| CTRI Number |
CTRI/2023/05/052992 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare between post radiological finding or functional out come in distal radius fracture. |
|
Scientific Title of Study
|
A study to evaluate the correlation between post reduction radiological findings and functional outcome in Bahaya Prokasthasthi Bhagna i.e. Distal Radius Fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Sharma |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room Number 206 Anatomy Block R.G.G.P.G Ayurvedic College and Hospital Paprola
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9896588408 |
| Fax |
01894242064 |
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Sharma |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room Number 206 Anatomy Block R.G.G.P.G Ayurvedic College and Hospital Paprola
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9896588408 |
| Fax |
01894242064 |
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amar Jeet |
| Designation |
P G Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room number 206 dept. Of Shalya Tantra R.G.G.P.G Ayurvedic Hospital Paprola
OPD 211 R.G.G.P.G Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8988890134 |
| Fax |
0189424064 |
| Email |
sanjunigasi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Government Post Graduate College and Hospital Paprola |
|
|
Primary Sponsor
|
| Name |
Principal R.G.G.P.G Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anil Kumar Sharma |
Rajiv Gandhi Government Post Graduate college and Hospital Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar Sharma |
R.G.G.P.G Ayurvedic College and Hospital Paprola |
Room number 211 Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
8988890134
01894242064
dranilpaprola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Human R.G.G.P.G Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S525||Fracture of lower end of radius. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for trail.
2.Patient of above 18 years either sex.
3.un- dispalced or minimally displaced lower end fracture of radius.
|
|
| ExclusionCriteria |
| Details |
1.Patient not willing to undergo trial or refused to give their informed consent.
2.Patient below 18 years.
3.Compound and complicated injuries.
4.Patient having metabolic diseases like uncontrolled diabetes mellitus, uncontrolled hypertension, rheumatoid arthritis, gouty arthritis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the radiological finding and functional outcome of distal radius fracture. |
9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generate feeling of well-being |
9 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the comparative study of post radiological findings and functional outcome in distal radius fracture. Thirty patients will be selected. Patients will be age group of 18 to 70. Patients will selected randomly from OPD. |