Radius Fracture Management

Phase 3

Not yet recruiting

• Conditions: Other disorders of continuity of bone,

• Registration Number: CTRI/2019/12/022476
• Lead Sponsor: Dr Athira Krishnan

Brief Summary

PROPOSED TITLE – EVALUATION OF COMBINED EFFECT OF ARJUNA KSHEERAPAKA AND POSTERIOR SLAB WITH STANDARD OF CARE IN RADIUS FRACTURE – A COMPARITIVE CLINICAL TRIAL

Name of scholar – Dr. Athira krishnan, Department – Shalya Tantra(Surgery)

ABSTRACT

BACKGROUND AND PURPOSE:

Radius and ulna fracture consisted of 44% and Radius fractures accounts for 25% of fractures in paediatric population and 18%of all fracture in elderly. Children and adolescents are at a particular risk for distal radius fracture and studies suggested that this could be the result of increase in participation of sports related activities in paediatric population.23% of all sports fracture occurred in distal part of  radius Patient who sustain a dominant wrist injury are likely to report functional impairment across a wide range of activity. Many fractures are complicated by impaired healing and it negatively affects the patients quality of life and may require a second surgery to stabilise the fracture and stimulate bone functions. In such conditions early healing is a need to prevent further complications affecting quality of life of the patient. This arise the need of an advanced study that promotes early healing of fracture. Thus an ayurvedic study with Arjuna ksheerapaka is proposed to assess the efficacy in healing of fracture.

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The main objective of the study is;

Primary objective is to evaluate the effect of Arjuna ksheerapaka in bone healing.

Secondary objective is to evaluate the effect of Arjuna ksheerapaka in reducing pain, swelling, tenderness, loss of function and callus formation on X -ray**STUDY DESIGN**

The study is expected to be done as an open labeled Double armed, clinical trial in which 30 patients, fulfilling the inclusion criteria will be selected. Patients will be clinically examined and X ray radiograph  will be used for diagnosis. After confirmation patients will be registered in the OPD of Amrita Ayurveda College Hospital.  The patients will be recruited into two groups – Group A and Group B by simple random sampling with 15 patients in each group.

  —  Clinical examination of the patient will be thoroughly examined both subjectively and objectively according to the clinical Performa.

—  Group A – The patients will receive POP Posterior slab along with Arjuna ksheerapaka internally(96 ml) once daily for 45 days.

Group B – The patients will receive Available standard of care that is POP Posterior slab for 45 days.

·               Assessment will be done on 0th day, 30 th day and on 45th day.

·       STATISTICAL METHODS:  The data will be statistically analysed and interpreted using Z test.

APPROXIMATE BUDGET: ?  50,000/-

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-12-18
• Study Start: 2019-12-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Simple Radius Fracture diagnosed by X Ray . Fracture with a history of trauma within 72 hours. Age from 20.

Exclusion Criteria

• 1.)Other diagnosed osteogenic pathologies like Bone cyst, Osteomalacia, Bone tumor, Osteomyelitis, Rickets etc 2.)Compound, Comminuted and other fractures that need surgical interventions.
• 3.)Fracture of both Radius and Ulna.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain – Visual analogue scale	periodical clinical assesment done in 0th, 30th and 45th day.
Swelling – Measuring the circumference in cm and comparing with normal limb.	periodical clinical assesment done in 0th, 30th and 45th day.
Tenderness	periodical clinical assesment done in 0th, 30th and 45th day.
Deformity – Visible/Palpable/Absence of deformity.	periodical clinical assesment done in 0th, 30th and 45th day.
Test of union	periodical clinical assesment done in 0th, 30th and 45th day.
Visible callus on X-Ray	periodical clinical assesment done in 0th, 30th and 45th day.
Continuity of Bone trabeculae	periodical clinical assesment done in 0th, 30th and 45th day.
Absence of mobility between fragments.	periodical clinical assesment done in 0th, 30th and 45th day.
Radiological criteria for union	periodical clinical assesment done in 0th, 30th and 45th day.
Absence of pain on Angulation stress.	periodical clinical assesment done in 0th, 30th and 45th day.

Secondary Outcome Measures

Name	Time	Method
Pain – Visual analogue scale	Swelling – Measuring the circumference in cm and comparing with normal limb.

Trial Locations

Locations (1)

Amrita Ayurveda Hospital; 🇮🇳 Kollam, KERALA, India

Amrita Ayurveda Hospital

🇮🇳Kollam, KERALA, India

Dr Athira Krishnan

Principal investigator

8281478398

athirakrishnan3500@gmail.com