Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A Prospective, Randomized, Double-blind, Multicenter Clinical Study

Clinical trial title：Efficacy and safety of Ningmitai capsule alone or combined with celecoxib in the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): A prospective, randomized, double-blind, multicenter clinical study
Version number/date：1.1/2023-10-09
Principal investigator：Zhou Huiliang
Main research units：The First Affiliated Hospital of Fujian Medical University
Clinical trial start and end dates：2023/07/01-2025/12/31
Objective: To evaluate whether Ningmitai capsule(NMT) alone or combined with Celecoxib for 6 weeks is more effective than Celecoxib in improving pain symptoms of CP/CPPS patients.
Study type: Interventional study
Total sample size:240
Inclusion criteria:
（1）Age: male patients aged 18-60 years; （2）Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; （3）Negative bacterial in urine before and after prostate massage; （4）Voluntarily participate in the trial. 10、Exclusion criteria:
Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks;
Patients who have received prostate surgery and treatment;
Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic treatment in the early stage;
Pelvic pain and voiding dysfunction caused by non-prostatitis factors.
Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS;
Significant adverse events in clinical or laboratory examination.
Allergic to the components of the test drugs or sulfa;
Previous active peptic ulcer / bleeding;
A birth plan within the past 8 months;
Legally disabled patients or psychiatric patients;
Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment；
Participating in other clinical trials;
Considered unsuitable for enrollment by the investigator. 11、Interventions:
（1）Ningmitai group （2）Celecoxib group （3）Combination group

Start Date01 Dec 2023

Sponsor / Collaborator

Guiyang Xintian Pharmaceutical Co., Ltd.

NCT05551221 / RecruitingPhase 4

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

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.

Start Date18 Jul 2022

Sponsor / Collaborator

Beijing Farber Xintian Pharmaceutical Technology Co., Ltd.

NCT06064448 / CompletedPhase 4

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

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.

Start Date19 Mar 2019

Sponsor / Collaborator

Guiyang Xintian Pharmaceutical Co., Ltd.

100 Clinical Results associated with NingMiTai

100 Translational Medicine associated with NingMiTai

100 Patents (Medical) associated with NingMiTai

Literatures (Medical) associated with NingMiTai

01 Jul 2022·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Systematic review and Meta-analysis of efficacy and safety of Ningmitai Capsules in treatment of urinary tract infection].

Review

Author: Lyu, Jian ; Xie, Yan-Ming ; Wang, Zi-Qiang ; Li, Jiang-Bin

This study aims to evaluate the effectiveness and safety of Ningmitai Capsules in the treatment of urinary tract infection.To be specific, articles on the treatment of urinary tract infection with Ningmitai Capsules were retrieved from China National Know-ledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, Cochrane Library, PubMed, EMbase, and Web of Science(from establishment to October 2021).Eligible randomized controlled trials(RCTs) were screened out, and ROB and RevMan 5.3 of Cochrane were employed for data integration and Meta-analysis.Finally, 17 articles were included, involving 1 972 cases, with 1 045 in the experimental group and 927 in the control group.The Meta-analysis results are as follows.Ningmitai Capsules combined with conventional antibiotics was superior to sensitive antibiotics alone in the treatment of acute pyelonephritis in aspects of clinical cure rate(RR=1.94, 95%CI[1.58, 2.37], P<0.000 01), reduction in the count of red blood cells in the urine(MD=-3.22, 95%CI[-3.23,-3.21], P<0.000 01), decrease in the count of white blood cells in the urine(MD=-2.34, 95%CI[-2.59,-2.10], P<0.000 01), and time for the disappearance of the symptoms(MD_(time for urinary tract irritation disappeared)=-2.19, 95%CI[-2.69,-1.68], P<0.000 01; MD_(time for waist aches disappeared)=-3.58, 95%CI[-4.20,-2.97], P<0.000 01; MD_(time for heating disappeared)=-0.57, 95%CI[-0.81,-0.33], P<0.000 01).The combination of either cephalosporin or quinolone with Ningmitai Capsules can improve clinical cure rate of acute pyelonephritis(RR_(combined with cephalosporin)=1.94, 95%CI[1.56, 2.42], P<0.000 01; RR_(combined with quinolone)=1.91, 95%CI[1.16, 3.15], P=0.01).The clinical cure rate(RR=1.91, 95%CI[1.47, 2.49], P<0.000 01) of diabetes complicated with urinary tract infection by Ningmitai Capsules was higher than that by quinolones.The clinical cure rate(RR=1.22, 95%CI[1.09, 1.37], P=0.000 5) of non-gonococcal urethritis by Ningmitai Capsules combined with conventional tetracycline and macrolide antibiotics was higher than that by conventional antibiotics.Ningmitai Capsules combined with conventional antibiotics/Ningmitai Capsules alone was superior to conventional antibiotics alone in the treatment of urinary tract infection in terms of the clinical cure rate(RR=1.35, 95%CI[1.17, 1.56], P<0.000 1) and incidence of adverse reactions(RR=0.32, 95%CI[0.15, 0.68], P=0.003), particularly the combination with quinolone antibiotics(RR=1.30, 95%CI[1.04, 1.61], P=0.02).The main adverse reactions were mild gastrointestinal discomfort, nausea, vomiting, and dry mouth.In summary, Ningmitai Capsules combined with conventional sensitive antibiotics/Ningmitai Capsules alone can improve the clinical cure rate of patients with urinary tract infection.Ningmitai Capsules combined with conventional sensitive antibiotics can significantly reduce the time for symptom disappearance of acute pyelonephritis and down-regulate the counts of red and white blood cells in the urine compared with antibiotics alone, and no serious adverse reactions have been found.However, in light of the low proportion of quality eligible articles, experiments with rigorous design, large sample size, and complete outcome in-dexes should be carried out in the future to verify the clinical efficacy and safety of Ningmitai Capsules in the treatment of urinary tract infection.

01 Apr 2022·UrolithiasisQ2 · MEDICINE

Ningmitai capsule promotes calculi expulsion after RIRS for 10–20-mm upper urinary stones: a multicenter, prospective, randomized controlled trial

Q2 · MEDICINE

Article

Author: Qiao, Qingdong ; Xu, Changbao ; Dou, Zhongling ; Zhang, Xiaofan ; Cheng, Hepeng ; Wang, Wenhao ; Zhao, Xinghua ; Sun, Jiantao ; Wang, Ruofan ; Yang, Dengke ; Zhang, Jianguo ; Wang, Xiaofu ; Zhang, Huiming ; Li, Wuxue ; Hao, Bin ; Zhou, Bo ; Zhu, Chaoyang ; Xiao, Fei ; Lv, Wenwei

AbstractTo evaluate the efficacy and safety of the use of Ningmitai capsule as an adjunctive stone expulsion therapy after RIRS. All patients were diagnosed with upper urinary tract calculi measuring 10–20 mm. The patients who successfully underwent RIRS were randomly assigned to the NMT capsule group (Ningmitai capsule, 1.52 g, three times daily) or the control group for 4 weeks based on the random number table method. The primary endpoints were the stone expulsion rate (SER) and stone-free rate (SFR). The average stone expulsion time (SET), average stone-free time (SFT) and complications were recorded. Between July 2, 2019, and December 17, 2020, 220 participants successfully underwent RIRS across 6 centers; 123 of them were randomized according to the exclusion criteria, and 102 (83%) were included in the primary analysis. The SERs on the 3rd, 7th, 14th and 28th days were significantly increased in the NMT capsule group compared with the control group (78.95% vs. 31.11%, 92.98% vs. 55.56%, 94.74% vs. 64.44%, 100% vs. 82.22%, respectively, p < 0.05). The SFRs on the 3rd and 7th days were not different (p > 0.05), while those on the 14th and 28th days were higher in the NMT capsule group (63.16% vs. 24.44% and 92.98% vs. 68.89%, p < 0.05). The average SET and average SFT of the NMT capsule group were remarkably shorter than those of the control group (p < 0.001). During the follow-up period, there were no significant differences in urine RBC counts between the two groups (p > 0.05). The urine WBC counts of the NMT capsule group were significantly lower than those of the control group on the 14th day (p = 0.011), but there was no difference on the 3rd, 7th or 28th day (p > 0.05). The analgesic aggregate of the NMT capsule group was also much lower (p = 0.037). There were no significant differences in adverse events (p > 0.05), and they improved significantly without sequelae. This study indicated that NMT capsules can significantly promote stone clearance and are more effective and safer for upper urinary calculi after RIRS.Trial registration Chinese Clinical Trial Registration No. ChiCTR1900024151.Date of registration June 28, 2019.

12 Dec 2021·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Herb-separated moxibustion on navel combined with Ningmitai capsule for non-liquefaction semen with dampness and heat diffusing downward: a randomized controlled trial].

Article

Author: Song, Jing-Yan ; Xia, Qing-Chang ; Ma, Yu-Xia ; Zhou, Yue

OBJECTIVETo compare the clinical therapeutic effect between herb-separated moxibustion on navel combined with Ningmitai capsule and simple Ningmitai capsule for non-liquefaction semen with dampness and heat diffusing downward.METHODSA total of 66 patients with non-liquefaction semen of dampness and heat diffusing downward were randomized into an observation group (33 cases, 2 cases dropped off) and a control group (33 cases, 2 cases dropped off). In the control group, Ningmitai capsule was given orally 3 times a day. On the basis of the control group, herb-separated moxibustion on navel was applied in the observation group, 5 moxa-cones each time, once a week. The 4-time treatment was as one course and totally 3 courses were required in the both groups. Before and after treatment, the semen quality indexes (time of semen liquefaction, sperm viability, total sperm motility, number of progressive motility sperms, sperm concentration and semen volume) and TCM syndrome score were observed, the clinical therapeutic efficacy and spouse pregnancy rate were evaluated in the two groups.RESULTSAfter treatment, the time of semen liquefaction was shortened (P<0.05), the sperm viability, total sperm motility, number of progressive motility sperms, sperm concentration and semen volume were increased in the both groups (P<0.05); the time of semen liquefaction in the observation group was shorter than the control group (P<0.05), the sperm viability, total sperm motility and number of progressive motility sperms in the observation group were superior to the control group (P<0.05). After treatment, the TCM syndrome score was decreased compared before treatment in the observation group (P<0.05), and that in the observation group was lower than the control group (P<0.05). The total therapeutic effect rate and spouse pregnancy rate were 93.5% (29/31) and 67.7% (21/31) in the observation group, which were higher than 71.0% (22/31) and 41.9% (13/31) in the control group respectively (P<0.05).CONCLUSIONHerb-separated moxibustion on navel combined with Ningmitai capsule can effectively treat non-liquefaction semen with dampness and heat diffusing downward, improve the clinical symptoms, semen quality and spouse pregnancy rate, the therapeutic effect is superior to simple oral Ningmitai capsule.

100 Deals associated with NingMiTai

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Indication	Country/Location	Organization	Date
Prostatitis	CN	Guiyang Xintian Pharmaceutical Co., Ltd.	30 Nov 2002
Urinary Tract Infections	CN	Guiyang Xintian Pharmaceutical Co., Ltd.	30 Nov 2002

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