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
Study ID
NCT07467746
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • C. cicadae — DRUG
    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.
  • Control — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: control
    In addition to standard therapy (riluzole 50 mg twice daily, with or without concomitant edaravone), participants will receive a placebo matched to the investigational product in appearance, odor, and dosage form. The placebo is formulated with dextrin, caramel coloring, and other excipients, and sensory testing has confirmed that it is indistinguishable from the investigational product.
  • Experimental: C. cicadae
    In addition to standard therapy (riluzole 50 mg twice daily, with or without concomitant edaravone), participants will receive an oral preparation of the traditional Chinese medicine C. cicadae. In this study, the dose of C. cicadae is set at 0.1 g/kg/day, administered orally in three divided doses, with a maximum total daily dose of 10 g. The investigational C. cicadae preparation will be centrally prepared by the Department of Pharmacy of the Third Xiangya Hospital, Central South University.

Primary Outcome Measure

sphingolipid (SLs) levels [ Time Frame: 9 months ]

Central Contacts

Related Studies