NCT07467746

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-03-12
• Last updated: 2026-03-12