| CTRI Number |
CTRI/2022/07/044123 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
04/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualized Homoeopathic medicine and Chimaphila umbellata Mother tincture in the Treatment of Benign Prostatic Hyperplasia |
|
Scientific Title of Study
|
A Synopsis on Effectiveness of Individualized Homoeopathic medicines and Chimaphila umbellata Mother tincture in the treatment of Benign Prostatic Hyperplasia: An Open Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MOTHKURI PAVAN KUMAR |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block, Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7732039456 |
| Fax |
|
| Email |
pavankumarmothkuri9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block, Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD no.18, GE block, Sector 3, Salt lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
GE BLOCK , Sector 3 , SALT LAKE - 700106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MOTHKURI PAVAN KUMAR |
National Institute Of Homoeopathy |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA, OPD NO. 18, GE BLOCK , Sector 3 , SALT LAKE - 700106
Kolkata
WEST BENGAL |
7732039456
pavankumarmothkuri9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N40||Benign prostatic hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chimaphila umbellata mother tincture |
Comparator agent will be specific homoeopathic medicine Chimaphila umbellata in mother ticture. Frequency depends on the condition of the patient. All patients shall be prescibed homoeopathic medicine Chimaphila umbellata in accordance with the direction laid down by Dr. C. S. F. Hahnemann in Organon of medicine. Repetition and follow up shall be done on the basis of fundamental guidelines. The follow-up will be done monthly till 6 months from the baseline. |
| Intervention |
Individualized Homoeopathic medicine |
Intervention will be planned as administering indicated homoeopathic medicines selected on the basis of homoepathic principles in centesimal potencies. Dose and frequency depends on the condition of the patient. All patients shall be prescribed homoeopathic medicine after detailed case taking in accordance with the direction laid down by Dr. C. S. F. Hahnemann in Organon of medicine. Medicine selection, potency selection, repetition and follow up shall be done on the basis of fundamental guidelines. The follow-up will be done monthly till 6 months from the baseline. |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
a)Patients presenting symptoms of Benign Prostatic Hyperplasia with or without evidence of bladder outflow obstruction (AUASS more than 7) b)Patients suffering from cases of Benign Prostatic Hyperplasia diagnosed radiologically (USG-PELVIS) and ultrasonographical examination of Prostate weight more than 20g/20cc and RUV of more than 30ml c)Patients already undergoing regular therapy for BPH, provided the medications are stopped completely at least 2weeks prior study entry d)Male patients of all religions and of different socioeconomic status e)Patients with known but controlled systemic diseases f)Patients giving written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
a)Patients with Serum Prostate specific antigen (PSA) more than 4 nmol/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 with frequent urination or retention of urine due to systemic or neurological disorder.
e)Patient suffering from neurogenic bladder or urethral stricture |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
On the basis of score obtained from the AMERICAN
UROLOGICAL ASSOCIATION Symptom Score, cases according to intensity will be
grouped into
1-7 mildly symptomatic
8-19 moderately symptomatic
20-35 severely symptomatic.
Marked improvement – decrease of 70% or more in AUASS
Moderate improvement – decrease of 50-70% in AUASS
Mild improvement - decrease of less than 50% in AUASS |
At base line, at 3rd month and at 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The reduction of size of prostate gland and RUV, will be
recorded using USG-PELVIS |
At base line and at 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/07/2022 |
| 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 |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Benign prostatic hyperplasia (BPH) is a non neoplastic tumor ’like enlargement of the prostate. BPH is a histological diagnosis associated with unregulated proliferation of connective tissue, smooth muscle and glandular epithelium within the prostatic transition zone. BPH may cause physical compression of the urethra and result in anatomic bladder outlet obstruction (BOO) through two distinct mechanisms: First, an increase in prostate volume, termed the static component; second, an increase in stromal smooth muscle tone, termed the dynamic component. BOO, in turn, may present clinically as lower urinary tract symptoms (LUTS), urinary tract infections, acute urinary retention (AUR), renal failure hematuria, and bladder calculi. Proper case taking is done and patients will be divided into two parallel arms. 50% patients will receive Individualized homoeopathic medicine and 50% patients will receive Chimaphila Umbellata mother tincture. 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 AMERICAN UROLOGICAL ASSOCIATION Symptom Score (AUASS) gradation at baseline, third month and at 6th month. |