Clinical Research Directory

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

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

Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease

Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%. To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids. The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease