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Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
Sponsor: LGD
Summary
A total of 170 patients male or female who are carrying SS or Sbeta0 versions of the beta globin gene will be included in the study. The subjects will be assigned with 1:1:1 ratio of either NUV001 Immediate release IR or NUV001 Gastro resistant GR or Placebo. The treatment duration of the study will be 90 days which has in total 5 visits. The primary end point of this study is to check the safety and tolerance of the orally administered nutraceutical supplement. This endpoint will be checked by assessing the Adverse events, Vital signs of the subject and the Change in hematological parameters from Baseline to Final visit.
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
2023-04-15
Completion Date
2024-11-30
Last Updated
2024-05-28
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 (8)
Aman Hospital and Research Center
Vadodara, Gujarat, India
Kingsway Hospital
Nagpur, Maharashtra, India
Sai Krupa Hospital & Research Centre
Ahmedabad, India
Thalassemia & Sickle Cell Society
Hyderabad, India
Index Medical College
Indore, India
NRSMC Hospital
Kolkata, India
Arihant Hospital
Nagpur, India
Shalinitai Meghe Hospital & Research Centre
Nagpur, India