| CTRI Number |
CTRI/2023/09/057781 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in Fibroadenosis |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in the treatment of Fibrocystic Breast Disease : an open label prospective observational 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 |
Quhely Ghosh |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no-18, Block-GE, Sector-III, Salt lake,Kolkata, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003989386 |
| Fax |
|
| Email |
kuhely2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Ghelani Uchat |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Department of Homoeopathic Materia Medica, OPD no-18, Block-GE, Sector-III, Saltlake, Kolkata, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
ushauchat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Quhely Ghosh |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no-18, Block-GE, Sector-III, Salt lake,Kolkata, 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7003989386 |
| Fax |
|
| Email |
kuhely2@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy,Block-GE, Sector-III, Salt lake,Kolkata, 700106 |
|
|
Primary Sponsor
|
| Name |
Quhely Ghosh |
| Address |
National Institute of Homoeopathy, Block -GE, Sector III, Salt lake, Kolkata, West Bengal 700106 |
| 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 Quhely Ghosh |
National Institute of Homoeopathy |
Department of Homoeopathic Materia Medica, OPD no-18, Block-GE, Sector-III, Salt lake,Kolkata, 700106
North Twentyfour Parganas
WEST BENGAL |
7003989386
kuhely2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N602||Fibroadenosis of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicine will be prescribed according to the symptom similarity for a period of 6 months. Medicine will be prescribed in both centesimal and 50 millesimal potency. For Centesimal potency 4 medicated globules number 30 will be considered as single dose. For 50 millesimal potency, 1 medicated globule of poppy seed size will be mixed with 100 ml of distilled water, 12 drops of rectified spirit will be added for preservation. The preparation will be considered as 16 doses. Patient will be advised to give 10 strokes before consuming each dose. Doses and potency required for each case and repetition will be as per homoeopathic principle and individual requirement of the case. Route of administration will be orally. Total duration of therapy will be 6 months for each patient.
|
| Comparator Agent |
NIL |
As because this is a single arm non-randomized study, comparator group is not required. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients suffering from FBD for atleast 6 months.
2.Women within the age group of 20-50 years.
3.Patients who have discontinued other medication for FBD for atleast 3 months prior to
the treatment. |
|
| ExclusionCriteria |
| Details |
1.Infection or inflammation of the breast including cysts, tumours or galactocele.
2.Any congenital abnormality of breast.
3.Extra-mammary pain related to any other disorders of the chest.
4.Patients suffering from malignant condition of the breast.
5.Pregnant and lactating women.
6.Patients under treatment of OCP, hormone replacement therapy.
7.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life
threatening illness.
8.Substance abuse and/or dependence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The assessment of the outcome of the treatment will be done by the changes that occur
in the scoring of The Lucknow Cardiff breast nodularity scale |
Baseline & 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Daily Breast Pain
Charting |
1st & 6th month |
|
|
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)
|
25/09/2023 |
| 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="1"
Months="0"
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 is a
non-randomized, open label, single arm, prospective, observational clinical
trial to show the effectiveness of Individualized Homoeopathic Medicine in the
treatment of fibrocystic breast disease. Patients will be enrolled by following
the inclusion and exclusion criteria. Diagnosis will be made by Ultrasonography
of both breasts. After proper case taking according to the guidelines given by
Master Hahnemann, Individualized Homoeopathic Medicine will be prescribed to
each and every patient after repertorization and consult with materia medica. The
outcome of this study will be measured by the changes that occur in the
scoring of The Lucknow Cardiff breast nodularity scale and Daily Breast Pain
Charting. Lucknow Cardiff breast nodularity scale will be measured at baseline
and 6th month and Daily Breast Pain Charting will be done at 1st
and 6th month. At the end of the study the result will be analysed
with proper statistical technique to show whether the changes made by
Individualized Homoeopathic medicine are significant or not. The level of significance
will be fixed at p less than 0.05. |