Sammensætning til behandling af skrumpelever og leverkræft (SB-1121) (SB-1121)
Sammensætning til behandling af skrumpelever og leverkræft
The composition treats cirrhosis and hepatocellular carcinoma (Hcc) at an early stage. The product is extracted from herbs, including Adenosma glutinosum extract, Eclipta prostrata extract, Phyllanthus urinaria extract, Impatiens balsamina extract, Ascorbic acid, pyridoxine 5-phosphate, L-Arginine hydrochloride, Pregnenolone acetate. These components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. The composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The composition is fractionally extracted from herbs. Flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, L-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to Hcc and prevent Hcc recurrence.
The pharmaceutical ingredients involved in the composition are calculated to increase their effectiveness in preventing and curing cirrhosis and Hcc.
Currently, many preparations have been and are being studied to fight against cirrhosis and liver cancer globally. The effectiveness of this preparation is a new finding which has been proven over 5 years of follow-up.
Pregnenolone is a cortisol precursor. Cortisol plays an important role in several systems in the body, including the immune system(in the cycle of the immune system to produce B lymphocytes). This ingredient is used as a supplement to stabilize the endothelium, regulate the amount of cortisol within normal limits, and help the body produce B lymphocytes with a good response.
Kaempferol is a flavonoid that participates in cell protection against toxic proteins which were produced during prolonged inflammation; blocking the action and removing denatured proteins that change the parenchyma of liver cells. The selected flavonoids repaired the fibrotic structure of liver parenchyma after chronic inflammation. Ascorbic acid, pyridoxine 5-phosphate, and L-arginine help to facilitate biological functions in cell adhesion, synergize with flavonoids in cell membrane protection, structural repair, and liver cell regeneration.
Ascorbic acid, pyridoxine 5-phosphate act as enzymes that catalyze processes conveniently.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Udvidet adgang
Kontakter og lokationer
Studiesteder
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Ho Chi Minh City, Vietnam, 700000
- Saigon Biopharma Company Limited
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All patients with underlying medical conditions who have been taking medications for these conditions.
- Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
- The cancer patients are stable.
- Patients with congenital or acquired immunodeficiency.
Exclusion Criteria:
- Unstable cancer patients.
- Decompensated cirrhosis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Cirrhosis
Experimental benefits in resistance to cirrhosis were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(1) for various therapeutic purposes. |
The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.
Andre navne:
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Eksperimentel: Cirrhosis/Hcc "stable"
Experimental benefits in resistance to cirrhosis/Hcc were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(2) for various therapeutic purposes. |
The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Liver Stiffness Measurement (LSM)
Tidsramme: 36 months
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Liver stiffness is assessed by transient elastography to evaluate the degree of cirrhosis. Higher values indicate greater tissue stiffness. This measure reports the absolute liver stiffness values at the 36-month time point. |
36 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Liver Stiffness Measurement (LSM) for HCC Group
Tidsramme: 36 months
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Liver stiffness is assessed by transient elastography to evaluate tissue changes. This secondary outcome specifically analyzes the subgroup of participants who presented with hepatocellular carcinoma (HCC) within the study arms. |
36 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tran Minh Cam Tu, Dr., Saigon Biopharma Company Limited
Publikationer og nyttige links
Hjælpsomme links
- <p>Flavonoids as Multi-target Inhibitors for Proteins Associated with Ebola Virus: In Silico Discovery Using Virtual Screening and Molecular Docking Studies</p>
- <p>Vitamin C Is an Essential Factor on the Anti-viral Immune Responses through the Production of Interferon-α/β at the Initial Stage of Influenza A Virus (H3N2) Infection</p>
- <p>The antiviral properties of vitamin C</p>
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Neoplasmer i leveren
- Karcinom
- Patologiske tilstande, tegn og symptomer
- Carcinom, hepatocellulært
- Fibrose
Andre undersøgelses-id-numre
- Cirrhosis and Hcc
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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