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NCT06427980
NA

Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.

Official title: Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-02-01

Completion Date

2026-03-28

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

DRUG

Chinese Herbal formula HuoXue LiShui

The intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonuri Herbal, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthami Flos, 6.0g).

DRUG

Chinese Herbal formula Placebo

The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g)

Locations (3)

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, China