CTRI/2021/12/039006已完成未知
A randomized, open label study to evaluate the efficacy and tolerability of CL16019 in accelerating bone fracture healing in subjects with distal radius fracture - NI
CLS Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •Male and female subjects aged between 30 and 50 years with a Body Mass Index-BMI of approximately 22 to 29 kg per meter square.
- •Subjects who are having distal radial arm fractures falling in the category Type 1, 2A, 2B as per Lidstrom classification.
- •Subjects with unilateral or bilateral distal arm fracture deemed to be appropriate for non-operative treatment.
- •Subjects who are willing to receive closed reduction or immobilisation for fracture as per the advice of study physician.
- •Subjects who do not have any other major injury except a distal radius fracture.
- •Willing to refrain from use of medications other than the prescribed medicine by study physician during the entire trial.
- •Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •Agree to participate in the study through a written informed consent.
排除标准
- •Subjects with more than one distal radius fracture.
- •History of a major orthopaedic surgery.
- •Expectation of any surgery during the study duration.
- •Subjects with any other chronic musculoskeletal disorder.
- •Subjects having history of diabetes-Type one or Type two.
- •Subjects having used any immunosuppressive drugs in the last six months-including steroids or biologics and those with history of immune system and autoimmune disorders.
- •Subjects with any hereditary disorders of bone metabolism e.g. metabolic bone diseases include osteoporosis, rickets, osteomalacia, osteogenesis imperfecta and fibrous dysplasia.
- •Presence of multiple fractures.
- •Pathologic fractures that is occurring in the presence of abnormal bone such as a tumour, cyst, or Pagets disease.
- •Delay in presentation for initial treatment of more than one week from the time of injury.
- •History of pre-existing disorders known to adversely affect bone healing e.g. Peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism.
- •History of pre-existing disorders affecting Vitamin D metabolism and or calcium phosphate homeostasis e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and or phosphate absorption.
- •Subject having known allergy to non-steroidal anti-inflammatory drugs-NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products and legumes.
- •Using natural health products e.g. capsaicin, boswellia and willow bark, creams, topical herbal oils and analgesic gels e.g. camphor and alcohol based gels during one week preceding baseline.
- •Subjects who took anabolic drugs including growth hormone-GH or Insulin like growth factor-1 IGF-1 within six months before initiation of the study.
- •Subjects who are under any massage therapy or acupuncture or any other traditional therapy.
- •Have taken any corticosteroid, indomethacin, glucosamine plus chondroitin within three months prior to the treatment period or intra-articular treatment or injections such as corticosteroids, hyaluronic acid or anti-inflammatory therapy within six months before initiation of the study.
- •Subjects with HIV Positive status.
- •Evidence or history of clinically significant in the judgment of the Investigator, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •History of Systemic Lupus Erythematous-SLE.
- •High alcohol intake greater than two standard drinks per day, smokers greater than five cigarettes per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Participation in any other trials involving investigational or marketed products within thirty days prior to the Screening Visit.
- •Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
研究者
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