The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

Overview

Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks. Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.

Full Title of Study: “The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

Sample size: 312

Interventions

  • Drug: Silodosin Capsules
    • Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule,1 capsule/time, bid, after breakfast and dinner.
  • Drug: Ningmitai capsule
    • Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
  • Drug: Tamsulosin
    • Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.

Arms, Groups and Cohorts

  • Active Comparator: Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo
    • Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)
  • Experimental: Silodosin Capsules combine with Ningmitai Capsules placebo
    • Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid).
  • Experimental: Silodosin Capsules combine with Ningmitai Capsules
    • Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules (Ningmitai®, 0.38 g/capsule, 4 capsules/time, tid).

Clinical Trial Outcome Measures

Primary Measures

  • International Prostate Symptom Score
    • Time Frame: 12 week
    • Changes of scores at the 12th week of treatment compared with baseline scores.

Secondary Measures

  • IPSS total score
    • Time Frame: 1, 2, 4 and 8 weeks
    • Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline scores
  • IPSS Stimulus score
    • Time Frame: 1, 2, 4 ,8 and 12 weeks
    • IPSS Stimulation Score at 1, 2, 4, 8, 12 weeks (Sum of Question 2, 4, 7) compared with baseline
  • IPSS obstruction score
    • Time Frame: 1, 2, 4 ,8 and 12 weeks
    • Changes of IPSS obstruction score (sum of question 1, 3, 5, 6) at 1, 2, 4, 8, 12 weeks after treatment compared with baseline
  • IPSS total score severity
    • Time Frame: 12 week
    • Proportion of patients with IPSS total score severity decreased by at least one grade at 12 weeks
  • Quality of life (QoL) score
    • Time Frame: 4, 8 and 12 weeks
    • Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline
  • Maximum urinary flow rate (Qmax)
    • Time Frame: 12 weeks
    • The change of Qmax at 12 weeks of treatment compared with baseline.
  • Residual urine volume (PVR)
    • Time Frame: 12 weeks
    • Changes of PVR at 12 weeks of treatment compared with baseline.
  • Prostate specific antigen (PSA)
    • Time Frame: 12 weeks
    • Changes of PSA at 12 weeks of treatment compared with baseline.
  • Prostate volume (PV)
    • Time Frame: 12 weeks
    • Changes of PV at 12 weeks of treatment compared with baseline.
  • Patient response rate
    • Time Frame: 12 weeks
    • Patient response rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% and Qmax increased by ≥ 30% compared with baseline value after treatment.
  • Proportion of patients with BPH clinical progression
    • Time Frame: 12 weeks
    • Clinical progress is defined as the first occurrence of one of the following two conditions during the trial: Acute urinary retention (AUR); Clinical diagnosis requires surgical treatment of BPH.

Participating in This Clinical Trial

Inclusion Criteria

1. Male Subjects aged 60 ~ 80 years, clinically diagnosed as benign prostatic hyperplasia. 2. Has an IPSS score ≥ 8 points at Screening and Baseline. 3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml. 4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination. 5. Subjects who can read, understand, and complete the research questionnaire. 6. Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent. Exclusion Criteria:

1. Subjects with prostate cancer or other malignant tumors. 2. Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times. 3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc. 4. Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications. 5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures. 6. Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization. 7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial. 8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial. 9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment. 10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases. 11. There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) > 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L). 12. Subjects who are allergic to the drugs or ingredients used in the test definitely. 13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.

Gender Eligibility: Male

Minimum Age: 60 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xintian Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhongguo Chen, MD, Study Chair, employee
  • Overall Contact(s)
    • Peiling Shi, +8619821240029, lc-spl@xtyyoa.com

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