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Trial · NCT07899229

Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome

NCT07899229, Not applicable, Not yet recruiting, University of Medicine and Pharmacy at Ho Chi Minh City

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome. Trials, record NCT07899229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899229

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
NCT number
NCT07899229
Status
Not yet recruiting
Phases
Not applicable
Enrollment
64 participants, estimated
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions
Internal Haemorrhoids
Interventions
Auricular Indwelling Needles, Sham Auricular Indwelling Needles, Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)
First posted
2026-10-27
Last updated
2026-10-27

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Anal Pain or Discomfort During Defecation Assessed by Visual Analogue Scale (VAS)Baseline (Day 0), Day 7, and Day 14
Self-reported intensity of anal pain or discomfort experienced during defecation, measured using a continuous 100-mm (10-cm) horizontal Visual Analogue Scale (VAS) ranging from 0 ('no anal discomfort or pain') to 10 ('worst imaginable pain'). Higher scores indicate more severe anal pain or discomfort.
SecondaryProportion of Bowel Movements With Bright Red Rectal BleedingBaseline (Day 0), Day 7 (covering Week 1), and Day 14 (covering Week 2)
Calculated for each assessment period as the number of bowel movements accompanied by bright red rectal bleeding divided by the total number of bowel movements recorded in the participant's daily defecation diary, expressed as a ratio/percentage ranging from 0% to 100%. Higher values indicate a higher frequency of defecation-related bleeding.
SecondarySeverity Grade of Bright Red Rectal Bleeding During DefecationBaseline (Day 0), Day 7, and Day 14
Assessed using a 4-point ordinal symptom severity scale: Grade 0 (None: no bleeding), Grade 1 (Mild: blood streaks on toilet paper or detected only upon touching the anus), Grade 2 (Moderate: dripping blood clearly visible in the toilet bowl or coating the stool, associated with straining), and Grade 3 (Severe: jet-like or squirting bleeding filling the toilet bowl). Higher grades indicate worse bleeding severity.
SecondarySeverity Grade of Internal Hemorrhoidal Prolapse During Defecation (Goligher Classification)Baseline (Day 0), Day 7, and Day 14
Assessed using the 4-grade ordinal Goligher classification scale during defecation or straining: Grade I (No prolapse outside the anal canal), Grade II (Hemorrhoidal cushions prolapse during defecation or straining but reduce spontaneously), Grade III (Hemorrhoidal cushions prolapse during defecation or straining and require manual reduction), and Grade IV (Permanently prolapsed and irreducible). Higher grades indicate more severe hemorrhoidal prolapse.
SecondaryChange in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Utility ScoreBaseline (Day 0) and Day 14
Health-related quality of life assessed across 5 dimensions-Mobility (MO), Self-Care (SC), Usual Activities (UA), Pain/Discomfort (PD), and Anxiety/Depression (AD)-each rated on 5 severity levels (Level 1 = no problems to Level 5 = extreme problems/unable to perform). The resulting 5-digit health state profile is converted into a single summary index utility score using the validated Vietnam EQ-5D-5L value set (Mai et al., 2020), where 1.0000 represents full health (11111) and lower scores indicate worse health-related quality of life.
SecondaryIncidence of Treatment-Emergent Adverse Events Related to Auricular Press Needles and Oral Diosmin/HesperidinFrom Baseline (Day 0) through Day 14
Number and percentage of participants experiencing any treatment-emergent adverse events (TEAEs) recorded via clinical observation and patient self-report, categorized into: (1) Auricular press needle-related events: acupuncture syncope/vasovagal reaction (dizziness, hypotension, diaphoresis), intolerable local ear pain requiring needle removal, local auricular inflammation or infection (redness, swelling, heat, pain, or cellulitis), and local bleeding at the acupoint upon needle removal; and (2) Oral Daflon-related events: gastrointestinal symptoms (dyspepsia, epigastric pain, nausea, vomiting) and non-gastrointestinal events (urticaria, rash).

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25184866BACKGROUNDPubMed
32048155BACKGROUNDPubMed
32406000BACKGROUNDPubMed
38294832BACKGROUNDPubMed
39132682BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07899229

GET https://conductscience.org/api/trials/v1/NCT07899229/registered