Application of Poly-herbal Powder for Treating Acne Vulgaris

NCT04949932 | Completed DMC

• 1 other identifier: HUBREC/2021/09/02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Acne is a common problem in adolescence to young adult. But there is no such remedy available for acne treatment which has no side effects. Different types of herbs powder has been using in patients with acne vulgaris in the traditional practice of Indian subcontinent as single form or compound. Scientific evidence have shown many herbs has no known side effects and effective on acne. These herbs have antibacterial, anti-inflammatory and anti-oxidant effects. So, This study is intended to find out an inexpensive and safe alternative by using some common herbs such as Azadirachta indica, Curcuma longa, Lens culinaris Mentha arvensis and Trigonella foenum-graecum. The aim of the study is to evaluate the clinical efficacy of Poly herbal powder (PHP) for treating patients with acne vulgaris. Total of 42 adults with acne vulgaris was recruited for this study. Study subjects was included both of male and female with age limit of 18 to 35 years. Duration of study is 05 months with "day one advertisement" for screening followed by randomization for the treatment. The duration of active participation of each study subject was 3 consecutive weeks or 21days. Difference of baseline and post intervention mean by Total lesion Count (TLC) compared with placebo and assesses the % of reduction of acne based on The Global Acne Grading System (GAGS) score. Safety assessment was obtained from the incidence and type of adverse events during study period.

Conditions

Acne Vulgaris

Keywords

Poly-herbal; Acne vulgaris; Powder; RCT; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Change in Total Lesions Count (TLC)

  Total Lesions Count (TLC) = Comedones + Papules + Pastules, before and after intervention will be presented as percentage as well as mean and standard deviation.

  03 weeks

Secondary Outcomes (2)

• Change in The Global Acne Grading System score

  03 weeks

• Change in non-inflammatory and inflammatory lesions count

  03 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Poly herbal powder (PHP)

Other: Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum.

Placebo Arm

PLACEBO COMPARATOR

Powder of Cicer arietinum

Other: Cicer arietinum powder

Interventions

Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum. OTHER

Study subjects were prescribed either PHP or placebo once daily at night for 3 weeks consecutively. A dose of 1-2 tea spoonfuls powder had to mixed with water to make paste. Then it was applied on face (except around the eyes) and had to wait for 20-30 minutes until it dries.Then they were washed face by using normal water.

Intervention Arm

Cicer arietinum powder OTHER

Study subjects were prescribed either PHP or placebo once daily at night for 3 weeks consecutively. A dose of 1-2 tea spoonfuls powder had to mixed with water to make paste. Then it was applied on face (except around the eyes) and had to wait for 20-30 minutes until it dries.Then they were washed face by using normal water.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women both aged between 18-35 years
• Presenting minimum 5 acne lesions (whiteheads, blackheads, papules, pustules, nodules)
• Study subject who will be agreed with Online informed consent.

You may not qualify if:

• Have infected acne lesions
• If study subject suffers from any serious medical conditions such as uncontrolled hypertension, diabetes mellitus, past or current malignancy, liver or kidney dysfunction, active pulmonary tuberculosis other severe dermatitis, or any infectious or systemic diseases.
• Use of a topical medication containing steroids for the treatment of skin disease more than once per month.
• Hypersensitive skin.
• Erythema, or telangiectasia at the test site.
• Use of the same or similar cosmetics (or pharmaceutical) on the test site within three months of screening.
• Having undergone a skin peeling or having wrinkles removed within six months.
• Any other reasons of unsuitability for the clinical trial at the discretion of the study.

Sponsors & Collaborators

• Dr. Md. Shahab Uddin: lead

Study Sites (1)

Hamdard University Bangladesh

Munshiganj, 1510, Bangladesh

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

turmeric extract; fenugreek seed meal

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Dr.Md. S Uddin, BUMS

  MPH student, Hamdard University Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 2, 2021
• Study Start: April 3, 2021
• Primary Completion: April 15, 2021
• Study Completion: May 12, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting 6 months after publication.
• Access Criteria: Request by email.

Locations

BA (1)