The effect of Epilobium angustifolium L. supplement on prostate health

INTERVENTION: The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC), and participants (compliant to the inclusion and exclusion criteria) will be assigned to each of the two treatment groups (Epilobium and placebo) randomly and unpredictably by simple randomization (about 1:1 allocation ratio). The randomization code will consist of a three‐digit number as indicated in the respective Case Report Form (CRF). Treatment: one hard gastro‐resistant capsule per day containing 0.5 g of Epilobium, corresponding to 2 g of aerial parts of E. angustifolium, or placebo, for at least 5 months. Clinical visits are carried out at t1 (after 15 days of treatment) to monitor a possible occurrence of kidney and liver toxicity, t2 (after 2 months of treatment), and t3 (after 5 months of treatment) in an outpatient setting. After each clinical visit, all data are compiled in the CRF by physicians. At the baseline visit (t0) information on the sociodemographic, clinical and symptomatologic characteristics of the subjects are collected and reported in the case report form (CRF). In particular, post‐void residual (PVR) and prostate volume (and weight) obtained by prostate ultrasound; PSA, neutrophil/lymphocyte ratio (N/L) derived from blood tests analysed by Unisannio Lab (San Giorgio del Sannio, BN, Italy); urinations number during the night before the clinical visit, and IPSS score are registered. In detail, the specific analyses are shown below: t0: Ecovol, PVR (Ecormp), PSA, N/L, CRE, BR direct/indirect/total, Prothrombin, AST, ALT, CHE t1: CRE, BR direct/indirect/total, Prothrombin, AST, ALT, CHE CONDITION: Mild/moderate benign prostatic hypertrophy (BPH) ; Urological and Genital Diseases ; Hyperplasia of prostate PRIMARY OUTCOME: Post‐void residual volume (PVR or Ecormp) and prostate volume (and weight), both measured using prostatic ultrasound at baseline (t0) and after 5 months (t3) SECONDARY OUTCOME: ; Symptomatology assessed at t0, t2, t3 using the following:; 1. International Prostatic Symptoms Score (IPSS); 2. Number of urinations during the night before the clinical visit measured by a questionnaire; 3. Neutrophil/lymphocyte ratio (N/L) measured by blood analysis; 4. Prostate‐specific antigen (PSA) measured by blood analysis; INCLUSION CRITERIA: 1. Aged over 45 2. No clinically significant deviation in laboratory tests 3. History of mild BPH for at least 1 year 4. Pharmacologically treated but not controlled BPH 5. IPSS score = 8 and = 19 (moderate symptoms) 6. Prostate volume = 25cc and = 70cc 7. PVR between 30 ml and 200 ml 8. PSA = 4 ng/ml