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

Phase 4

Recruiting

• Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
• Interventions: Drug: Silodosin Capsules; Drug: Tamsulosin; Drug: Ningmitai capsule

• Registration Number: NCT05551221
• Lead Sponsor: Xintian Pharmaceutical

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.

Detailed Description

Sample size: 312

Study Timeline

• Study Start: 2022-07-18
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-23
• Primary Completion: 2023-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 312

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silodosin Capsules combine with Ningmitai Capsules placebo	Silodosin Capsules	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).
Silodosin Capsules combine with Ningmitai Capsules	Ningmitai capsule	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).
Silodosin Capsules combine with Ningmitai Capsules	Silodosin 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).
Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo	Tamsulosin	Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score（IPSS）	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 Outcome Measures

Name	Time	Method
International Prostate Symptom Score（IPSS） total score	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.
IPSS total score severity	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).
Quality of life (QoL) score	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.
IPSS Stimulus score	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.
IPSS obstruction score	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.
Maximum urinary flow rate (Qmax)	12 weeks	The change of Qmax at 12 weeks of treatment compared with baseline.
Prostate specific antigen (PSA)	12 weeks	Changes of PSA at 12 weeks of treatment compared with baseline.
Prostate volume (PV)	12 weeks	Changes of PV at 12 weeks of treatment compared with baseline.
Patient response rate	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.
Residual urine volume (PVR)	12 weeks	Changes of PVR at 12 weeks of treatment compared with baseline.
Proportion of patients with BPH clinical progression	12 weeks	Clinical progress is defined as the first occurrence of one of the following two conditions during the trial: 1. Acute urinary retention (AUR); 2. Clinical diagnosis requires surgical treatment of BPH.

Trial Locations

Locations (8)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Central Hospital Of WUHAN; 🇨🇳 Wuhan, Hubei, China

Wuxi No.2 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Wuhan No.1 Hospital; 🇨🇳 Wuhan, Hubei, China

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China