Back to resultsClinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Primary Purpose
Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Erectile Dysfunction
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sildenafil
Ningmitai capsule
Ningbitai capsule + sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Prostatitis With Chronic Pelvic Pain Syndrome focused on measuring Ningmitai capsule, Sildenafil, Chronic prostatitis/chronic pelvic pain syndrome, Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria: Male patients aged 20-50 years; Have a fixed sexual partner and have a normal sexual life; Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4), or accompanied by lower urinary tract symptoms (micturition score > 4), lasting more than 3 months; Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points; It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine; Volunteer subjects and agree to sign informed consent. Exclusion Criteria: Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week; Patients with varicocele or tumors in prostate, bladder and urethra; Have received TURP, TUIP, bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia; Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level; Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; Those who are known to be allergic to the drugs tested in this study or some of their components
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Western Medicine Section (Sildenafil)
Traditional Chinese medicine group (Ningmitai capsule)
Combined group (Ningmitai capsule + sildenafil)
Arm Description
Sildenafil is an effective and commonly used oral PDE5 inhibitor in the treatment of ED. In this study, the subjects in the western medicine group will take sildenafil citrate orally, 25mg/capsule, once a night, one capsule each time for 4 weeks.
Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of Urinary and reproductive system disease (eg. CP/CPPS, ED) in China for more than twenty years. In this study, the subjects took Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals for 4 weeks.
In this study, the subjects will take Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 4 capsules each time three times a day, after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.
Outcomes
Primary Outcome Measures
The response rate of patients at 4 weeks of treatment.
The response rate is defined as the proportion of patients whose NIH-CPSI pain score decreased by at least 4 points and IIEF-5 score or EHS score increased at 4 weeks of treatment.
Secondary Outcome Measures
NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment
National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.
At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.
Change value = IIEF-5 score after treatment-baseline IIEF-5 score IIEF-5 contains five questions about erectile status, confidence in maintaining erection and satisfaction with sexual intercourse, and is widely used to diagnose ED, judge the severity of ED and evaluate the effectiveness of drug treatment for ED. Total score 25 points, the lower the score, the more serious the symptoms.
The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment
Erectile hardness score (EHS) is a commonly used method to evaluate the severity of ED in clinic. They are divided into grade I (severe ED), grade II (moderate ED), grade III (mild ED) and grade IV (normal erectile function).
Full Information
NCT ID
NCT06064448
First Posted
September 26, 2023
Last Updated
October 9, 2023
Sponsor
Xintian Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT06064448
Brief Title
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Official Title
A Prospective, Multicenter, Randomized, Parallel and Positive Drug-controlled Clinical Study of Ningbitai Capsule in the Treatment of Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction.
Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted.
Interventions:
① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously.
③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.
Detailed Description
Sample size: 214
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Erectile Dysfunction
Keywords
Ningmitai capsule, Sildenafil, Chronic prostatitis/chronic pelvic pain syndrome, Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Western Medicine Section (Sildenafil)
Arm Type
Active Comparator
Arm Description
Sildenafil is an effective and commonly used oral PDE5 inhibitor in the treatment of ED.
In this study, the subjects in the western medicine group will take sildenafil citrate orally, 25mg/capsule, once a night, one capsule each time for 4 weeks.
Arm Title
Traditional Chinese medicine group (Ningmitai capsule)
Arm Type
Experimental
Arm Description
Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of Urinary and reproductive system disease (eg. CP/CPPS, ED) in China for more than twenty years.
In this study, the subjects took Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals for 4 weeks.
Arm Title
Combined group (Ningmitai capsule + sildenafil)
Arm Type
Experimental
Arm Description
In this study, the subjects will take Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd., Sinopharm Zhunzi Z20025442), 0.38 g/capsule, 4 capsules each time three times a day, after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Western Medicine Section
Intervention Description
Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ningmitai capsule
Other Intervention Name(s)
Traditional Chinese medicine group
Intervention Description
The subjects took Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, after meals, and continued to treat for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ningbitai capsule + sildenafil
Other Intervention Name(s)
Combined group
Intervention Description
The subjects took Ningmitai capsule orally, 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals. Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.
Primary Outcome Measure Information:
Title
The response rate of patients at 4 weeks of treatment.
Description
The response rate is defined as the proportion of patients whose NIH-CPSI pain score decreased by at least 4 points and IIEF-5 score or EHS score increased at 4 weeks of treatment.
Time Frame
Treatment for 4 weeks
Secondary Outcome Measure Information:
Title
NIH-CPSI sub-score and its change value compared with baseline period at 2 weeks and 4 weeks of treatment
Description
National Institutions of Health Chronic Prostatitis Symptom Index（NIH-CPSI，0~43 points） consists of three subscales. The first part is pain symptoms, which consists of questions 1~4 (0~21 points), and evaluates the location, frequency and severity of pain. The second part is urination symptoms, which consists of questions 5~6 (0 ~ 10 points), and evaluates the severity of incomplete urination and frequent urination; The third part is to evaluate the impact on the quality of life, which consists of questions 7~9 (0~12 points).The higher the score, the more serious the symptoms of chronic prostatitis.
Time Frame
Treatment for 2 and 4 weeks
Title
At 2 and 4 weeks of treatment, IIEF-5 score and its change compared with baseline.
Description
Change value = IIEF-5 score after treatment-baseline IIEF-5 score IIEF-5 contains five questions about erectile status, confidence in maintaining erection and satisfaction with sexual intercourse, and is widely used to diagnose ED, judge the severity of ED and evaluate the effectiveness of drug treatment for ED. Total score 25 points, the lower the score, the more serious the symptoms.
Time Frame
Treatment for 2 and 4 weeks
Title
The evaluation grade of EHS of patients at 2 weeks and 4 weeks of treatment
Description
Erectile hardness score (EHS) is a commonly used method to evaluate the severity of ED in clinic. They are divided into grade I (severe ED), grade II (moderate ED), grade III (mild ED) and grade IV (normal erectile function).
Time Frame
Treatment for 2 and 4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients aged 20-50 years;
Have a fixed sexual partner and have a normal sexual life;
Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4), or accompanied by lower urinary tract symptoms (micturition score > 4), lasting more than 3 months;
Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points;
It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine;
Volunteer subjects and agree to sign informed consent.
Exclusion Criteria:
Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week;
Patients with varicocele or tumors in prostate, bladder and urethra;
Have received TURP, TUIP, bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level;
Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis;
Those who are known to be allergic to the drugs tested in this study or some of their components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deng Chunhua, Doctor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
671013
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
We'll reach out to this number within 24 hrs