Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
Vaginitis
Interventions
DRUG

0.9% NaCl physiological saline

Vaginal-spraying 0.9% NaCl physiological saline is prepared by extracting 10 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque metallic spraying 20 mL-bottle.

COMBINATION_PRODUCT

LiveSpo X-secret

"In Vietnam, LiveSpo X-SECRET is manufactured as two product lines: (1) Class-A medical device product (Product declaration No.220003286/PCBA-HN) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam and ISO 13485:2016 (Certificate No YT117-19) and (2) comestic (Product declaration No.14981/22/CBMP-HA) under manufacturing standards approved by Hanoi Department of Health, Ministry of Health, Vietnam (Certificate No 118/CNĐĐKSXMP. Both product lines have the same probiotic composition.~The cosmetic type was used for the clinical trial conducted at Hanoi OGH. The Class-A medical device type was used for the clinical trial conducted at Bac Ninh CDC."

Trial Locations (2)

100000

Hanoi Obstetrics and Gynecology Hospital, Ba Dinh

220000

Centers for Disease Control and Prevention, Bắc Ninh

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hanoi Obstetrics and Gynecology Hospital

OTHER

collaborator

Centers for Disease Control and Prevention

FED

lead

Anabio R&D

INDUSTRY

NCT06165354 - Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis | Biotech Hunter | Biotech Hunter