HOMOEOPATHIC IN BENIGN PROSTATIC HYPERPLASIA

Phase 2

Recruiting

Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

Registration Number: CTRI/2022/12/048226

Lead Sponsor: Dr.Manusree K M

Brief Summary: INTRODUCTION

Benign prostatic hyperplasia (BPH) is one of the most common diseases in ageing menwhich can lead to lower urinary tract symptoms (LUTS)(1) Autopsy studies haveobserved a histological prevalence of 8%, 50%, and 80% in the 4th, 6th, and 9th decadesof life, respectively Incremental increase is greater in Africa, Asia, Latin America and the Caribbeanregions there is decreased risk among the Asians compared to the western whitepopulation. 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 zonearound the urethra characterises BPH, which frequently results in lower urinary tractsymptoms such as incontinence â— Voiding symptoms - hesitancy (worsened if the bladder is very full) , poor flow(unimproved by straining) , intermittent stream â€“ stops and starts , dribbling (includingafter micturition) , sensation of poor bladder emptying , episodes of near retention.â— Storage symptoms - frequency , nocturia , urgency , urge incontinence , nocturnalincontinence (enuresis) .Risk factors of BPH include age, family history, obesity, Type 2 Diabetes, sedentary lifeand erectile dysfunction. BPH is diagnosed based on symptoms and examination afterruling 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 noninvasive method for evaluating the lower urinary tract and prostate in men and thebladder in women. Severity of symptoms can be ascertained by using InternationalProstate Symptom Score questionnaire [IPSS] Non-medicinal management were advised: To urinate when they first got the urge ; Todiscontinue tobacco, alcohol and caffeine, especially after dinner ; Not to drink a lot offluid 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, Asthese can increase BPH symptoms; to keep themselves warm by exercising regularly andto reduce stress , nervousness and tension which lead to more frequent urination; toperform Kegel exercises for strengthening pelvic muscles. BPH is associated with quality of life issues, it is not life-threatening, and it does notlead 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 CentralCouncil for Research in Homoeopathy (CCRH) had carried out preliminary study onsymptomatic BPH with positive effects. The Council then took up a multi-centre study toevaluate the usefulness of a group of pre-defined homoeopathic medicines in BPHpatients as a primary objective.The secondary objective was to check the progression of disease by evaluating changes inprostate 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 changesignificantly the PV, maintain serum PSA till 12 months of treatment but no change wasobserved in post-void residual urine, Qmax and Qavg. Medical Management in modern medicine is with alpha adrenoreceptor blockers, but itcauses reflex tachycardia, cardiac arrhythmia and retrograde ejaculation and there is amarked increase in incidence of Benign Prostatic Hyperplasia in India due to rapidurbanization and lifestyle changes. Î±1 adrenergic receptor blockers are not able tosignificantly alter PSA, and PV.There are only a few studies conducted in homoeopathy in this topic. As homoeopathy isa system on wholistic approach, we can effectively manage Benign Prostatic Hyperplasia.Most of the researches in homoeopathy reduced the lower urinary tract symptoms , but nochange was observed in post residual urine. Therefore this study is a humble effort tocheck the progress of BPH by evaluating ultrasonographic findings & Internationalprostate symptom score with homoeopathic medicines.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 38

Inclusion Criteria

Those cases above 40 years of age with symptoms of Benign Prostatic Hyperplasia.
Cases with positive ultrasound scan finding.

Exclusion Criteria

History of prostatitis , Prostate CA , Bladder CA 2.
BPH with complications.
3 .Cases with serum PSA level above 10.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Benign prostatic hyperplasia before & after homoeopathic treatment.	6 month
change in Ultra sonographical findings in patients with Benign	6 month
prostatic hyperplasia before and after treatment with homoeopathic medicines .	6 month
change in international prostate symptom score in patients with	6 month

Secondary Outcome Measures

Name	Time	Method
change in international prostate symptom score in patients with	Benign prostatic hyperplasia before & after homoeopathic treatment.

Trial Locations

Locations (1): Govt Homoeopathic Medical College, Kozhikode.
🇮🇳
Kozhikode, KERALA, India
Govt Homoeopathic Medical College, Kozhikode.
🇮🇳Kozhikode, KERALA, India
Dr Manusree K M
Principal investigator
9656606923
manusree1010@gmail.com