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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change 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. |
| Secondary | Proportion of Bowel Movements With Bright Red Rectal Bleeding | Baseline (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. |
| Secondary | Severity Grade of Bright Red Rectal Bleeding During Defecation | Baseline (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. |
| Secondary | Severity 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. |
| Secondary | Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Utility Score | Baseline (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. |
| Secondary | Incidence of Treatment-Emergent Adverse Events Related to Auricular Press Needles and Oral Diosmin/Hesperidin | From 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). |
Source ClinicalTrials.gov
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.
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.
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