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NCT Number: NCT05551221

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Age range

60 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

Sample size: 312

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects with prostate cancer or other malignant tumors.
  • Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
  • Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
  • 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.
  • Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
  • Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
  • Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
  • Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
  • Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
  • Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
  • 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).
  • Subjects who are allergic to the drugs or ingredients used in the test definitely.
  • Any otherSubjects in the opinion of researchers is not suitable for inclusion.

Treatment and study plan

Silodosin Capsules

Drug

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.

Other names: Qianweitai

Ningmitai capsule

Drug

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.

Other names: Ningmitai

Tamsulosin

Drug

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.

Primary outcomes

  1. International Prostate Symptom Score（IPSS）

    Time frame: 12 week

    Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.

Secondary outcomes

  1. International Prostate Symptom Score（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. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.

  2. 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. The scores of the scale ranged from 0 to 15. The higher the score, the more severe the symptoms are.

  3. 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. The scores of the scale ranged from 0 to 20. The higher the score, the more severe the symptoms are.

  4. 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. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).

  5. 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.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.

  6. Maximum urinary flow rate (Qmax)

    Time frame: 12 weeks

    The change of Qmax at 12 weeks of treatment compared with baseline.

  7. Residual urine volume (PVR)

    Time frame: 12 weeks

    Changes of PVR at 12 weeks of treatment compared with baseline.

  8. Prostate specific antigen (PSA)

    Time frame: 12 weeks

    Changes of PSA at 12 weeks of treatment compared with baseline.

  9. Prostate volume (PV)

    Time frame: 12 weeks

    Changes of PV at 12 weeks of treatment compared with baseline.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peiling Shi

CONTACT

[email protected]

+8619821240029

Sponsors and collaborators

Lead sponsor

Xintian Pharmaceutical

Industry

Registry information

Official study title

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

Acronym: NQTIPS

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Sep 22, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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