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

First listed
Jul 19, 2024
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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