Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
NCT ID: NCT05100758
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-10-01
2020-12-01
Brief Summary
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Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment
Purposes
1. To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
2. To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant
Methods A clinical trial involving patients with Tuberculosis-HIV infection
Hypothesis
1. Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
2. Lower proinflammatory cytokines are observed in people who receive active compound
Detailed Description
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Lung Tuberculosis patient with HIV Infection
Design :
Double-Blind Randomized Control Trial at the outpatient setting
Randomization Simple Randomization
Proposed Number of participants :
Using the difference between two independent means of duration to sputum conversion
1. Type 1 error 5%
2. Power of study 80%
3. Effect Size 0.5
4. Dropout rate 20% Total Participant 122
Proposed analysis
1. Time-to-event analysis using cox regression for the duration of sputum conversion and radiology resolution
2. Linear mixed model for continuous dependent variable
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Hexose Correlated Compound
The participants will be given Active Hexose Correlated Compound as a capsule 3 gram/ daily for 6 months
Active Hexoses Correlated Compound
Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.
Control Group
Participant will be given only the tuberculosis and antiretroviral treatment
No interventions assigned to this group
Interventions
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Active Hexoses Correlated Compound
Active Hexose Correlated Compound was isolated from basidiomycetes which comprise polysaccharides and amino acids.
Eligibility Criteria
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Inclusion Criteria
2. Not Pregnant
3. Diagnosed with HIV
Exclusion Criteria
2. Patient with drug-resistant
3. Severe Malnutrition
4. Refuse to be involved
18 Years
ALL
No
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Djamaludin Ma'dolangan, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Labuang Baji General Hospital
Makassar, South Sulawesi, Indonesia
Countries
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References
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Matar, C., Graham, E. 2017. Immune Modulatory Function. Clinician's Guide To AHCC, Evidence-Based Nutritional Immunotherapy, Edited by Anil D.K, Philip, C and Toshinori Ito. P.54-61.
Suknikhom W, Lertkhachonsuk R, Manchana T. The Effects of Active Hexose Correlated Compound (AHCC) on Levels of CD4+ and CD8+ in Patients with Epithelial Ovarian Cancer or Peritoneal Cancer Receiving Platinum Based Chemotherapy. Asian Pac J Cancer Prev. 2017 Mar 1;18(3):633-638. doi: 10.22034/APJCP.2017.18.3.633.
Sun B, Wakame K, Sato E, Nishioka H, Aruoma OI, Fujii H. The effect of active hexose correlated compound in modulating cytosine arabinoside-induced hair loss, and 6-mercaptopurine- and methotrexate-induced liver injury in rodents. Cancer Epidemiol. 2009 Oct;33(3-4):293-9. doi: 10.1016/j.canep.2009.07.006. Epub 2009 Aug 20.
Terakawa N, Matsui Y, Satoi S, Yanagimoto H, Takahashi K, Yamamoto T, Yamao J, Takai S, Kwon AH, Kamiyama Y. Immunological effect of active hexose correlated compound (AHCC) in healthy volunteers: a double-blind, placebo-controlled trial. Nutr Cancer. 2008;60(5):643-51. doi: 10.1080/01635580801993280.
Other Identifiers
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0307210724
Identifier Type: -
Identifier Source: org_study_id