Impact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With G04CB02 on the Clinical Improvement of ALS Patients

Who is this study for? Patients with amyotrophic lateral sclerosis
What treatments are being studied? Liposomed polyphenols resveratrol+Curcumin+Isocaloric Diet+G04CB02
Status: Completed
Location: See location...
Intervention Type: Other, Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Amyotrophic lateral sclerosis (ALS) is a disease of an inflammatory nature, which causes progressive muscle weakness associated with cognitive and behavioural disorders. Pathogenically, it is characterised by loss of oxidative control, excitotoxicity due to excess glutamate and intestinal dysbiosis. In the absence of curative treatment, the aim of the study is to assess the impact at a clinical level of the combination of liposomed polyphenols to improve their effectiveness, with the drug G04CB02 which shows great anti-ALS properties by Molecular Topology methodology. A prospective, longitudinal, mixed, analytical, experimental and double-blind study is proposed, with a population sample of 60 patients distributed randomly in 30 patients in the intervention group who will receive treatment for 4 months, and 30 patients in the control group who will receive a placebo for the same period. The assessment will be at time 0, and at 2 months and 4 months after treatment, with functional, cognitive and behavioural tests, and of the state of inflammation and oxidation; and at time 0 and 4 months, of the intestinal microbiota.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• All ALS patients, over 18 years of age and with a clear diagnosis and symptomatology of ALS since at least 6 months.

Locations
Other Locations
Spain
José Enrique de la Rubia Ortí
Valencia
Time Frame
Start Date: 2021-11-20
Completion Date: 2023-02-04
Participants
Target number of participants: 90
Treatments
Experimental: Intervention group
30 patients will be given the combination of resveratrol and curcumin liposomed with G04CB02, in a single daily dose for 4 months.
Placebo_comparator: Control group
30 patients, who will receive a placebo with the same dosage pattern and for the same period of time. The placebo will consist of water with sucrose replacing the liposomal polyphenols, and a soft capsule of microcrystalline methylcellulose instead of G04CB02. Both the packaging and the capsule format will be identical to those of the treatment administered in the intervention group
Sponsors
Leads: Fundación Universidad Católica de Valencia San Vicente Mártir

This content was sourced from clinicaltrials.gov

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