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Safety and Clinical Efficacy Evaluation of Awar-awar Leaves (Ficus Septica Burm. F.) Active Fraction Capsule as Chemotherapy Complement in Stage IV Breast Cancer Patients
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
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Dr. Kariadi General Hospital
Semarang, Central Java, Indonesia
Start Date
October 25, 2021
Primary Completion Date
December 30, 2024
Completion Date
December 30, 2025
Last Updated
February 28, 2024
324
ESTIMATED participants
FADA (active fraction of Ficus septica leaf) 800 mg/day
DIETARY_SUPPLEMENT
FADA (active fraction of Ficus septica leaf) 2000 mg/day
DIETARY_SUPPLEMENT
Placebo capsule
OTHER
Lead Sponsor
Gadjah Mada University
Collaborators
NCT06064812
NCT05837533
Data Source & Attribution
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