Boswellia Serrata for Gulf War Illness

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Boswellia Serrata - DietarySupplement
Eligibility
18+
Male
Eligible conditions
Gulf War Illness

Study Summary

Effects of Botanical Microglia Modulators in Gulf War Illness

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Boswellia Serrata will improve 1 primary outcome and 7 secondary outcomes in patients with Gulf War Illness. Measurement will happen over the course of Average respiratory symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline..

Average cognitive symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Cognitive Symptom Severity
Average dermatological symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Dermatological Symptom Severity
Average disease severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in overall Gulf War Illness disease severity
Average fatigue severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Fatigue Severity
Average gastrointestinal symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Gastrointestinal Symptom Severity
Average mood severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Mood Symptom Severity
Average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Pain Severity
Average respiratory symptom severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
Change from baseline in Respiratory Symptom Severity

Trial Safety

Safety Estimate

1 of 3

Trial Design

10 Treatment Groups

Placebo
Resveratrol
Placebo group

This trial requires 64 total participants across 10 different treatment groups

This trial involves 10 different treatments. Boswellia Serrata is the primary treatment being studied. Participants will be divided into 9 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Resveratrol
DietarySupplement
200-600mg in capsule form by mouth every day
Nettle
DietarySupplement
435-1305mg in capsule form by mouth every day
Boswellia Serrata
DietarySupplement
400-800mg in capsule form by mouth every day
Luteolin
DietarySupplement
200-400mg in capsule form by mouth every day
Curcumin
DietarySupplement
1000-2000mg in capsule form by mouth every day
Pycnogenol
DietarySupplement
200-400mg in capsule form by mouth every day
Reishi Mushroom
DietarySupplement
1600-3200mg in capsule form by mouth every day
Fisetin
DietarySupplement
200-800mg in capsule form by mouth every day
Epimedium
DietarySupplement
1000-2000mg in capsule form by mouth every day
Placebo
DietarySupplement
in capsule form by mouth every day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resveratrol
2014
Completed Phase 3
~800
Pycnogenol
2017
Completed Phase 3
~120
Curcumin
2017
Completed Phase 4
~1030

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly average pain severity during the last two weeks of each treatment, compared to average severity during the last two weeks of placebo, as well as baseline. for reporting.

Who is running the study

Principal Investigator
J. Y.
Prof. Jarred Younger, Associate Professor
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient completes a daily report during a two week baseline period, with an 80% completion rate or higher. show original
will be automatically connected to care Veterans who are diagnosed with GWI in Kansas will be automatically connected to care. show original
The text is about the Persian Gulf War that took place from 1990 to 1991. show original
Male
Age 39-65, inclusive
without discomfort This product is meant to make venous blood draws less uncomfortable. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can gulf war illness be cured?

Add answer

Our observations suggest that an increase in the number of cases diagnosed with Gulf War illness could reflect a true increase in the illness, but many cases remain undiagnosed. These data provide an insight into the complexities of identifying an etiology for the clinical presentations.

Unverified Answer

What are common treatments for gulf war illness?

Add answer

The treatment of GWH suffering from complex multi-morbid illnesses is complex in many respects. There are no simple-bout treatments that are guaranteed to work for everyone.

Unverified Answer

What are the signs of gulf war illness?

Add answer

As compared with healthy controls, veterans with GVI are more likely to experience a history of depression, anxiety/psychosocial problems, insomnia, fatigue or low energy, decreased appetite, and increased weight. These conditions are associated with the presence of GVI; however, the reasons why they are more common among veteran populations are unclear, as is the mechanism by which GVI lead to the development of these conditions. Although a causal pathway has not been elucidated, the findings suggest that many common GVI-associated conditions might be prevented or ameliorated by identifying and treating GVI and associated conditions at the earliest indications of disease.

Unverified Answer

What is gulf war illness?

Add answer

The GI-D is the symptom complex that is most frequently encountered in Gulf War Syndrome. It is marked by fatigue, headaches, fatigue induced nausea/vomiting, and abdominal pain and tends to occur when veterans serve in the western theaters of the military operation between 1991 and 1996. There are a number of contributing factors to GWI, including the magnitude and duration of exposures to chemical agents and non-chemical agents such as biological agents, stress, trauma, sleep disturbances, nutritional deficiencies, infectious agents, and exposure to pesticides and solvents in environments of high environmental bioaerosol concentrations. These may include combat exposures, pesticides, and solvents.

Unverified Answer

How many people get gulf war illness a year in the United States?

Add answer

There is ample evidence that Gulf War Veterans have persistent and disabling symptoms of Gulf War illness that can persist indefinitely after service. Of the nearly 15,000 current Gulf War Veterans, [6% of persons with persistent Gulf War illness will have symptoms of chronic fatigue, irritable bowel syndrome, chronic pain, or depression that is unexplained, lasts more than twelve months, or persists in people with previous episodes of these symptoms] (http://www.navy.mil/news/gulf-war/). Gulf War Veterans are much less likely to have these persistent and disabling symptoms if they report that their symptoms do not cause them to seek medical care for their persistent and disabling symptoms.

Unverified Answer

What causes gulf war illness?

Add answer

Gulf War illness can appear very quickly and be associated with multiple potential environmental exposures; however, it is not fully caused by the Gulf War. Data from a recent study also implicate an active (deliberate) form of chemical weapons use involving sarin.

Unverified Answer

How serious can gulf war illness be?

Add answer

Physicians need to be aware of symptoms and signs that can be caused by gulf war illness and may be misinterpreted as acute appendicitis, to prevent delays in managing illness.

Unverified Answer

Does gulf war illness run in families?

Add answer

Allergic and autoimmune disorders, with a few exceptions, are less common in Gulf War veterans with GPI than among Gulf War-exposed relatives. Most associations observed among Gulf War veterans and their family members are limited to either a single organ involvement or family history of atopy. Further studies with larger cohorts are warranted in order to assess prevalence and predictive factors in the relatives of Gulf War veterans.

Unverified Answer

Have there been any new discoveries for treating gulf war illness?

Add answer

The lack of new findings for treating gulf war illness suggests a need for further research and research with larger numbers of patients with the illness.

Unverified Answer

How does boswellia serrata work?

Add answer

A review of reported side-effects of 'Boswellia' preparations, from two of the countries where it is native, India and the United States, shows that it is an old and unproven remedy, with adverse effects. In modern medicine, B. serrata is not a medically recognised remedy for a wide variety of conditions. Although some anecdotal reports were reported from Egypt, and are in current medical literature as 'Boswellia algida', they do not show that B. serrata has any therapeutic benefit, and in modern medicine are usually dismissed as a result of either erroneous dosage records, or fraud and/or fraudulation.

Unverified Answer

Does boswellia serrata improve quality of life for those with gulf war illness?

Add answer

A single dose of B. serrata does not improve the quality of life of patients with Gulf War or other disorders that severely affect their well-being.

Unverified Answer

Who should consider clinical trials for gulf war illness?

Add answer

[Giant cell arteritis (GCA) is a widely publicized condition, but one report suggested that there are only 2% of patients with GCA that respond to conventional treatments.(http://www.withpower.com/clinical-trials/gca/)]. As a trial with placebo-controlled and double-blinded randomized trials are the gold standard for determining treatment effects, we must consider the importance of clinical trials in this complicated condition. When we consider the results of a recent trial in India that showed no difference in outcomes for GCA patients given conventional therapy vs.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Gulf War Illness by sharing your contact details with the study coordinator.