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

Primary Purpose

Hair Loss

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo sachet
Banana flower extract sachet
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hair Loss

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chia Nan University of Pharmacy ＆ Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo sachet

Banana flower extract sachet

Arm Description

Outcomes

Primary Outcome Measures

The change of hair loss amount
Collected and measured the weight of loss hair
The change of hair density
Take a picture and observe the hair density
The change of hair follicle strength
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

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

Full Information

First Posted
January 4, 2022
Last Updated
May 11, 2022
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05182801
Brief Title
Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care
Official Title
Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo sachet
Arm Type
Placebo Comparator
Arm Title
Banana flower extract sachet
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo sachet
Intervention Description
Blank
Intervention Type
Dietary Supplement
Intervention Name(s)
Banana flower extract sachet
Intervention Description
Happy Angel Banana Flower Extract sachet
Primary Outcome Measure Information:
Title
The change of hair loss amount
Description
Collected and measured the weight of loss hair
Time Frame
Change from Baseline hair loss amount at 12 weeks
Title
The change of hair density
Description
Take a picture and observe the hair density
Time Frame
Change from Baseline hair density at 12 weeks
Title
The change of hair follicle strength
Description
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
Time Frame
Change from Baseline hair follicle strength at 12 weeks
Secondary Outcome Measure Information:
Title
The change of scalp gloss
Description
Chroma Meter MM500 was utilized to measure scalp gloss
Time Frame
Change from Baseline scalp gloss at 12 weeks
Title
The change of scalp redness
Description
Chroma Meter MM500 was utilized to measure scalp redness
Time Frame
Change from Baseline scalp redness at 12 weeks
Title
The change of scalp health
Description
Soft Plus was utilized to measure hair diameter
Time Frame
Change from Baseline scalp health at 12 weeks
Title
The change of hair diameter
Description
Mitutoyo C/N293-100 was utilized to measure hair diameter
Time Frame
Change from Baseline hair diameter at 12 weeks
Title
The change of dihydrotestosterone of blood
Description
Venous blood was sampled to measure dihydrotestosterone
Time Frame
Change from Baseline hair diameter at 12 weeks
Title
The change of testosterone of blood
Description
Venous blood was sampled to measure testosterone
Time Frame
Change from Baseline testosterone at 12 weeks
Title
The change of SRD5A1 gene expression of blood
Description
Venous blood was sampled to measure SRD5A1 gene expression
Time Frame
Change from Baseline SRD5A1 gene expression at 12 weeks
Title
The change of AR gene expression of blood
Description
Venous blood was sampled to measure AR gene expression
Time Frame
Change from Baseline AR gene expression at 12 weeks
Title
The change of TGF-β gene expression of blood
Description
Venous blood was sampled to measure TGF-β gene expression
Time Frame
Change from Baseline TGF-β gene expression at 12 weeks
Title
The change of IGF-1 gene expression of blood
Description
Venous blood was sampled to measure IGF-1 gene expression
Time Frame
Change from Baseline IGF-1 gene expression at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chia Nan University of Pharmacy ＆ Science
City
Tainan
ZIP/Postal Code
71710
Country
Taiwan

12. IPD Sharing Statement

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

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