| CTRI Number |
CTRI/2024/05/067640 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine In The Treatment of Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
Role of Individualised Homoeopathic Medicine Using Fifty Millesimal Potency In The Treatment of Benign Prostatic Hyperplasia: An Open Label Clinical 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 |
Jyotidarshanee |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14,Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector-3, Salt lake, Kolkata-700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
8763016501 |
| Fax |
|
| Email |
jyotidarshanee7401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14,Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector-3, Salt lake, Kolkata-700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14,Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector-3, Salt lake, Kolkata-700106
WEST BENGAL
INDIA
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector-3, Salt lake, Kolkata-700106
|
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block, Sector-3, Salt lake, Kolkata-700106
|
| Type of Sponsor |
Government 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 Jyotidarshanee |
National Institute of Homoeopathy |
Department of Organon of Medicine, OPD No 14, National Institute of Homoeopathy, GE Block, Sector-3, Salt lake, Kolkata-700106
Kolkata
WEST BENGAL |
8763016501
jyotidarshanee7401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine in fifty millesimal potency |
Intervention is planned as to administer indicated individualised homoeopathic medicine in ascending fifty millesimal potency as per directions given in aphorism 248 and its footnote in Organon of Medicine, Total duration of treatment 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
A) Patients of age group of 40-80 years
B) Patients presenting symptoms of Benign prostatic hyperplasia with or without evidence of
bladder outflow obstruction with AUASS more than 7
C) Patient suffering from cases of Benign Prostatic Hyperplasia diagnosed radiologically (USG Pelvis) and Ultrasonographic examination of prostate weight more than 20 g or 20 cc and RUV of more than 30ml
D) Male patients of all religions and of different socioeconomic status
E) Patients with known but controlled systemic diseases
F) Patients who are willing to give consent to participate in the study
G) Patient who can read and/or understand Hindi or Bengali or English |
|
| ExclusionCriteria |
| Details |
A) Patients with Serum Prostate specific antigen (PSA) more than 4 nmol per mL to rule out suspected prostatic malignancy
B) Cases suffering from uncontrolled systemic illness or life-threatening conditions
C) Patient suffering from complete retention of urine for more than 24hrs
D) Patient having any psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AMERICAN UROLOGICAL ASSOCIATION Symptom Score (AUASS) |
Baseline, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| USG for prostate size and residual urine volume |
Baseline and 6th month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
27/05/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
A. Study will be conducted in OPD of National Institute of Homoeopathy for a duration of 12 months, wherein, each patient will be followed up for 6 months. B. Inclusion and exclusion criteria will be followed. C. After obtaining written consent, preliminary screening will be done and the eligible patients will be recruited in the study. D. A detailed and thorough case taking of each patient will be done. E. AUASS, USG for prostate size and residual urine volume will be assessed at baseline. F. Clinical examinations and relevant investigation will be done as per the need of each case. G. Final selection of single individualised medicine shall be based on case taking in adherence with the standard homoeopathic guidelines, symptom similarity, analysis and evaluation of the symptom totality and after conclusion with Materia Medica. H. Indicated medicines will be dispensed to the patients from the pharmacy of NIH in fifty millesimal potency. I. Each enrolled case will be followed up monthly, USG-Pelvis will be done at the baseline and at 6th month to assess/compare the size of the prostate gland and RUV. The assessment of the outcome of the treatment will be done using AUASS gradation at baseline, third month and at 6th month. |