often treated with topical therapies. Sponsor has developed the NGA-01Gel containing the fixed dose combination of alcohol and water mixture, with active herbal ingredients, without preservatives and dyes. The Gel is easy to apply, and the cosmetic appearance is that of a white, milky gel, easily-spreadable that absorbs completely into the skin a few minutes after application and it is expected that the Gel will differentiate from marketed formulations by patient preference for the gel and gel.

Official Title
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A Double Blind, Randomized, Parallel Group Study to Evaluate Efficacy and Safety of NGA-01 Gel Against Placebo in the Treatment of Osteoarthritis With Joint Pain

Conditions
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Arthritis Osteoarthritis

Intervention / Treatment
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* Other: NGA-01 gel
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and extension, crepitus, swelling etc for more than 3 months prior to the study. Pain score of at least 4 cm on a 10-cm linear visual analogue scale. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment period. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study. Are willing to avoid participation in any other interventional clinical trial for the duration of this study. Exclusion Criteria: Are pregnant, breast-feeding, or planning to become pregnant during the study. Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis, Gouty Arthritis. Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and treatment. Severe Stomach infection. Severely traumatised and/or very severe or mucosal inflammation Peritonsillar abscess Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including Non Steroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen) Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization Any paracetamol intake within 6 hours before randomisation Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation Heavy smokers (>10 cigarettes/day) Have open sores or open lesions in the treatment area(s). Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque Arthritis. Have participated in any interventional clinical trial in the previous 30 days. Have a known sensitivity to any of the constituents of the test product Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years. Plan to seek alternative treatment of any kind for their Arthritis, in the eligible treatment areas or otherwise, during the trial period.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind, randomized, parallel group study against placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NGA-01 gel<br>A formulation with natural ingredients expected to be used for joint pain in Osteoarthritis | Other: NGA-01 gel<br>* NGA-01 is a gel formulation with mostly herbal active ingredients<br>|
| Placebo Comparator: Placebo gel<br>Placebo gel with no active ingredient | Other: Placebo<br>* A Placebo with no active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain visual analog scale (VAS) scores (0-10) from baseline | Pain was recorded as per physician's analysis as per SOP, 0 as lowest and 10 as highest | Day 0 - Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC scores | Western Ontario and McMaster Universities Arthritis Index is used to determine severity of arthritis | Day 0 - Day 60 | 
| Change in Numeric Pain Rating Scale (NPRS) score | Pain is measured as per regular NPRS scale | Day 0 - Day 60 | 
| Change in Range of motion (ROM) | physical assessment by the doctor | Day 0 - Day 60 | 
| Change in Physician's Global Assessment of Arthritis | The physicians analysed data is recorded | Day 0 - Day 60 | 
| Change in Patient's Global Assessment of Arthritis | The customer questionnaire based data is recorded. | Day 0 - Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, pain