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ACTIVE NOT RECRUITING
NCT05791591
NA

Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients

Sponsor: LGD

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

NUV001 - IR

Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total

DIETARY_SUPPLEMENT

NUV001 - GR

Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total

DIETARY_SUPPLEMENT

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