MedDataX Logo

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

NCT ID: NCT04937374

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-05

Study Completion Date

2021-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: Rehmannia Glutinosa leaf extract

Arm 2: Placebo
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rehmannia glutinosa leaf extract

One capsule to be taken after breakfast for 56 days

Group Type ACTIVE_COMPARATOR

Rehmannia glutinosa leaf extract

Intervention Type OTHER

One capsule to be taken after breakfast.

Microcrystalline Cellulose (MCC)

One capsule to be taken after breakfast for 56 days

Group Type PLACEBO_COMPARATOR

Microcrystalline Cellulose (MCC)

Intervention Type OTHER

One capsule to be taken after breakfast.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rehmannia glutinosa leaf extract

One capsule to be taken after breakfast.

Intervention Type OTHER

Microcrystalline Cellulose (MCC)

One capsule to be taken after breakfast.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Females aged 18 to 35 years
2. Body Mass Index (BMI) in the range of ≥ 18.5 to ≤ 29.9 kg/m2.
3. Moderate to severe acne as per GAGS (defined with a score of 19 to 38)
4. Participants ready to continue usual skin care regime till the entirety of study duration.
5. Participant willing to abstain Anti-acne preparations (creams, face wash, home remedies, etc) throughout the study.
6. Participants must be ready to abstain from any food supplements or medications and other related products apart from the ones allowed during the study period.
7. Participants must be willing to complete all study designated questionnaires and diaries or any other related procedures or requirements.
8. Participants having the ability to understand and sign a written informed consent form.

Exclusion Criteria

1. Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
2. Consumption of any over-the-counter or prescribed oral anti-acne medications during the last 3 months prior to screening
3. Currently applying any over-the-counter or prescribed anti-acne medication including, but not limited to, retinoic acid or benzoyl peroxide over the past 3 months prior to screening.
4. Participants who have used facial, topical or injectable steroids 6 weeks prior to screening and during the study.
5. Females suffering from Polycystic Ovary Syndrome (PCOS).
6. Participant using oil and oil-based preparations for skin.
7. Consumptions of any herbal preparation, supplements, nutritional therapy or any other medications that is expected to improve acne over the past two weeks from randomization.
8. History of Hormonal imbalance
9. Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.35 or \> 4.94 µIU/mL.
10. Participant with high caffeine consumption, (defined as \>3 cups of coffee consumption in a day).
11. Topical or systemic use of antifungals and antibiotics in the previous 2 weeks prior to screening.
12. Participant having extremely oily food habits.
13. Participants taking drugs known to be photosensitizers including, but not limited to, phenothiazines, amiodarone, quinine, thiazides, tetracyclines, sulphonamides, quinolones
14. Known sensitivity to the investigational product or any excipients of the drug product.
15. Smoking or using any tobacco products.
16. Having a history of chronic skin allergies.
17. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
18. Participation in other clinical trials in last 30 days prior to screening
19. Participants with substance abuse problems (within 2 years) defined as:

* Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
* High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women.
20. Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
21. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
22. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Manjiri Jagtap, M.B.B.S, D.N.B

Role: PRINCIPAL_INVESTIGATOR

SKIN CURE N CARE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Skin cure and care clinic

Thāne, Maharashtra, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NS/201101/REHGLU/AV

Identifier Type: -

Identifier Source: org_study_id