Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care

Not Applicable

Completed

• Conditions: Hair Loss
• Interventions: Dietary Supplement: Placebo sachet; Dietary Supplement: Banana flower extract sachet

• Registration Number: NCT05182801
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess Banana flower extract supplement on hair and body health care

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-10
• Primary Completion: 2022-01-21
• Study Completion: 2022-04-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy adults aged above 20 years old

Exclusion Criteria

• Subject who is not willing to participate in this study.
• Patients with diseases of the skin, liver, kidney.
• Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
• Female who is pregnant or nursing or planning to become pregnant during the course of the study.
• The students taught by the PI.
• Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo sachet	Placebo sachet	-
Banana flower extract sachet	Banana flower extract sachet	-

Primary Outcome Measures

Name	Time	Method
The change of hair loss amount	Change from Baseline hair loss amount at 12 weeks	Collected and measured the weight of loss hair
The change of hair density	Change from Baseline hair density at 12 weeks	Take a picture and observe the hair density
The change of hair follicle strength	Change from Baseline hair follicle strength at 12 weeks	Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area

Secondary Outcome Measures

Name	Time	Method
The change of scalp gloss	Change from Baseline scalp gloss at 12 weeks	Chroma Meter MM500 was utilized to measure scalp gloss
The change of SRD5A1 gene expression of blood	Change from Baseline SRD5A1 gene expression at 12 weeks	Venous blood was sampled to measure SRD5A1 gene expression
The change of hair diameter	Change from Baseline hair diameter at 12 weeks	Mitutoyo C/N293-100 was utilized to measure hair diameter
The change of TGF-β gene expression of blood	Change from Baseline TGF-β gene expression at 12 weeks	Venous blood was sampled to measure TGF-β gene expression
The change of dihydrotestosterone of blood	Change from Baseline hair diameter at 12 weeks	Venous blood was sampled to measure dihydrotestosterone
The change of AR gene expression of blood	Change from Baseline AR gene expression at 12 weeks	Venous blood was sampled to measure AR gene expression
The change of scalp redness	Change from Baseline scalp redness at 12 weeks	Chroma Meter MM500 was utilized to measure scalp redness
The change of scalp health	Change from Baseline scalp health at 12 weeks	Soft Plus was utilized to measure hair diameter
The change of testosterone of blood	Change from Baseline testosterone at 12 weeks	Venous blood was sampled to measure testosterone
The change of IGF-1 gene expression of blood	Change from Baseline IGF-1 gene expression at 12 weeks	Venous blood was sampled to measure IGF-1 gene expression

Trial Locations

Locations (1)

Chia Nan University of Pharmacy ＆ Science; 🇨🇳 Tainan, Taiwan