Rocklin nutritional supplement company IGH Naturals Inc. has won approval to conduct a clinical study on the effectiveness of its food product to ease harsh side effects of chemotherapy in cancer patients.
The clinical study will document the effectiveness of its Humolyte formula to ease oral ulcers and gastrointestinal distress in chemotherapy patients.
“Through this research, we aim to bring a tangible improvement to the quality of life for cancer patients by addressing some of the most debilitating side effects of chemotherapy," said Dr. Sourabh Kharait, CEO and founder of IGH, in a news release.
The company currently sells Humolyte and other products, but they are considered foods or supplements, said Rich Foreman, chief operating officer with IGH Naturals. With a successful study, the company will be able to make claims about Humolyte’s effectiveness in chemotherapy patients.
The study was approved to begin by the Biomedical Research Alliance of New York LLC for an Institutional Review Board effort.
IGH will supply 40 patients with six weeks of products for free to do the research, Foreman said. The company is reaching out to oncologists to find study candidates. The study will evaluate the efficacy of Humolyte for hydration before and during chemotherapy.
IGH recommends patients start using Humolyte before treatment begins because once side effects occur, they are hard to turn around, Foreman said. The company posits that Humolyte will protect the digestive system and aid in hydration to avoid nausea, vomiting and diarrhea associated with chemotherapy.
IGH's products are currently considered foods, as opposed to drugs. The company's synthesized oligosaccharides are designated "generally recognized as safe," or GRAS, for oral consumption, by the Food and Drug Administration.
Kharait launched the company in 2017 to provide hydration and supplements to medical patients without using an intravenous drip. In addition to being a internal medicine medical doctor, Kharait also has a doctorate in cellular and molecular pathology.
Humolyte is for patients with a vulnerable gut who need hydration. The company has two patents for Humolyte in its use to help patients avoid dehydration because of diarrhea, nausea and vomiting.
The clinical trial is open to participation for all eligible patients in the United States.
Kharait is a nephrologist, or kidney doctor, who practices locally. IGH in 2019 began selling its novel magnesium-rich electrolyte hydration mix, Magnak, a nutritional supplement to improve muscle performance and reduce cramps in athletes.
It sells its products on Amazon. The company is small, with only a few employees, Foreman said. Its supplements and formulas are contract manufactured for the company. Foreman declined to disclose IGH's revenue.
