Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Supplementation of Galatonol 300 mg Striatin 30 mg in Postpartum Lactating Mothers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Supplementation of Galatonol 300 mg Striatin 30 mg Combined Bioactive Fraction in Postpartum Lactating Mothers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind and placebo-controlled study involving mothers and their babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants katuk torbangun leaves and snakehead fish in stimulating breast milk production
Detailed Description:
The study product is a herbal product containing 300 mg Galatonol bioactive fraction enriched with 30 mg Striatin bioactive fraction This lactation supplement has been granted the marketing authorization from Badan Pengawas Obat dan Makanan Republik Indonesia BPOM RI as traditional medicine with the indication to enhance breast milk production
A total of 160 mothers 80 subjects in each group who have just delivered their babies are planned to participate in this study Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products study product or placebo and to come for follow-up visits at Day 4 8 and 15 End of Study
A total of 160 mothers 80 subjects in each group who have just delivered their babies are planned to participate in this study Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products study product or placebo and to come for follow-up visits at Day 4 8 and 15 End of Study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None