Abstract
Objective To evaluate the efficacy of Ningmitai capsule (NMT), a traditional Chinese medicine, alone or combined with tamsulosin, in promoting residual stone fragment clearance after Ureteroscopic Holmium Laser Lithotripsy (Ho:YAG-URS). Methods In this multicenter, prospective, randomized controlled trial, 222 patients with distal ureteral residual fragments (3.18 ± 1.14 mm) post-Ho:YAG-URS were assigned to three groups: control (no medication), NMT (0.38g × 4 capsules, 3 times/day), or NMT + tamsulosin (0.4 mg/day). Primary outcome was the stone-free rate (SFR) at 4 weeks. Secondary outcomes included stone expulsion rate, stone-free time, and expulsion time. Results At 4 weeks, SFRs were 76.19% (control), 92.21% (NMT; p = 0.023 vs. control), and 98.91% (combination; p < 0.001 vs. control). The combination group achieved significantly shorter stone-free time (6.37 ± 2.25 vs. 15.82 ± 21.62 days, p < 0.0001) and expulsion time (2.27 ± 1.17 vs. 6.64 ± 10.56 days, p < 0.0001) compared to the control group. No drug-related adverse events were reported. Conclusions NMT significantly accelerates residual fragment expulsion post-Ho:YAG-URS, with synergistic effects observed when combined with tamsulosin. This study demonstrates that patients can benefit from Ningmitai capsules alone or combined with tamsulosin, particularly for small fragments where alpha-blockers show limited efficacy.
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Supplementary Material for: Ningmitai Capsule Facilitates Residual Fragment Clearance after Ureteroscopic Holmium Laser Lithotripsy: A Multicenter Randomized Controlled Trial
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CONSORT 2025 checklist of information to include when reporting a randomised trial
Section/Topic
Item
No Checklist item
Reported on page
No
Title and abstract
Title and structured
abstract
1a Identification as a randomised trial Page 1, Line 3
1b Structured summary of the trial design, methods, results, and conclusions Page 1~2, Line 22~37
Open science
Trial registration 2 Name of trial registry, identifying number (with URL) and date of registration Page 3, Line 77~80
Protocol and statistical
analysis plan
3 Where the trial protocol and statistical analysis plan can be accessed Page 10, Line
255~256
Data sharing 4 Where and how the individual de-identified participant data (including data dictionary), statistical
code, and any other materials can be accessed
Page 10, Line
255~256
Funding and conflicts
of
interest
5a Sources of funding and other support (eg, supply of drugs), and role of funders in the design,
conduct, analysis, and reporting of the trial
Page 9, Line 245
5b Financial and other conflicts of interest of the manuscript authors Page 9, Line 242
Introduction
Background and
rationale
6 Scientific background and rationale Page 2~3, Line 40~71
Objectives 7 Specific objectives related to benefits and harms Page 3, Line 68~71
Methods
Patient and public
involvement
8 Details of patient or public involvement in the design, conduct, and reporting of the trial Page 4~5, Line
110~123
Trial design 9 Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and
framework (eg, superiority, equivalence, non-inferiority, or exploratory)
Page 3, Line 75
Page 6, Line 146~147
Changes to trial
protocol
10 Important changes to the trial after it commenced including any outcomes or analyses that were not
prespecified, with reason
not applicable
Trial setting 11 Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted Page 3, Line 76~77
Eligibility criteria 12a Eligibility criteria for participants Page 4, Line 86~93
12b If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons,
physiotherapists)
not applicable
CONSORT 2010 checklist Page 1
Section/Topic
Item
No Checklist item
Reported on page
No
Title and abstract
Title and structured
abstract
1a Identification as a randomised trial Page 1, Line 3
1b Structured summary of the trial design, methods, results, and conclusions Page 1~2, Line 22~37
Open science
Trial registration 2 Name of trial registry, identifying number (with URL) and date of registration Page 3, Line 77~80
Protocol and statistical
analysis plan
3 Where the trial protocol and statistical analysis plan can be accessed Page 10, Line
255~256
Data sharing 4 Where and how the individual de-identified participant data (including data dictionary), statistical
code, and any other materials can be accessed
Page 10, Line
255~256
Funding and conflicts
of
interest
5a Sources of funding and other support (eg, supply of drugs), and role of funders in the design,
conduct, analysis, and reporting of the trial
Page 9, Line 245
5b Financial and other conflicts of interest of the manuscript authors Page 9, Line 242
Introduction
Background and
rationale
6 Scientific background and rationale Page 2~3, Line 40~71
Objectives 7 Specific objectives related to benefits and harms Page 3, Line 68~71
Methods
Patient and public
involvement
8 Details of patient or public involvement in the design, conduct, and reporting of the trial Page 4~5, Line
110~123
Trial design 9 Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and
framework (eg, superiority, equivalence, non-inferiority, or exploratory)
Page 3, Line 75
Page 6, Line 146~147
Changes to trial
protocol
10 Important changes to the trial after it commenced including any outcomes or analyses that were not
prespecified, with reason
not applicable
Trial setting 11 Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted Page 3, Line 76~77
Eligibility criteria 12a Eligibility criteria for participants Page 4, Line 86~93
12b If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons,
physiotherapists)
not applicable
CONSORT 2010 checklist Page 1
Intervention and
comparator
13 Intervention and comparator with sufficient details to allow replication. If relevant, where additional
materials describing the intervention and comparator (eg, intervention manual) can be accessed
Page 4~5, Line
112~115
Outcomes 14 Prespecified primary and secondary outcomes, including the specific measurement variable (eg,
systolic blood pressure), analysis metric (eg, change from baseLine, final value, time to event),
method of aggregation (eg, median, proportion), and timepoint for each outcome
Page 5, Line 132~142
Harms 15 How harms were defined and assessed (eg, systematically, nonsystematically) Page 6, Line 143~144
Sample size 16a How sample size was determined, including all assumptions supporting the sample size calculation Page 6, Line 146~151
16b Explanation of any interim analyses and stopping guideLines not applicable
Randomisation
Sequence generation 17a Who generated the random allocation sequence and the method used Page 4, Line 102~103
17b Type of randomisation and details of any restriction (eg, stratification, blocking and block size) Page 4, Line 102~108
Allocation
concealment
mechanism
18 Mechanism used to implement the random allocation sequence (eg, central computer/telephone;
sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence
until interventions were assigned
Page 4, Line 102~108
Implementation 19 Whether the personnel who enrolled and those who assigned participants to the interventions had
access to the random allocation sequence
Page 4, Line 102~108
Blinding 20a Who was blinded after assignment to interventions (eg, participants, care providers, outcome
assessors, data analysts)
not applicable
20b If blinded, how blinding was achieved and description of the similarity of interventions not applicable
Statistical methods 21a tatistical methods used to compare groups for primary and secondary outcomes, including harms Page 6, Line 152~157
21b Definition of who is included in each analysis (eg, all randomised participants), and in which group Page 4, Line 107~108
21c How missing data were handled in the analysis not applicable
21d Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing
prespecified from post hoc
not applicable
Results
Participant flow,
including
flow diagram
22a For each group, the numbers of participants who were randomly assigned, received intended
intervention, and were analysed for the primary outcome
Page 6, Line 146~151
22b For each group, losses and exclusions after randomisation, together with reasons Page 6, Line 146~151
Recruitment 23a Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms Page 3, Line 82
23b If relevant, why the trial ended or was stopped not applicable
Intervention and
comparator delivery
24a Intervention and comparator as they were actually administered (eg, where appropriate, who
delivered the intervention/ comparator, how participants adhered, whether they were delivered as
intended [fidelity])
Page 4~5, Line
110~123
CONSORT 2010 checklist Page 2
comparator
13 Intervention and comparator with sufficient details to allow replication. If relevant, where additional
materials describing the intervention and comparator (eg, intervention manual) can be accessed
Page 4~5, Line
112~115
Outcomes 14 Prespecified primary and secondary outcomes, including the specific measurement variable (eg,
systolic blood pressure), analysis metric (eg, change from baseLine, final value, time to event),
method of aggregation (eg, median, proportion), and timepoint for each outcome
Page 5, Line 132~142
Harms 15 How harms were defined and assessed (eg, systematically, nonsystematically) Page 6, Line 143~144
Sample size 16a How sample size was determined, including all assumptions supporting the sample size calculation Page 6, Line 146~151
16b Explanation of any interim analyses and stopping guideLines not applicable
Randomisation
Sequence generation 17a Who generated the random allocation sequence and the method used Page 4, Line 102~103
17b Type of randomisation and details of any restriction (eg, stratification, blocking and block size) Page 4, Line 102~108
Allocation
concealment
mechanism
18 Mechanism used to implement the random allocation sequence (eg, central computer/telephone;
sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence
until interventions were assigned
Page 4, Line 102~108
Implementation 19 Whether the personnel who enrolled and those who assigned participants to the interventions had
access to the random allocation sequence
Page 4, Line 102~108
Blinding 20a Who was blinded after assignment to interventions (eg, participants, care providers, outcome
assessors, data analysts)
not applicable
20b If blinded, how blinding was achieved and description of the similarity of interventions not applicable
Statistical methods 21a tatistical methods used to compare groups for primary and secondary outcomes, including harms Page 6, Line 152~157
21b Definition of who is included in each analysis (eg, all randomised participants), and in which group Page 4, Line 107~108
21c How missing data were handled in the analysis not applicable
21d Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing
prespecified from post hoc
not applicable
Results
Participant flow,
including
flow diagram
22a For each group, the numbers of participants who were randomly assigned, received intended
intervention, and were analysed for the primary outcome
Page 6, Line 146~151
22b For each group, losses and exclusions after randomisation, together with reasons Page 6, Line 146~151
Recruitment 23a Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms Page 3, Line 82
23b If relevant, why the trial ended or was stopped not applicable
Intervention and
comparator delivery
24a Intervention and comparator as they were actually administered (eg, where appropriate, who
delivered the intervention/ comparator, how participants adhered, whether they were delivered as
intended [fidelity])
Page 4~5, Line
110~123
CONSORT 2010 checklist Page 2
S. Karger AG, Basel
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