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NCT07899229

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

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if adding small ear needles to a standard oral medicine can ease symptoms in adults with early-stage internal hemorrhoids (swollen blood vessels inside the anus, grade I-II) who also have the "heat-toxin syndrome" of traditional medicine. In this pattern, people typically have bright red bleeding when passing stool, a burning feeling in the anus, dry stool, dark yellow urine, a dry throat with a bitter taste, a red tongue with a greasy yellow coating, and a rapid pulse. The trial will also learn about the safety of the ear needles. The main questions it aims to answer are: Does adding ear needles to the standard medicine lower anal discomfort or pain during bowel movements after 14 days? Does it also reduce bleeding and prolapse (hemorrhoids that come out of the anus) and improve quality of life? What side effects do participants have with the ear needles and with the medicine? Researchers will compare two groups to see if the ear needles help beyond the standard medicine alone. One group will receive ear needles and the other will receive look-alike ear patches with the needle removed (a "sham" treatment, used so that participants cannot tell which treatment they received). Both groups will take the same medicine, diosmin/hesperidin (Daflon 500 mg), and receive the same diet and lifestyle advice. Participants will: Take Daflon 500 mg tablets for 14 days Have ear needles or sham patches placed on seven points of one ear on Day 0 and Day 7 (switching ears each time), and have them removed on Day 5 and Day 12 Press the needles or patches gently at least 3 times a day for 1 minute each time Visit the clinic on Day 0, Day 7 and Day 14 to report their pain (on a 0-10 scale), bleeding and prolapse, and to complete a quality-of-life questionnaire (Day 0 and Day 14) Report any side effects to the study team

Official title: Evaluating the Efficacy of Auricular Indwelling Needles as an Adjunct to Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) in Goligher Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome: A Randomized, Participant-Blind, Sham-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-20

Completion Date

2027-05-31

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Internal Haemorrhoids

Interventions

DEVICE

Auricular Indwelling Needles

Sterile, single-use intradermal auricular press needles (Khanh Phong / Tianxie brand, dimensions 0.22 x 1.3 mm, approved by the Vietnam Ministry of Health under Decision No. 287/BYT-YDCT) are inserted perpendicularly to a depth of 1.3 mm after 70% isopropyl alcohol disinfection at 7 auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Treatment consists of 2 cycles over 14 days: Cycle 1 on the right ear (inserted on Day 0, removed on Day 5, followed by a 2-day rest period) and Cycle 2 on the left ear (inserted on Day 7, removed on Day 12). Participants press the plastered acupoints at least 3 times per day for 1 minute per session to elicit mild soreness, warmth, or distension (Deqi sensation).

DEVICE

Sham Auricular Indwelling Needles

Identical adhesive patches (Khanh Phong / Tianxie brand) from which the stainless-steel microneedle tip has been completely removed so that no skin penetration or mechanical needle stimulation occurs. Following 70% isopropyl alcohol disinfection, the sham patches are adhered to the exact same 7 unilateral auricular acupoints-Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17)-on the right ear for Cycle 1 (Day 0 to Day 5) and the left ear for Cycle 2 (Day 7 to Day 12). Participants are instructed to press the patches at least 3 times per day for 1 minute per session, identical to the active intervention group.

DRUG

Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)

Oral film-coated tablets containing 500 mg of Micronized Purified Flavonoid Fraction (450 mg micronized Diosmin and 50 mg Hesperidin; Daflon 500 mg, manufactured by Servier, France; Vietnam Drug Administration registration No. 3109/QLD-DK). Administered orally for 14 days per the Vietnam Ministry of Health acute hemorrhoidal regimen (Decision No. 5013/QD-BYT): 3 tablets twice daily (3,000 mg/day) for the first 4 days (Days 1 - 4), followed by 2 tablets twice daily (2,000 mg/day) for the next 3 days (Days 5 - 7), and 1 tablet twice daily (1,000 mg/day) for the subsequent 7 days (Days 8 - 14). All participants also receive standardized dietary and lifestyle counseling (high-fiber diet, 1.5 - 2 L water/day, avoidance of spicy food/alcohol/prolonged sitting or straining).

Inclusion Criteria: * Male or female outpatients aged 18 years or older attending Le Van Thinh Hospital. * Confirmed diagnosis of Grade I or Grade II internal hemorrhoids according to the Goligher classification (based on the 2020 Vietnam Ministry of Health Guidelines and the 2024 American Society of Colon and Rectal Surgeons \[ASCRS\] Clinical Practice Guidelines), verified by clinical examination and rigid anoscopy. * Presence of both of the following clinical symptom thresholds at baseline: 1. Anal pain or discomfort during defecation with a Visual Analogue Scale (VAS) score \>= 3 points (on a 0-10 scale). 2. Bright red rectal bleeding during defecation, with or without spontaneously reducible hemorrhoidal prolapse. * Confirmed diagnosis of Traditional Medicine Heat-Toxicity Syndrome (Hoi chung Nhiet doc, per the 2020 Vietnam Ministry of Health Guidelines and the 2020 Chinese Association of Integrative Medicine Guidelines for Hemorrhoids), requiring fulfillment of all three of the following conditions: 1. Primary symptoms: Presence of BOTH (a) bright red bleeding during defecation and (b) anal burning sensation; (c) prolapsed hemorrhoidal mass outside the anus may be present or absent. 2. Secondary symptoms: Presence of at least 2 of the following 3 symptoms: (a) dry, hard stools; (b) scanty dark-yellow urine; (c) dry throat and bitter taste in the mouth. 3. Tongue and pulse signs: Red tongue body with a yellow, greasy coating, and a slippery, rapid pulse (mach hoat sac). * Naive to auricular press needle therapy (never previously treated with auricular press needles). * Voluntarily agrees to participate in the study and signs the written informed consent form. Exclusion Criteria: * Indication for surgical hemorrhoidectomy or urgent procedural intervention, including Grade III or Grade IV internal hemorrhoids, large symptomatic external hemorrhoids, thrombosed hemorrhoids, or strangulated/incarcerated hemorrhoids. * History or current presence of other colorectal or anal conditions causing hematochezia, including colorectal polyps, colorectal cancer, inflammatory bowel disease (Crohn's disease, ulcerative colitis), diverticulitis, anal fissure, or anal fistula. * History or presence of cognitive impairment or psychiatric disorders, including bipolar disorder, anxiety disorder, depressive disorder, or schizophrenia. * Congenital or acquired auricular abnormalities or ear conditions, including unilateral or bilateral congenital microtia/anotia, congenital deafness, auricular chondritis, or active skin infection/dermatitis on the auricle. * Known hypersensitivity or allergy to metal needles, adhesive tape, or any component of the auricular press needles, severe needle phobia, or a history of acupuncture syncope (needle fainting). * Severe systemic comorbidities (uncontrolled cardiovascular or respiratory diseases), history of malignancy or active cancer treatment, or unexplained weight loss. * Hepatic or renal dysfunction, known hypersensitivity to Diosmin, Hesperidin, or any excipient of Daflon 500 mg, or pregnancy. * Concurrent participation in another interventional clinical trial involving medications or medical procedures.