| CTRI Number |
CTRI/2024/04/065402 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of homoeopathic medicines along with standard care in the management of oral and oropharyngeal cancer |
|
Scientific Title of Study
|
To study the effect of homoeopathic medicines as an adjuvant in ongoing standard care of oral and oropharyngeal cancer patients an exploratory study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita |
| Designation |
PG scholar |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Room no 1
second floor
department of materia medica
Bakson homoeopathic medical college and hospital
36 B knowledge park 1
greater noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7985542822 |
| Fax |
|
| Email |
kushwahaankitaa96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita |
| Designation |
PG scholar |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Room no 1
second floor
department of materia medica
Bakson homoeopathic medical college and hospital
36 B knowledge park 1
greater noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7985542822 |
| Fax |
|
| Email |
kushwahaankitaa96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD and professor and guide |
| Affiliation |
bakson homoeopathic medical college and hospital and hospital |
| Address |
Room no 21
ground floor
Bakson homoeopathic medical college and hospital
36 B knowledge park 1 greater noida
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college
36 B Knowledge Park 1 Greater Noida Gautam Buddha Nagar U.P India 201310 |
|
|
Primary Sponsor
|
| Name |
Bakson homoeopathic medical college and Hospital and hospital |
| Address |
Room no G22
ground floor
principal office
Bakson Homoeopathic medical college and hospital 36 B knowledge park greater noida 201310 |
| Type of Sponsor |
Private medical college |
|
|
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 Ankita |
Bakson homoeopathic medical college and hospital |
out patient department (OPD)
Room no 1
ground floor
Bakson homoeopathic medical college and hospital
36 B
knowledge park 1
greater noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
7985542822
-
kushwahaankitaa96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
15 months study 6 months enrollment 6 months follow up and 3 months data analysis oral route of administration
Pill form
30 number pill size
Centesimal scale
First dose after case taking
Subsequent doses after each follow up
Potency according to the case |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
oral and oropharyngeal cancer
able to attend and participate in person during follow up |
|
| ExclusionCriteria |
| Details |
any other cancer
terminal stages or undergone reconstructive surgery
no consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected to have positive changes in University of Washington quality of life (UW QOL) score |
6 months enrollment
6 months follow up
3 months analysis
UWQOL score to be used at baseline 4 weeks 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/04/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study intends to evaluate the effectiveness of homoeopathic medicines as an adjuvant in ongoing standard care of Oral and Oropharyngeal Cancer patients. Single arm study 15 months study Scale used to assess the changes in symptoms and quality of life of Oral and Oropharyngeal cancer patients- University of Washington Quality of Life Questionnare It is expected to get positive changes in University of Washington Quality of Life Questionnare |