Individualized Homoeopathic medicine and Chimaphila umbellata Mother tincture in the Treatment of Benign Prostatic Hyperplasia
- Conditions
- Benign prostatic hyperplasia,
- Registration Number
- CTRI/2022/07/044123
- Lead Sponsor
- National Institute Of Homoeopathy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 60
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method On the basis of score obtained from the AMERICAN At base line, at 3rd month and at 6th month UROLOGICAL ASSOCIATION Symptom Score, cases according to intensity will be At base line, at 3rd month and at 6th month grouped into At base line, at 3rd month and at 6th month 1-7 mildly symptomatic At base line, at 3rd month and at 6th month 8-19 moderately symptomatic At base line, at 3rd month and at 6th month 20-35 severely symptomatic. At base line, at 3rd month and at 6th month Marked improvement – decrease of 70% or more in AUASS At base line, at 3rd month and at 6th month Moderate improvement – decrease of 50-70% in AUASS At base line, at 3rd month and at 6th month Mild improvement - decrease of less than 50% in AUASS At base line, at 3rd month and at 6th month
- Secondary Outcome Measures
Name Time Method The reduction of size of prostate gland and RUV, will be recorded using USG-PELVIS
Trial Locations
- Locations (1)
National Institute Of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
National Institute Of Homoeopathy🇮🇳Kolkata, WEST BENGAL, IndiaDr MOTHKURI PAVAN KUMARPrincipal investigator7732039456pavankumarmothkuri9@gmail.com