Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
Sponsor: LGD
Summary
This multicenter, randomized, double-blind, parallel-group, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of orally administered NUV001 in adult participants with sickle cell disease (HbSS or HbSβ0 genotypes). A total of 168 participants were randomized in a 1:1:1 ratio to receive NUV001 immediate-release (IR), NUV001 gastro-resistant (GR), or placebo, in addition to standard of care, for 90 days over 5 study visits. The primary objective was to assess safety and tolerability based on adverse events, clinical laboratory safety parameters, and vital signs. Exploratory secondary objectives evaluated hematologic, hemolysis, and patient-reported outcomes.
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2023-04-16
Completion Date
2024-07-03
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
NUV001 - IR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total.
NUV001 - GR
Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total.
Placebo
Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days).
Locations (9)
Aman Hospital and Research Center
Vadodara, Gujarat, India
Kingsway Hospital
Nagpur, Maharashtra, India
Shivam Hospital
Ahmedabad, India
Sai Krupa Hospital & Research Centre
Ahmedabad, India
Thalassemia & Sickle Cell Society
Hyderabad, India
Index Medical College
Indore, India
NRSMC Hospital
Kolkata, India
Arihant Multispeciality Hospital
Nagpur, India
Shalinitai Meghe Hospital & Research Centre
Nagpur, India