- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05178303
Composition pour le traitement de la cirrhose et du cancer du foie (SB-1121) (SB-1121)
Composition pour le traitement de la cirrhose et du cancer du foie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Accès étendu
Contacts et emplacements
Lieux d'étude
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-
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Ho Chi Minh City, Viêt Nam, 700000
- Saigon Biopharma Company Limited
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
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Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Liver Stiffness Measurement (LSM)
Délai: 36 months
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Liver Stiffness Measurement (LSM) for HCC Group
Délai: 36 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tran Minh Cam Tu, Dr., Saigon Biopharma Company Limited
Publications et liens utiles
Liens utiles
- <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>
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs du foie
- Carcinome
- Conditions pathologiques, signes et symptômes
- Carcinome hépatocellulaire
- Fibrose
Autres numéros d'identification d'étude
- Cirrhosis and Hcc
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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