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Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients

NCT05033925 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2024-02-28

No results posted yet for this study

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

Conditions

  • Breast Cancer Stage IV

Interventions

DIETARY_SUPPLEMENT

FADA (active fraction of Ficus septica leaf) 800 mg/day

FADA is given twice a day (total dose of 800 per day per patient)

DIETARY_SUPPLEMENT

FADA (active fraction of Ficus septica leaf) 2000 mg/day

FADA is given twice a day (total dose of 2000 per day per patient)

OTHER

Placebo capsule

Placebo capsule is given twice a day

Sponsors & Collaborators

  • Ahmad Dahlan University

    collaborator UNKNOWN

  • Dr. Kariadi General Hospital

    collaborator UNKNOWN

  • PT Konimex

    collaborator UNKNOWN

  • LPDP, Kementerian Keuangan, Indonesia

    collaborator UNKNOWN

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • dr. Santosa, Ph.D · Dr. Kariadi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033925 on ClinicalTrials.gov