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Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial

ConditionsHemorrhoidHemorrhoidal Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNimsai Academia

About this trial

This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Endoscopically confirmed Grade 2 or 3 internal hemorrhoids

Disqualifiers

Diagnosis of Grade 1 or Grade 4 hemorrhoids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nimsai Herbal

    Dietary supplement

    600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.

  • Placebo

    Other intervention

    Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Nimsai Herbal GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemorrhoid Regression Rate

Percentage of participants achieving a clinical response at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score from baseline. The composite score is the sum of clinician-assessed scores for pain, bleeding, itching, and swelling, each rated on a 0-10 Visual Analog Scale (total range 0-40).

Time frame
Day 10

Secondary outcomes

1

Visual Analog Scale Symptom Score Change

Mean change from baseline in self-reported overall hemorrhoid symptom severity at Day 10, measured on a 0-10 Visual Analog Scale (0 = no symptoms, 10 = most severe symptoms).

Time frame
Baseline to Day 10
2

Symptom Resolution Rate

Percentage of participants achieving complete resolution of all baseline hemorrhoid symptoms (composite severity score = 0) at Day 10.

Time frame
Day 10

Other outcomes

1

Incidence of Mild Gastrointestinal Discomfort

Percentage of participants reporting mild gastrointestinal adverse events (nausea, bloating, dyspepsia) during the 10-day intervention period.

Time frame
Baseline to Day 10
2

Incidence of Serious Adverse Events

Percentage of participants experiencing serious adverse events as defined by ICH GCP guidelines during the 10-day intervention period.

Time frame
Baseline to Day 10
3

Incidence of Transient Diarrhea in Diabetic Participants

Number of diabetic participants experiencing transient diarrhea resolving spontaneously within 24-48 hours during the first three days of the intervention.

Time frame
Days 1-3

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nimsai Academia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: