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NOT YET RECRUITING
NCT07669662
PHASE3

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

Sponsor: Nimsai Academia

View on ClinicalTrials.gov

Summary

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.

Official title: Quadruple-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-22

Completion Date

2026-07-02

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Nimsai Herbal

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

OTHER

Placebo

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

Locations (1)

Nimsai Academia Clinical Research Center

Bursa, Turkey (Türkiye)