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Effect of Justicia procumbens extract supplementation on women with mild to moderate hair damage: A randomized, double-blind, placebo-controlled trial

A 24-week randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of M-221222584 on improving hair shine, hair tensile strength, and hair thickness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009736
Enrollment
64
Registered
2024-08-30
Start date
2023-02-27
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The test group, which consumed tablets containing 500 mg of Justicia procumbens extract (active ingredient), and the placebo group, which consumed tablets without the active ingre

Sponsors

Ellead
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy adults aged 18 to 60 without alopecia and exhibiting mild to moderate hair damage, who: Will not use special hair care products or manipulate their hair during the study period. Agree to maintain a consistent hairstyle throughout the study. Understand and voluntarily consent to participate after comprehending the purpose and details of the study. Understand potential adverse reactions and have signed the informed consent form. Are free from acute or chronic significant skin disorders (as determined by the principal investigator, including severe atopic dermatitis or other eczematous skin conditions, severe infectious skin diseases). Can be observed during the trial period. Can adhere to visit schedules and follow research instructions during the trial period. Can restrict the use of similar dietary supplements, cosmetics, or medications during the trial period.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study include individuals who: Have AST or ALT or serum bilirubin > 2 times the upper normal limit (UNL) at screening, or have drug-induced/alcoholic hepatitis, liver cirrhosis, or require treatment for fatty liver disease. Have serum creatinine > 2 times UNL at screening, or have chronic kidney disease requiring dialysis. Have abnormal findings in blood or urine tests as determined by a specialist. Have had significant acute kidney, heart, liver, or other chronic diseases (e.g., diabetes with HbA1c = 9%, hypertension with systolic = 180 mmHg or diastolic = 110 mmHg, hypotension with systolic = 90 mmHg), or chronic debilitating diseases (e.g., hyperthyroidism or hypothyroidism, asthma) in the past six months that could affect the study results. Have a history of malignancy within the past five years. Have psychiatric disorders. Have infectious skin diseases. Have other forms of hair loss such as androgenic alopecia, alopecia areata, telogen effluvium, scarring alopecia, etc. Are pregnant, breastfeeding, or planning to become pregnant. Have taken oral dutasteride or finasteride within the past six months. Have applied local hair loss treatments, such as minoxidil, within the past month. Have taken medications such as steroids, cytotoxic agents, vasodilators, antihypertensives, anticonvulsants, beta-blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole, etc., within the past month. Have applied local steroid preparations to the scalp within the past month. Have taken medications affecting hair growth within the past three months or currently. Consume more than 40g/day of alcohol for men or 20g/day for women (40g of alcohol equals approximately 0.8 bottles of 17% soju or 1 liter of 5% beer). Have allergies/side effects to the test active ingredient [Justicia procumbens (L.) extract]. Have psoriasis (immunosuppressive drug use), severe atopic dermatitis (itchy symptoms, systemic symptoms, steroid use), or other severe skin conditions. Have experienced allergies to cosmetics or have sensitive or hypersensitive skin. Are in a state of insufficient energy and nutrients necessary for life support and mental or physical activities. Have used oral and topical retinoid/steroid agents or received dermatological treatments that could affect the study within the past six months before the study start. Are taking obesity treatments (absorption inhibitors and antidepressants, appetite suppressants), oral contraceptives, or female hormone preparations. Have participated in other human application trials and clinical trials within the past three months. Are deemed unsuitable for the study at the discretion of the principal investigator.

Design outcomes

Primary

MeasureTime frame
Hair gloss;Hair elasticity;Hair thickness

Secondary

MeasureTime frame
Hair improvement satisfaction assessment by subjects

Countries

Korea, Republic of

Contacts

Public ContactSun Hwa Lee

Ellead

emma0414@ellead.co.kr+82-31-709-9070

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026