Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07467746
PHASE2

Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the degeneration of motor neurons, leading to progressive muscle weakness and functional decline. This study is designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of an oral preparation of C. cicadae in patients with sporadic ALS and elevated plasma sphingolipid (SL) levels. Efficacy will be assessed primarily by changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and plasma SL levels.Participants who meet the eligibility criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to either the C. cicadae treatment group or the placebo group. The treatment group will receive oral C. cicadae at a dose of 0.1 g/kg/day (dry weight), administered in three divided doses per day. The placebo group will receive a matched placebo with a similar appearance and odor, administered according to the same schedule. A total of approximately 84 participants will be enrolled. The intervention period will be 6 months, and participants will be followed for a total of 9 months.

Official title: Single-center Study of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-04

Completion Date

2027-04

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

C. cicadae

The oral C. cicadae preparation will be administered at a dose of 0.1 g/kg/day, divided into three oral doses, with a maximum total daily dose of 10 g. The investigational C. cicadae preparation will be centrally prepared by the Department of Pharmacy, the Third Xiangya Hospital of Central South University.

DRUG

Control

A placebo identical to the investigational product in appearance, odor, and dosage form, formulated with dextrin, caramel coloring, and other excipients, and confirmed by sensory testing to be indistinguishable from the investigational product.