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
|
|
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
|
|
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 -raySTUDY 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/- |