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War-Drill Model Guided Treatment of Hemorrhoids With Nimsai Herbal (NAJ)
NA trial testing Nimsai Herbal in Hemorrhoids in 300 participants. Completed in 14 November 2021.
| Lead sponsor | Nimsai Academia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 10 October 2021 |
| Primary completion | 20 October 2021 |
| Estimated completion | 14 November 2021 |
| Sites | 1 location across Turkey (Türkiye) |
Nimsai Academia
Adults 18 to 70, any sex, with Hemorrhoids or Hemorrhoidal Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hemorrhoid regression was defined as a reduction of at least one Goligher grade or a ≥75% reduction in composite hemorrhoid severity score by Day 10. (The Goligher Classification of Hemorrhoids is a 4-point scale (Grade I to IV) used for hemorrhoid severity, where higher scores indicate worse disease.)
| Group | Value | 95% CI |
|---|---|---|
| Nimsai Herbal Group | 117 | |
| Placebo Group | 33 |
Time frame: Adverse events were collected from randomization until the end of the study treatment period (Day 10), covering the entire intervention duration for each participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nimsai Herbal Group | Placebo Group |
|---|---|---|---|
| Mild GI discomfort | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT07034820 adverse events section.
This study investigated a new understanding of hemorrhoid formation and evaluated a novel systemic treatment. For 200 years, hemorrhoids were conventionally understood as isolated swollen veins. However, our new "War-Drill Model" proposes that hemorrhoids are primarily caused by blood pooling (venous congestion) in the anal region, which then secondarily leads to vascular deformation. This congestion is hypothesized to arise from either underlying health issues ("War Mode") or natural physiological and hormonal changes ("Drill Mode"). We conducted a double-blind, placebo-controlled randomized controlled trial on 300 patients with Grade 2-3 hemorrhoids to evaluate the efficacy and safety of Nimsai Herbal. This study explores the potential for "War Mode" hemorrhoids to serve as an early warning sign for other serious underlying conditions and aims to validate a novel systemic therapeutic approach.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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