Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04949932 |
| Other study ID # |
HUBREC/2021/09/02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 3, 2021 |
| Est. completion date |
May 12, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Hamdard University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background:
Due to increasing interest from acne patients concerned about the side effects associated
with conventional therapies, complementary and alternative medicine (CAM) has been suggested
as a new therapeutic modality for acne vulgaris. Herbal medicine is one of these CAM
treatments. 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. As for example,
Azadirachta indica, Curcuma longa, Ocimum sanctum, Lens culinaris, Trigonella foenum-graecum
and Mentha arvensis etc. These herbs have antibacterial, anti-inflammatory and anti-oxidant
effects. Therefore, this study was designed to evaluate the efficacy of poly-herbal powder
(PHP) for treating acne vulgaris using some of these plants.
Objective:
To evaluate the clinical efficacy of PHP compared with that of placebo (PBO) in patients with
acne vulgaris.
Sample Size:
Literature review have shown that sample size were included 20, 40, 75 and 503 study subjects
in various research for treating acne vulgaris. Prior study has shown that the mean±SD of
acne vulgaris at the baseline was 19.66 ±3.93 and after intervention it was 14.33±5.96
according to GAGS. Based on this results, the estimated enrollment of 15 per treatment group
among those with acne vulgaris would provide the study with a statistical power of 80% (α =
0.05) and Confidence interval of 95% to detect the significant efficacy in acne. By using
OpenEpi online calculator, required sample size is 30. But possibility of loss to follow up
the inflated sample size is 42.
Methods:
For study subjects recruitment, advertisement was posted on online social networking
platforms (such as facebook, Facebook Messenger, facebook groups, linkedIn, what's up and
e-mail). The all relevant study requirements was included in the advertisement following a
link of Google Form Questionnaire (socio-demographic data, specially instructed photograph)
to participate in this study. Enrollment of respondent was done by acne lesions counting from
the photograph sent by the study subjects through Google Form following fulfillment of
inclusion criteria.
Thereafter, Study subject was assigned to either PHP or PBO randomly for 03 consecutive weeks
and intervention products was sent by courier according to study subject's present address.
After intervention period study subjects was had to fill another Google Form Questionnaire
including socio-demographic data, specially instructed photograph and other information.
(Instructions for Taking Photograph: Mobile phone with camera, camera resolution must be 8 or
more than 8 Mega pixels. Study subject has to take photo from a distance of 12 inches from
face. Upload total of 6 photos (Right sided 2 photos, Left sided 2 photos and 2 photos from
front) of face.)
An intention-to-treat analysis will be conducted for patients who have received intervention
at least once. Data will be presented as mean±SD and percentage of reduction in the change of
counting acne lesions with 95% confidence interval and p=0.05.
Efficacy Assessment:
Difference of baseline and post intervention mean by Total lesion Count (TLC) compared with
placebo and assesses the % of reduction of acne based on GAGS score. Difference between two
means will be compared with independent two sample t-test.
The Global Acne Grading System (GAGS):
The GAGS is a quantitative scoring system to assess acne severity. It was first developed by
Doshi and colleagues in 1997. The total severity score is derived from summation of six
regional sub scores. Each is derived by multiplying the factors-2 for forehead, 2 for each
check, 1 for nose, 1 for chin, 3 for both chest and back by the most heavily weighted lesion
within each region (1 for ≥ one comedone, 2 for ≥ one papule,3 for ≥ one pustule, and 4 for ≥
one nodule). The regional factors were derived from consideration of surface area and
distribution and density of pilosebaceous units. The summation of local score indicates, "0 =
None, 1-18 = Mild, 19-30 = Moderate, 31-38 = Severe, > 39 = Very severe."
Data and Safety Monitoring:
To maintain the quality of this trial, data & safety monitoring will be conducted by Data &
Safety Monitoring Board (DSMB). The members of the DSMB was included that individual who was
not involved directly in this research. For this clinical trial, DSMB members was joined from
the Faculty of Unani and Ayurvedic Medicine of Hamdard University Bangladesh (HUB).
Safety assessment was obtained from the incidence and type of adverse events during study
period.
