CTRI/2021/03/031916已完成2 期
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.
utrin GmbH0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •- 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 (ââ?°Â¥ 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.
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