| CTRI Number |
CTRI/2023/06/053956 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathy In Prostatic Complaints |
|
Scientific Title of Study
|
A Comparative Study Of The Efficacy Of Homoeopathic Medicines In Cases Of Benign Prostatic Hyperplasia On The Basis Of Totality Of Symptoms And Pathological Similie |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Shankar Tiwari |
| Designation |
PG Student |
| Affiliation |
Dr. M.P.K. Homoeopathic Medical college, Hospital And Research Center |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy, Unit 1, Homoeopathy University, 10,11,12, Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur-302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
9664226823 |
| Fax |
|
| Email |
harishankartiwari9838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S N Sharma |
| Designation |
Head Of Department |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Dr MPK Homoeopathic Medical College Hospital and Research Center A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414320633 |
| Fax |
|
| Email |
raghavdrsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Shankar Tiwari |
| Designation |
PG Student |
| Affiliation |
Dr. M.P.K. Homoeopathic Medical college, Hospital And Research Center |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy, Unit 1, Homoeopathy University, 10,11,12, Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur-302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
9664226823 |
| Fax |
|
| Email |
harishankartiwari9838@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Girendra Pal Homoepathic Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoepathic Medical College Hospital and Research Center |
| Address |
Homoeopathy University, 10,11,12, Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur-302029 |
| 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 Hari Shankar Tiwari |
Dr. Girendra Pal Homoepathic Hospital and Research Center |
Department Of Organon Of Medicine And Homoeopathic Philosophy, Unit 1, Dr MPK Homoeopathic Medical College Hospital and Research Centre, Homoeopathy University, 10,11,12, Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur-302029
Jaipur
RAJASTHAN |
9664226823
harishankartiwari9838@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N40||Benign prostatic hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Medicine is selected on the basis of individualized homoeopathic approach |
| Comparator Agent |
Homoeopathic Medicine |
Medicine is selected on the basis of pathological simile |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. All males of 40 years to 80 years of age.
2. Patients giving voluntary consent for the study.
3. Cases of Benign Prostatic Hyperplasia (ICD 10- N40) with at least 3 out of following symptoms :
A. Frequency
B. Incomplete emptying
C. Nocturia
D. Intermittency
E. Urgency
F. Pain (Dysuria)
G. Haematuria
H. Straining
I. Retention of urine (not more than 24 hrs).
4. Pre diagnosed cases of Benign Prostatic Hyperplasia are under modern medicine treatment
but have no relief seeking for homoeopathic treatment. |
|
| ExclusionCriteria |
| Details |
1. Cases who refuses to give informed consent for the study.
2. Cases with intolerable pain or complicated with
obstruction.
3. Cases with any stricture which caused obstruction.
4. Cases without proper follow–up will be excluded from the
study.
5. Cases undergone bladder surgeries
6. Carcinoma of prostate
7. Complete urine retention for more than 24 hours.
8. Cases having any other complications of Benign Prostatic Hyperplasia. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained (pre & post treatment) from the IPSS |
According to the scores obtained from the IPSS at every 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Homoeopathic Medicines in cases of Benign Prostatic Hyperplasia on the basis of totality of symptoms & Pathological Similie |
12 Months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2023 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, interventional, parallel arm, comparative study of the efficacy of Homoeopathic medicines selected on the basis of the totality of symptoms and pathological similie in the cases of Benign Prostatic Hyperplasia The primary outcome measures will be according to the scores obtained (pre and post-treatment) from the IPSS (International Prostate Symptom Score). The secondary outcome is to assess the effectiveness of ’Individualized Homoeopathic Medicines’ on the basis of the totality of symptoms and ’Pathological Simlie’
Null Hypothesis: There is no significant difference in improvement in cases of BPH treated with homoeopathic medicines selected on the basis of the totality of symptoms and pathological similie Alternate Hypothesis: There is a significant difference in improvement in cases of BPH treated with homoeopathic medicines selected on the basis of the totality of symptoms and pathological similie |