Back to resultsThe Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (NQTIPS)
Primary Purpose
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Silodosin Capsules
Ningmitai capsule
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms focused on measuring Benign Prostatic Hyperplasia Silodosin Capsules, Ningmitai Capsule, Silodosin
Eligibility Criteria
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.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical University
- Beijing Tongren Hospital, Capital Medical UniversityRecruiting
- The First Affiliated Hospital of Guangzhou Medical University
- Peking University Shenzhen Hospital
- The Central Hospital Of WUHAN
- Wuhan No.1 Hospital
- The Second Affiliated Hospital of Soochow University
- Wuxi No.2 People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo
Silodosin Capsules combine with Ningmitai Capsules placebo
Silodosin Capsules combine with Ningmitai Capsules
Arm Description
Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
International Prostate Symptom Score（IPSS） total score
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 Stimulus score
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
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.
IPSS total score severity
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
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.
Maximum urinary flow rate (Qmax)
The change of Qmax at 12 weeks of treatment compared with baseline.
Residual urine volume (PVR)
Changes of PVR at 12 weeks of treatment compared with baseline.
Prostate specific antigen (PSA)
Changes of PSA at 12 weeks of treatment compared with baseline.
Prostate volume (PV)
Changes of PV at 12 weeks of treatment compared with baseline.
Patient response rate
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
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.
Full Information
NCT ID
NCT05551221
First Posted
September 19, 2022
Last Updated
September 21, 2022
Sponsor
Xintian Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05551221
Brief Title
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
Acronym
NQTIPS
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xintian Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Keywords
Benign Prostatic Hyperplasia Silodosin Capsules, Ningmitai Capsule, Silodosin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo
Arm Type
Active Comparator
Arm Description
Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)
Arm Title
Silodosin Capsules combine with Ningmitai Capsules placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
Silodosin Capsules combine with Ningmitai Capsules
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Silodosin Capsules
Other Intervention Name(s)
Qianweitai
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ningmitai capsule
Other Intervention Name(s)
Ningmitai
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
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 Outcome Measure Information:
Title
International Prostate Symptom Score（IPSS）
Description
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.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score（IPSS） total score
Description
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.
Time Frame
1, 2, 4 and 8 weeks
Title
IPSS Stimulus score
Description
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.
Time Frame
1, 2, 4 ,8 and 12 weeks
Title
IPSS obstruction score
Description
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.
Time Frame
1, 2, 4 ,8 and 12 weeks
Title
IPSS total score severity
Description
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).
Time Frame
12 week
Title
Quality of life (QoL) score
Description
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.
Time Frame
4, 8 and 12 weeks
Title
Maximum urinary flow rate (Qmax)
Description
The change of Qmax at 12 weeks of treatment compared with baseline.
Time Frame
12 weeks
Title
Residual urine volume (PVR)
Description
Changes of PVR at 12 weeks of treatment compared with baseline.
Time Frame
12 weeks
Title
Prostate specific antigen (PSA)
Description
Changes of PSA at 12 weeks of treatment compared with baseline.
Time Frame
12 weeks
Title
Prostate volume (PV)
Description
Changes of PV at 12 weeks of treatment compared with baseline.
Time Frame
12 weeks
Title
Patient response rate
Description
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.
Time Frame
12 weeks
Title
Proportion of patients with BPH clinical progression
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiling Shi
Phone
+8619821240029
Email
lc-spl@xtyyoa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongguo Chen, MD
Organizational Affiliation
employee
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhang, MD
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Chen, MD
Phone
+8613611257388
Email
shanchentr@gmail.com
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Zhao, MD
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shangqi Yang
Facility Name
The Central Hospital Of WUHAN
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonglian Guo, MD
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanhua Zhang, MD
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boxin Xue, MD
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ninghan Feng, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
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