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CTRI Number  CTRI/2019/12/022476 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On: 18/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Radius Fracture Management 
Scientific Title of Study   EVALUATION OF COMBINED EFFECT OF ARJUNA KSHEERAPAKA AND POSTERIOR SLAB WITH STANDARD OF CARE IN RADIUS FRACTURE - A COMPARITIVE CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-AIMS-2019-AYUR-163  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Athira Krishnan 
Designation  PG Scholar 
Affiliation  Amrita school of Ayurveda 
Address  Department of Shalya tantra(Surgery) Amrita School of Ayurveda Amritapuri Amrita Vishwa Vidhyapeetham Kollam Kerala India

Kollam
KERALA
690525
India 
Phone  8281478398  
Fax  04762899681  
Email  athirakrishnan3500@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rabinarayan Tripathy 
Designation  HOD and Professor 
Affiliation  Amrita School of Ayurveda 
Address  Department of Shalya tantra(Surgery) Amrita School of Ayurveda Amritapuri Amrita Vishwa Vidhyapeetham Kollam Kerala India

Kollam
KERALA
690525
India 
Phone  8129292391  
Fax  04762899681  
Email  drrabi73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Athira Krishnan 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Shalya tantra(Surgery) Amrita School of Ayurveda Amritapuri Amrita Vishwa Vidhyapeetham Kollam Kerala India

Kollam
KERALA
690525
India 
Phone  8281478398  
Fax  04762899681  
Email  athirakrishnan3500@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetham, Kollam, Kerala, India 
 
Primary Sponsor  
Name  Dr Athira Krishnan 
Address  Department of Shalya tantra(Surgery) Amrita School of Ayurveda Amritapuri Amrita Vishwa Vidyapeetham Kollam Kerala India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Athira Krishnan  Amrita Ayurveda Hospital  Amrita Ayurveda Hospital Department of Shalya tantra(Surgery) Amrita School Of Ayurveda Amritapuri Amrita Vishwa Vidyapeetham Kollam Kerala India
Kollam
KERALA 
8281478398
04762899681
athirakrishnan3500@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIMS-2019-AYUR-163  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M848||Other disorders of continuity of bone,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arjuna Ksheerapaka and posterior Slab in Radius Fracture  Arjuna Ksheerapaka given internally 96 ml for 45 days on empty stomach along with Posterior Slab 
Comparator Agent  Posterior Slab in Radius Fracture  Posterior Slab for 45 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Simple Radius Fracture diagnosed by X Ray .
Fracture with a history of trauma within 72 hours.
Age from 20 - 40 years. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain – Visual analogue scale
Swelling – Measuring the circumference in cm and comparing with normal limb.
Tenderness
Deformity – Visible/Palpable/Absence of deformity.
Test of union
Absence of mobility between fragments.
Absence of pain on Angulation stress.
Radiological criteria for union
Visible callus on X-Ray
Continuity of Bone trabeculae
 
periodical clinical assesment done in 0th, 30th and 45th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Pain – Visual analogue scale
Swelling – Measuring the circumference in cm and comparing with normal limb.
Tenderness
Deformity – Visible/Palpable/Absence of deformity.
Test of union
Absence of mobility between fragments.
Absence of pain on Angulation stress.
Radiological criteria for union
Visible callus on X-Ray
Continuity of Bone trabeculae
 
periodical clinical assesment done in 0th, 30th,45th day. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

     .

 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/-

 

 
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