Acne VulgarisNCT04949932
Application of Poly-herbal Powder for Treating Acne Vulgaris
A study testing Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum. and Cicer arietinum powder in people with Acne Vulgaris, run by Dr. Md. Shahab Uddin at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum. and Cicer arietinum powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBangladesh
- Study dates
- 3 Apr 2021to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Poly-herbal Powder for Treating Acne Vulgaris: A Randomized, Double-Blind, Placebo-controlled Trial
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.
Read more
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.
Read the detailed 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.
- Conditions
- Acne Vulgaris
- Being tested
- Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum., Cicer arietinum powder
- Keywords
- Poly-herbal, Acne vulgaris, Powder, RCT, Bangladesh
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Cicer arietinum powderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Poly herbal powder (PHP) Receives: Other: Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum. |
| Placebo Arm | Placebo comparator | Powder of Cicer arietinum Receives: Other: Cicer arietinum powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 03 weeks
Secondary outcomes (2)
Change in The Global Acne Grading System score
The total severity score is derived from summation of six regional (i.e forehead, check, nose, chin, chest and back) sub scores. The summation of local score indicates, "0 = None, 1-18 = Mild, 19-30 = Moderate, 31-38 = Severe, > 39 = Very severe."
Measured: 03 weeks
Change in non-inflammatory and inflammatory lesions count
Pre and post treatment changes in non-inflammatory ( i.e Comedones) and inflammatory (i.e papule, pustule \& nodule) acne lesions count will be presented as percentage as well as mean and standard deviation.
Measured: 03 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start3 Apr 2021
- Primary completion15 Apr 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Md. Shahab Uddin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Md. Shahab Uddin, Hamdard University
- Investigators
- Dr.Md. S Uddin, BUMS, Principal investigator, MPH student, Hamdard University Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949932
- Sponsor's protocol ID
- HUBREC/2021/09/02
- Status last verified
- Jul 2021
- First submitted
- 20 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Poly-herbal Powder for Treating Acne Vulgaris: A Randomized, Double-Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04949932
- Acronym / sponsor ID
- HUBREC/2021/09/02
- Conditions
- Acne Vulgaris
- Keywords
- Poly-herbal, Acne vulgaris, Powder, RCT, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dr. Md. Shahab UddinUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum.Poly herbal powder (PHP) |
| Placebo Arm | Placebo comparator | Other: Cicer arietinum powderPowder of Cicer arietinum |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum.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. | Other | Intervention Arm |
| Cicer arietinum powderStudy 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. | Other | Placebo Arm |
Primary outcome
Change in Total Lesions Count (TLC)
Time frame: 03 weeks
Total Lesions Count (TLC) = Comedones + Papules + Pastules, before and after intervention will be presented as percentage as well as mean and standard deviation.
2 secondary outcomes
Change in The Global Acne Grading System score
Time frame: 03 weeks
Change in non-inflammatory and inflammatory lesions count
Time frame: 03 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: Yes. All Individual Participant Data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Md. S Uddin, BUMS principal investigator
MPH student, Hamdard University Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum. and Cicer arietinum powder in people with Acne Vulgaris, run by Dr. Md. Shahab Uddin at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Lesions Count (TLC) (time frame: 03 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.