CTRI/2021/12/039006
Completed
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CLS Pvt Ltd
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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