Assessment of bone fracture healing efficacy of CL16019

Not Applicable

Completed

• Conditions: Health Condition 1: S629- Unspecified fracture of wrist andhand

• Registration Number: CTRI/2021/12/039006
• Lead Sponsor: CLS Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified