NCT04937374

Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris

Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris: a Double Blinded, Randomized, Placebo-controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days.

Detailed description

In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study. The participants will consume one capsule per day containing active ingredient for the duration of 56 days. Throughout the duration of the clinical trial, The Investigator will be studying the formulation's effects on the change in the Global Acne Grading System (GAGS) score, facial sebum secretion, the number and irritability of inflammatory lesions, quality of life via the Acne-QoL questionnaire, skin wrinkle severity through the Modified Fitzpatrick Wrinkle Severity Scale (MFWS) and the percentage population of responders at the end of the study. The Investigator will also assess the change in skin radiance, luminosity, smoothness, texture, firmness, and skin hydration through a participant based self-assessment questionnaire as well as the safety and tolerability of the formulation through a global evaluation by the participants and the investigators.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
OTHER	Rehmannia glutinosa leaf extract	One capsule to be taken after breakfast.
OTHER	Microcrystalline Cellulose (MCC)	One capsule to be taken after breakfast.

Timeline

• Start date: 2021-06-05
• Primary completion: 2021-08-09
• Completion: 2021-10-04
• First posted: 2021-06-24
• Last updated: 2021-10-19

Locations

1 site across 1 country: India