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Clinical trial to assess the safety and efficacy of CV-HFG01 tablets in management of hyperuricemia and associated pain in gout

Volume No : (2019) Volume: 07 Issue : 36 Year : 2019 Page No: 72-78

Authors : Veena Deo, Bhushan Shrikhande, Gayatri Ganu, Ninad Naik

Abstract :

Background: Test product “CV-HFG01 tablet” was developed by Clinic Health Pvt. Ltd. for the management of hyperuricemia and associated pain in gout.

Aim: The main objective of the study was to assess the safety and efficacy of “CV-HFG01 tablet” in patients with hyperuricemia and gout.

Materials and Methods: It was an open label, single arm, prospective, and interventional clinical study conducted on 30 subjects which were advised to consume 1 tablet of CV-HFG01 twice daily orally with water for 3 months along with the ongoing treatment for gout apart from conventional drug for a hypouricemic agent. The assessment for mean decreases in serum uric acid levels from baseline; improvement of the clinical symptoms and improvement in SF-36 health survey score, patients global assessment, physicians global assessment, and performance of patient on pain visual analog scale were evaluated to determine the efficacy of the test product.

Results: Treatment of CV-HFG01 demonstrated significant reduction in uric acid levels, pain, and stiffness in patients suffering from gout. There was a significant reduction in doses of conventional treatment by CVHFG01 tablets. Of 30 subjects, 16 subjects were on conventional medicine for pain relief, alongside of CV-HFG01 tablets, of which 9 (56.25 %) showed reduction in doses at day 30 and 3 (18.75 %) at day 90.

Conclusion: Thus, CV-HFG01 is safe and effective alternative in the management of gout

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