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Clinical Trial Summary

The purpose of this research is to assess the safety profile and clinical benefit of Awar-Awar leaf active fraction as a complementary therapy in chemotherapy of stage IV breast cancer

Clinical Trial Description

The study uses a double blind design and randomized controlled trial that compares the safety and clinical efficacy profiles of 3 treatment groups (each consists of 97 subjects who received chemotherapy for 6 cycles). The treatment group was given FADA at a dose of 800 mg/day and 2000 mg/day compared to the placebo group. Interim analysis is carried out after 25% of the subjects completed 3 cycles of chemotherapy; whereas interim analysis II is carried out after 50% of the subjects completed 3 cycles of chemotherapy. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05033925
Study type Interventional
Source Gadjah Mada University
Contact Nanang Fakhrudin, Ph.D
Phone +62 85878502778
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 7, 2021
Completion date December 30, 2023

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