Overview

Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

Status:
Suspended

Trial end date:
2022-05-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Herb Spirit

Collaborator:

Carmel Medical Center

Criteria

Inclusion Criteria:

1. Males aged 18 to 75 years, Females>50 years

2. Diagnosis of "probable" or "definite" ALS according to the El Escorial revised
criteria

3. A documented history of ALS symptoms for more than 6 month prior to study enrolment,
and no more than 40 month.

4. Patients capable of understanding and signing Informed Consent.

Exclusion Criteria:

1. Patients allergic to seafood

2. Patients with forced vital capacity < 75%

3. Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.

4. Patients with cardiovascular diseases

5. Patients with diabetes

6. Patients with active peptic ulcers

7. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease,
etc).

8. Patients suffering from other chronic significant disease, malignant diseases or any
other disease that may risk the patient or interfere with the ability to interpret the
results.

9. Patients that can not sign/understand the Informed Consent Form.

10. Female patients who are pregnant or lactating

11. Patients who have received and experimental drug or have participated in a clinical
trial within 1 month prior to screening