CTRI Number |
CTRI/2022/12/048226 [Registered on: 19/12/2022] Trial Registered Prospectively |
Last Modified On: |
22/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Single Arm Study |
Public Title of Study
|
HOMOEOPATHIC IN BENIGN PROSTATIC HYPERPLASIA |
Scientific Title of Study
|
A PROSPECTIVE STUDY ON THE EFFECT OF HOMOEOPATHIC
MEDICINES IN THE MANAGEMENT OF BENIGN PROSTATIC
HYPERPLASIA BY ASSESSING ULTRASONOGRAM (ABDOMEN) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manusree K M |
Designation |
Junior resident |
Affiliation |
Government Homoeopathic Medical Collage. |
Address |
Department of practice of medicine .
Government Homoeopathic Medical Collage.
Kozhikode
pin-673010
state - kerala
Kozhikode KERALA 673010 India |
Phone |
9656606923 |
Fax |
|
Email |
manusree1010@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Lizmy Jose |
Designation |
Professor (CAP) |
Affiliation |
Government Homoeopathic Medical Collage. |
Address |
Department of practice of medicine .
Government Homoeopathic Medical Collage.
Kozhikode
pin-673010
state - kerala
Kozhikode KERALA 673010 India |
Phone |
9747551747 |
Fax |
|
Email |
lizmyajith@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manusree K M |
Designation |
Junior resident |
Affiliation |
Government Homoeopathic Medical Collage. |
Address |
Department of practice of medicine .
Government Homoeopathic Medical Collage.
Kozhikode
pin-673010
state - kerala
Kozhikode KERALA 673010 India |
Phone |
9656606923 |
Fax |
|
Email |
manusree1010@gmail.com |
|
Source of Monetary or Material Support
|
GOVERNMENT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL KOZHIKODE |
|
Primary Sponsor
|
Name |
Dr.Manusree K M |
Address |
Department of Practice of Medicine,
Govt Homoeopathic Medical College, Kozhikode.
PIN - 673010
Kerala |
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 Manusree K M |
Govt Homoeopathic Medical College, Kozhikode. |
Renal OP Ground floor New block
Govt Homoeopathic Medical College and hospital, Kozhikode.
pin - 673010
Kerala Kozhikode KERALA |
9656606923
manusree1010@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee govt, homeoepathic medical college , kozhikode |
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 |
HOMOEOPATHIC MEDICINES |
Suitable homoeopathic medicines based on symptom totality dose and potency will be selected on the basis of homeopathic principles route of administration will be oral duration of treatment will be 1 year |
Comparator Agent |
not applicable |
not applicable |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Male |
Details |
1. Those cases above 40 years of age with symptoms of Benign Prostatic Hyperplasia.
2. Cases with positive ultrasound scan finding. |
|
ExclusionCriteria |
Details |
1. History of prostatitis , Prostate CA , Bladder CA
2. BPH with complications.
3 .Cases with serum PSA level above 10 |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
change in Ultra sonographical findings in patients with Benign
prostatic hyperplasia before and after treatment with homoeopathic medicines .
change in international prostate symptom score in patients with
Benign prostatic hyperplasia before & after homoeopathic treatment.
|
6 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
change in international prostate symptom score in patients with
Benign prostatic hyperplasia before & after homoeopathic treatment.
|
1 year |
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
23/12/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
23/12/2022 |
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)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
INTRODUCTION
Benign prostatic hyperplasia (BPH) is one of the most common diseases in ageing men
which can lead to lower urinary tract symptoms (LUTS)(1) Autopsy studies have
observed a histological prevalence of 8%, 50%, and 80% in the 4th, 6th, and 9th decades
of life, respectively Incremental increase is greater in Africa, Asia, Latin America and the Caribbean
regions there is decreased risk among the Asians compared to the western white
population. Genetics, diet and life style may play a role here. Globally, the estimated incidence case of BPH in 2019 was 11.26 million (95%UI: 8.79,
14.46), increasing from 5.48 million (95%UI: 4.20, 7.12) in 1990. Proliferation of both stromal and epithelial cells of the prostate in the transitional zone
around the urethra characterises BPH, which frequently results in lower urinary tract
symptoms such as incontinence â— Voiding symptoms - hesitancy (worsened if the bladder is very full) , poor flow
(unimproved by straining) , intermittent stream – stops and starts , dribbling (including
after micturition) , sensation of poor bladder emptying , episodes of near retention.
â— Storage symptoms - frequency , nocturia , urgency , urge incontinence , nocturnal
incontinence (enuresis) .
Risk factors of BPH include age, family history, obesity, Type 2 Diabetes, sedentary life
and erectile dysfunction. BPH is diagnosed based on symptoms and examination after
ruling out other possible causes. BPH is diagnosed with the digital rectal examination(DRE), cystoscopy, trans abdominal
& trans rectal prostate ultrasound and urodynamic, prostate-specific antigen(PSA),
urinalysis and culture and bladder ultrasound. Transabdominal pelvic ultrasonography is a tremendously versatile tool and it is a non
invasive method for evaluating the lower urinary tract and prostate in men and the
bladder in women. Severity of symptoms can be ascertained by using International
Prostate Symptom Score questionnaire [IPSS] Non-medicinal management were advised: To urinate when they first got the urge ; To
discontinue tobacco, alcohol and caffeine, especially after dinner ; Not to drink a lot of
fluid at once and to avoid drinking fluids within two hours of bed time; Not to take overthe-counter cold and sinus medications that contain decongestants and antihistamines, As
these can increase BPH symptoms; to keep themselves warm by exercising regularly and
to reduce stress , nervousness and tension which lead to more frequent urination; to
perform Kegel exercises for strengthening pelvic muscles. BPH is associated with quality of life issues, it is not life-threatening, and it does not
lead to prostate carcinoma. RATIONALE OF THE STUDY
Homoeopathy is the second-most widely used Complementary and alternative medicine
(CAM) in healthcare systems according to the World Health Organization. The Central
Council for Research in Homoeopathy (CCRH) had carried out preliminary study on
symptomatic BPH with positive effects. The Council then took up a multi-centre study to
evaluate the usefulness of a group of pre-defined homoeopathic medicines in BPH
patients as a primary objective.
The secondary objective was to check the progression of disease by evaluating changes in
prostate volume (PV), post-void residual urine (PVRU) and peak urine flow rates
(Qmaximum and Qaverage in mL/sec).But In this study, it is observed that homeopathic medicines were able to change
significantly the PV, maintain serum PSA till 12 months of treatment but no change was
observed in post-void residual urine, Qmax and Qavg. Medical Management in modern medicine is with alpha adrenoreceptor blockers, but it
causes reflex tachycardia, cardiac arrhythmia and retrograde ejaculation and there is a
marked increase in incidence of Benign Prostatic Hyperplasia in India due to rapid
urbanization and lifestyle changes. α1 adrenergic receptor blockers are not able to
significantly alter PSA, and PV.
There are only a few studies conducted in homoeopathy in this topic. As homoeopathy is
a system on wholistic approach, we can effectively manage Benign Prostatic Hyperplasia.
Most of the researches in homoeopathy reduced the lower urinary tract symptoms , but no
change was observed in post residual urine. Therefore this study is a humble effort to
check the progress of BPH by evaluating ultrasonographic findings & International
prostate symptom score with homoeopathic medicines. |