Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy

NCT06105827 | Completed Phase 4

• 1 other identifier: NMT16049S
• Study Type: interventional
• Target: 251
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To observe the effect of Ningmitai capsule on ureteral calculi after lithotripsy and evaluate the safety of treatment. Study Design: A multicenter, prospective, randomized, controlled clinical study design was adopted Interventions: control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group: Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group.

Conditions

Ureteral Calculi

Keywords

Ureteral calculi; Lithotripsy of ureteral calculi; Ningmitai capsule; Residual fragments

Outcome Measures

Primary Outcomes (1)

• the stone expulsion time, stone-free time

  The diminishing or vanishing of residual fragment identified by post-surgery B-ultrasound or KUB could suggest a residual fragment expulsion. Evaluation with KUB showing the shadow of calculi disappearing completely followed by a confirmation using CT could suggest a residual fragment clearance.

  From baseline to 12 weeks of treatment

Secondary Outcomes (1)

• the stone expulsion rate and stone-free rate.

  From baseline to 12 weeks of treatment

Study Arms (3)

Control group

OTHER

Give antibiotics or diclofenac sodium suppository as needed.

Drug: Control group

Ningmitai capsule

EXPERIMENTAL

Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. Course of treatment: 12 weeks

Drug: Ningmitai capsule

Combined group (Ningmitai plus tamsulosin)

EXPERIMENTAL

Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group. Course of treatment: 12 weeks

Drug: Combined group (Ningmitai plus tamsulosin)

Interventions

Control group DRUG

Give antibiotics or diclofenac sodium suppository as needed.

Also known as: diclofenac sodium

Control group

Ningmitai capsule DRUG

Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day for 12 Weeks.

Ningmitai capsule

Combined group (Ningmitai plus tamsulosin) DRUG

Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group for 12 Weeks.

Also known as: Ningmitai plus tamsulosin

Combined group (Ningmitai plus tamsulosin)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as upper urinary calculi by B-ultrasound, kidney and upper bladder (KUB), intravenous urogram (IVU) or computerized tomography (CT) before surgery with the ages between 20 and 70 years.
• Having ureteral residual fragments post URL and the diameter more than 5mm.
• The lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications.
• Willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations.

You may not qualify if:

• Pregnancy, severe diabetes, or renal insufficiency.
• Ureteral stricture and lower urinary tract obstruction.
• Concomitant treatment with α1-receptor antagonists, or Chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation.
• Unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated.
• Severe adverse events and need to withdraw from the study.

Sponsors & Collaborators

• Xintian Pharmaceutical: lead

MeSH Terms

Conditions

Ureteral Calculi

Interventions

Control Groups; Diclofenac; Tamsulosin

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Yuan Jingdong, Doctor

  Wuhan First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: October 2, 2016
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share