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

NCT05551221 | Recruiting Phase 4

• 1 other identifier: TREC2022-17
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Keywords

Benign Prostatic Hyperplasia Silodosin Capsules; Ningmitai Capsule; Silodosin

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score（IPSS）

  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.

  12 week

Secondary Outcomes (11)

• International Prostate Symptom Score（IPSS） total score

  1, 2, 4 and 8 weeks

• IPSS Stimulus score

  1, 2, 4 ,8 and 12 weeks

• IPSS obstruction score

  1, 2, 4 ,8 and 12 weeks

• IPSS total score severity

  12 week

• Quality of life (QoL) score

  4, 8 and 12 weeks

Study Arms (3)

Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo

ACTIVE COMPARATOR

Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)

Drug: Tamsulosin

Silodosin Capsules combine with Ningmitai Capsules placebo

EXPERIMENTAL

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).

Drug: Silodosin Capsules

Silodosin Capsules combine with Ningmitai Capsules

EXPERIMENTAL

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).

Drug: Silodosin Capsules; Drug: Ningmitai capsule

Interventions

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.

Also known as: Qianweitai

Silodosin Capsules combine with Ningmitai Capsules; Silodosin Capsules combine with Ningmitai Capsules placebo

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.

Also known as: Ningmitai

Silodosin Capsules combine with Ningmitai Capsules

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.

Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xintian Pharmaceutical: lead

Study Sites (8)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The Central Hospital Of WUHAN

Wuhan, Hubei, China

NOT YET RECRUITING

Wuhan No.1 Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

NOT YET RECRUITING

MeSH Terms

Interventions

silodosin; Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Zhongguo Chen, MD

  employee

  STUDY CHAIR

Central Study Contacts

Peiling Shi

CONTACT

+8619821240029; lc-spl@xtyyoa.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: July 18, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)