| CTRI Number |
CTRI/2022/12/047852 [Registered on: 02/12/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Intervention with homoeopathy in the management of breast cancer patient in reference to quality of life |
|
Scientific Title of Study
|
To Study The Effect Of Homoeopathic Treatment To Improve Quality Of Life In Patients Of Breast Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varada Vishal Phule |
| Designation |
PhD scholar |
| Affiliation |
Bharati Vidhyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth homoeopathic hospital Pune – Satara Road, Katraj - Kondhwa Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
09820112478 |
| Fax |
|
| Email |
drvaradaphule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Jadhav |
| Designation |
Professor |
| Affiliation |
Bharati Vidhyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth homoeopathic hospital Pune – Satara Road, Katraj - Kondhwa Rd, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7387191547 |
| Fax |
|
| Email |
drarunbjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varada Vishal Phule |
| Designation |
PhD scholar |
| Affiliation |
Bharati Vidhyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth homoeopathic hospital Pune – Satara Road, Katraj - Kondhwa Rd, Dhankawadi, Pune, Maharashtra
Pune
MAHARASHTRA
411043
India |
| Phone |
09820112478 |
| Fax |
|
| Email |
drvaradaphule@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidhyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Varada Vishal Phule |
Bharati vidyapeeth homoeopathic medical college and hospital pune |
Homoeopathic Hospital , department of homoeopathic Materia medica 3rd floor, College Rd, Shriram Nagar, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA |
8976188888
drvaradaphule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine |
Dosage:- will vary according to case from Mother tincture to CM and LM potency
Frequency:- Depending on the case TDS or QID
According to the patients recovery in 12months
|
| Comparator Agent |
Control Group |
Placebo-- on conventional treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All types of Breast Cancer
Patients ready to sign the consent form
|
|
| ExclusionCriteria |
| Details |
1. No male patients
2. No patients below the age of 18 years and above 75 years
3. Patients unwilling to sign the consent for |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 5 month to collect the sample size and and then the cases will be followed every 2 weeks with Quality of life analysis over the period of one year |
the effect of the interventional group will be assessed every 15 days or 2 weeks with QAL Br 30 over the period of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
made attempts at quantifying such changes
towards improvement in quality of life in breast cancer patient
|
the effects will be assessed on QAL Br 30 every 3month i.e 3rd month, 6 month , 9 month, and 12 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/12/2022 |
| 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)
|
Not Applicable |
| 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
|
- Over a period of 6 months all new
patients who chose treatment will be approached and included
in study, once they had given informed consent. All
patients will receive the normal
standard of care offered in the institute.
- The
homeopathic group will be offered a constitutional homeopathic
treatment according to the principles of
classical homeopathy accompanying or following conventional
cancer treatment.
- Our
protocol stipulates that patient from both the conventional
and homeopathic cohort will be compared based on
the clinical data of tumour disease, staging and previous treatment. In the observational study part all cancer patients -
in adjuvant and in palliative stages - who will give their
informed consent will be included.
Comparison between
comparable patients in both cohorts regarding their QoL
as a feasibility study. We will be
measuring patient self-reports, taken at study entry and every
3 months over the course of one year.Medical
records will be taken by the treating physicians using case report forms(CRF).
Patient records (CRFs) will be checked for completeness
|