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Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers

NCT07111312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-12-11

No results posted yet for this study

Summary

Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.

Conditions

  • Telogen Effluvium

Interventions

DIETARY_SUPPLEMENT

Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.

Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.

OTHER

Placebo control

Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.

Sponsors & Collaborators

  • Olistic Research Labs S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-05-10
Completion
2025-09-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111312 on ClinicalTrials.gov