| CTRI Number |
CTRI/2024/04/065820 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of homoeopathic treatment in the management of Prostate enlargement. |
|
Scientific Title of Study
|
A clinical study of Individualized Homoeopathic treatment in the management of Benign Prostatic Hyperplasia using the International Prostate Symptom Score. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Bhaskar D |
| Designation |
MD (PG Scholar) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Dept. of Post-Graduate and Research Centre, Pune-Bangalore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9985920341 |
| Fax |
|
| Email |
d.saibhaskar96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Samir S Nadgauda |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Dept. of Post-Graduate and Research Centre, Pune-Bangalore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9970153078 |
| Fax |
|
| Email |
sameer.nadgauda@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sai Bhaskar D |
| Designation |
MD (PG Scholar) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Dept. of Post-Graduate and Research Centre, Pune-Bangalore Highway, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9985920341 |
| Fax |
|
| Email |
d.saibhaskar96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Pune. |
|
|
Primary Sponsor
|
| Name |
Sai Bhaskar D |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Pune-Bangalore Highway, Pune. |
| 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 Sai Bhaskar D |
BVDU Homoeopathic Medical College and Hospital |
Dept. of Practice of Medicine, Dept. of Post Graduate and Research Centre, Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital, Pune-Bangalore Highway, Pune.
Pune
MAHARASHTRA |
9985920341
d.saibhaskar96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Bharati Vidyapeeth (DTU) HMC, Pune |
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 |
Individualized Homoeopathic medicine obtained after repertorization. |
Potentized Homoeopathic medicine in the form of powder or pills. Route of Administration: Oral Selection of Potency: The selected medicine will be administered in various potencies (30,200,1M,10M) as per the need of the patient.
Duration of Intervention: 3 months. Follow ups will be taken for 3 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Patients who fulfill the case definition.
Patients aged 40 years and above will be included in the study.
Only symptomatic patients will be taken into the study.
Patients without any advanced systemic illnesses.
Patients willing to participate in the study and willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with IPSS score of greater than 20 (severe BPH) requiring surgical intervention.
Patients with Hematuria will not be taken into the study.
Patients with Vesical Calculi (Urinary bladder stones).
Patients under any other medications for BPH. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the effectiveness of Individualized Homoeopathic medicines in cases of BPH and clinically assess the outcome by using IPSS, BII (BPH Impact Index) which is a Quality of Life index, every 15 days. |
The patient will be followed up every 15 days and his IPSS score and BII scores will be recorded every 15 days to assess the effect of the given treatment and the progress of the condition. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the variation in Post-void Residual Volume (PVR volume) by USG pelvis before and after the treatment. |
Every patient will be under Homoeopathic treatment for 3 months and USG Pelvis will be recorded before and after the 3 months of treatment to assess the variation in the PVR volume. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/04/2024 |
| 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="6"
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 study to assess the effectiveness of Individualized Homoeopathic Medicines in the treatment of Benign Prostatic Hyperplasia (BPH) by using clinical assessment tools like the International Prostate Symptom Score (IPSS) and a QoL index known as the BPH Impact Index (BII) along with a Radiological investigation modality, USG Pelvis before and after the treatment to confirm the variation in the PVR volume post the 3-month treatment period.
30 patients will be enrolled into the study at BVDUHMC, Pune.
|