Phase II Randomized, Placebo-Controlled Study of BacoMind Bacopa Monnieri Extract for Cognitive Symptoms in Gulf War Illness

What this Trial Is About

Gulf War Illness affects multiple major organ systems and causes symptoms such as severe fatigue, memory and thinking difficulties, headaches, sleep problems, digestive issues, skin rashes, and joint pain. This phase II, double-masked, randomized, placebo-controlled study investigates whether the dietary supplement Bacopa can help manage central nervous system symptoms of Gulf War Illness. The study focuses on evaluating cognitive function and safety of Bacopa in affected Gulf War Veterans born between 1942 and 1978 who meet specific case definitions for the illness. Participants will be randomly assigned to one of two groups one receives 300 mg daily of BacoMind4 Bacopa monnieri standardized extract for 12 weeks, and the other receives a placebo that looks identical. The treatment period lasts 12 weeks, with follow-up assessments continuing for an additional 4 weeks after treatment ends. The study is conducted remotely using online tools and telephone interviews, and laboratory tests are done locally for a subgroup of participants to measure biomarkers related to brain health and inflammation. During the study, participants will be assessed at baseline, 6, 12, and 16 weeks for cognitive performance using the California Verbal Learning Test CVLT-II, physical health, vitality, sleep, pain, and symptom severity. Blood samples will be collected at baseline and at 12 weeks for some participants. Safety will be monitored through biweekly phone calls. The total observation period covers 16 weeks to evaluate both immediate and lasting effects of the treatment.

Study of Bacopa in Gulf War Illness Patients