Viewing Study NCT06552039



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06552039
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-30

Brief Title: Proof-of-Science Prospective Interventional Three-arm Double-Blind Randomized Safety and Efficacy Real World Evidence Study
Sponsor: None
Organization: None

Study Overview

Official Title: Scientific Evaluation of the Safety and Efficacy of Herbal and Non Herbal Formulations in Mitigating Hair Fall Promoting Hair Growth and Preventing Premature Hair Graying
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 proof-of-science prospective interventional three-arm double-blind randomized safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subjects having complaint of hair fall and pre-mature graying
Detailed Description: Considering the clinical safety efficacy study a sufficient number 99 subjects 33 subjectarm will be enrolled to 90 subjects 30 subjectarm completed the study In each arm fifteen 15 participants per group will be recruited with one group consisting of individuals experiencing mild to moderate Androgenetic Alopecia AGA class 1 2 3 while the other group will comprise fifteen 15 healthy subjects with symptoms of hair loss and premature graying The potential subjects will be screened as per the inclusion exclusion criteria only after obtaining written informed consent from the subjects The adult femalemale subjects will be instructed to visit the facility as per the below visits

Visit 01 Day -04 Screening Tattoo creation Hair Growth Rate measurement
Visit 02 Day 01 Enrolment Hair Growth Rate measurement All evaluations
Visit 03 Day 45 2 days Treatment Phase
Visit 04 Day 87 2 days Treatment Phase Tattoo creation Hair Growth Rate measurement Visit 05 Day 90 3 days from visit 04 Hair Growth Rate measurement All evaluations
Visit 06 Day 120 2 days End of Treatment Phase All evaluations

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