Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06064448
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-09-26
Brief Title:
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Sponsor:
Xintian Pharmaceutical
Organization:
Xintian Pharmaceutical
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CPCPPS 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 25mgcapsule once a night one capsule each time for 4 weeks
② Chinese medicine group Ningmitai capsule Ningmitai capsule 038 gcapsule 3 times a day 4 capsules each time taken after meals for 4 weeks continuously
③ Combination group Ningmitai capsule sildenafil Ningmitai capsule 038 gcapsule 3 times a day 4 capsules each time taken after meals Sildenafil citrate 25mgcapsule once a night one capsule each time was taken continuously for 4 weeks
Study Design A multicenter prospective randomized and positive drug-controlled clinical study design was adopted
Interventions
① Western medicine group sildenafil Sildenafil citrate 25mgcapsule once a night one capsule each time for 4 weeks
② Chinese medicine group Ningmitai capsule Ningmitai capsule 038 gcapsule 3 times a day 4 capsules each time taken after meals for 4 weeks continuously
③ Combination group Ningmitai capsule sildenafil Ningmitai capsule 038 gcapsule 3 times a day 4 capsules each time taken after meals Sildenafil citrate 25mgcapsule once a night one capsule each time was taken continuously for 4 weeks
Detailed Description:
Sample size 214
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None