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Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma
Sponsor: Beijing Tiantan Hospital
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
Conditions
Interventions
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).
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