Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06511050
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Chronic Fatigue Syndrome
  • Long Covid
  • Myalgic Encephalomyelitis
  • Post-treatment Lyme Disease Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lumbrokinase — DIETARY_SUPPLEMENT
    Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Study Details

This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts: * Long Covid (LC) * Post-treatment Lyme disease syndrome (PTLDS) * Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Key Dates

Start date
Oct 9, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Long Covid
    Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
  • Experimental: Post-treatment Lyme Disease Syndrome
    Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
  • Experimental: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
    Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Primary Outcome Measure

EuroQol Visual Analogue Scale Score (EQ-VAS) [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New YorkNew York10029
Mackenzie Doerstling, MPH
David Putrino (PRINCIPAL_INVESTIGATOR)

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