| CTRI Number |
CTRI/2024/11/076610 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Other |
|
Public Title of Study
|
A study to see the efficacy of Low dose Radiation Therapy for control of symptoms in elderly patients suffering from Osteoartharitis. |
|
Scientific Title of Study
|
A Prospective Single arm Study to assess the Efficay of Low Dose Radiation Therapy for Control of symptoms in Elderly patients suffering from Osteoartharitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-1824 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIYA GOPAL RANJA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
Room no 1, Department of Radiotehrapy and Oncology, IPGME&R,
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
9038248098 |
| Fax |
|
| Email |
amiyagopalranja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Aloke Ghosh Dastidar |
| Designation |
Prof and Head |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
Department of Radiotherapy,
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831118494 |
| Fax |
|
| Email |
alokeghoshdastidar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suparna Kanti Pal |
| Designation |
Asssitant Professor (Co-Guide) |
| Affiliation |
IPGMER AND SSKM HOSPITAL |
| Address |
room no 4, Deparment of Radiotherapy and Oncology,
244 AJC BOSE ROAD
Kolkata
WEST BENGAL
700020
India |
| Phone |
7980253154 |
| Fax |
|
| Email |
suparna.k.pal@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital, 244 A J C Bose Road, Kolkata 700020, WB |
|
|
Primary Sponsor
|
| Name |
AMIYA GOPAL RANJA |
| Address |
DEPT OF RT , IPGMER KOLKATA |
| 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 AMIYA GOPAL RANJA |
IPGMER |
DEPT OF RADIOTHERAPY, 244 A J C BOSE ROAD
Kolkata
WEST BENGAL |
9038248098
amiyagopalranja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IPGMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M15-M19||Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RADIOTHERAPY |
3 Gy in 6 fractions , one fraction per day, 2 days a week |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 50 years or more
2. OA of any joint with pain, disability or deterioration of Quality of life not adequately controlled with exercise, tropical analgesics and single NSAIDS.
3. Kellgren – Lawrence grade 3 patients and grade 4 patients if they are not candidate for joint replacement due to concurrent morbidity making them unfit for surgery or has refused surgery due to any reason.
4. Patients who has inadequate pain control on analgesics currently on.
5. A person who understands the eligibility requirements for the study and has signed the consent form. |
|
| ExclusionCriteria |
| Details |
1.History of affected joints irradiation in the past.
2.Patient participating in other degenerative arthritis clinical trials
3.Kellgren- Lawrence grade 4 except for those included due to non- feasibility of surgery.
4. History of malignancy within the last 5 years.
5. Uncontrolled comorbid conditions.
6. History of collagen vascular diseases.
7. Patients who are scheduled for surgical treatment of that joint during the clinical trial.
8. BMI more than 39Kg/m2.
9. Known history of analgesic or substance abuse within 2 years of screening.
10. Patient having any psychiatric disease.
Fibromyalgia history or diagnosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain Relief by VAS |
4weeks,4 months,8 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in radiological status of OA |
4 months, and 12 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 2 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with High Grade osteoarthritis with significant pain even after conventional treatment and Physical therapy will be included in the study. Patients will receive Radiotherapy 3 Gy in 6 fractions two times a week. Patients will be assessed by Visual Analogue scale (VAS) at planned interval. Change in pain score would be the primary outcome while change in radiological disease status will be the secondary outcome. |