Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer. To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 colorectal-cancer
Started Oct 2013
Shorter than P25 for early_phase_1 colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedMay 14, 2015
May 1, 2015
8 months
April 27, 2015
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutritional Status
eight weeks
Secondary Outcomes (1)
Cytotoxicity
two days
Study Arms (2)
Annona muricata extract
EXPERIMENTALAnnona muricata ethanol-soluble fraction of water extract capsule, 300 mg/day, for eight weeks
Placebo
PLACEBO COMPARATORMaltose capsule, 300 mg/day, for eight weeks
Interventions
ethanol-soluble fraction of water extract
Eligibility Criteria
You may qualify if:
- Patients with Colorectal Carcinoma
- Have undergone standard therapy
- Satisfactory haematological or biochemical functions
- Karnofsky performance status of ≥ 60%
- Willing not to take probiotic supplement during study period
You may not qualify if:
- Uncontrolled hypertension
- Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
- Physical and mental disability that renders them unable to verbally communicate
- History of recent cancers
- Pregnant, lactating, or not using adequate contraception
- Patient on other investigational drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lili Indrawati, MSc
Indonesia University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 27, 2015
First Posted
May 12, 2015
Study Start
October 1, 2013
Primary Completion
June 1, 2014
Study Completion
October 1, 2014
Last Updated
May 14, 2015
Record last verified: 2015-05