Acne VulgarisPhase 1NCT01321645
Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris
A Phase 1 study testing Azadirachta Indica in people with Acne Vulgaris, run by Miglani, Anjali at 1 site in India.
Trial summary
Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Azadirachta Indica
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2011to Jun 2012
- Phase
- Phase 1
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females between 12 to 25 years of age
- Presence of inflammatory and non-inflammatory lesions
- Able to follow-up according to protocol
- Patients not taking any medication for treatment of Acne in preceding one month.
Who cannot join
- Acne Conglobata
- Pregnant or Breast feeding females or females having intention of becoming pregnant
- Significant systemic disease
- Any drug/ alcohol addiction
- History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome
Trial locations and contacts
1 site in 1 country.
India1 site
Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
New Delhi, National Capital Territory of Delhi, 110075
About this study
Official title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica
Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Azadirachta Indica
- Keywords
- Acne Vulgaris, Homoeopathy, Homeopathy, Azadirachta Indica
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azadirachta IndicaDrug
To start with subjects will be prescribed Azadirachta Indica in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change in acne lesion counts from the Baseline
Measured: 6 months
Secondary outcomes (1)
change in quality of life of subjects from baseline
Change in Quality of life will be assessed based on Quality of Life Questionnaire to be filled by subjects at the start of Treatment and at the end of time frame.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionJun 2012
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miglani, Anjali
- Collaborators
- Department of Indian Systems of Medicine and Homeopathy
- Responsible party
- Principal investigator, Dr. Anjali Miglani, Miglani, Anjali
- Investigators
- Anjali Miglani, BHMS, Principal investigator, Department of Indian Systems of Medicine and Homeopathy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321645
- Sponsor's protocol ID
- Acne-003
- Status last verified
- Oct 2012
- First submitted
- 20 Mar 2011
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica
- ClinicalTrials.gov ID
- NCT01321645
- Acronym / sponsor ID
- Acne-003
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Homoeopathy, Homeopathy, Azadirachta Indica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Miglani, Anjali
- Collaborators
- Department of Indian Systems of Medicine and Homeopathy
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Mar 2011 (estimated)
- 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 one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Azadirachta Indica will be studied in the treatment of Acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males and females between 12 to 25 years of age
- Presence of inflammatory and non-inflammatory lesions
- Able to follow-up according to protocol
- Patients not taking any medication for treatment of Acne in preceding one month.
Key exclusion criteria (5 listed)
- Acne Conglobata
- Pregnant or Breast feeding females or females having intention of becoming pregnant
- Significant systemic disease
- Any drug/ alcohol addiction
- History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome
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 |
|---|---|---|
| Azadirachta IndicaTo start with subjects will be prescribed Azadirachta Indica in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles. | Drug | – |
Primary outcome
percent change in acne lesion counts from the Baseline
Time frame: 6 months
1 secondary outcome
change in quality of life of subjects from baseline
Time frame: 6 months
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 23 Oct 2012.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Anjali Miglani, BHMS principal investigator
Department of Indian Systems of Medicine and Homeopathy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azadirachta Indica in people with Acne Vulgaris, run by Miglani, Anjali at 1 site in India.
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 4 inclusion and 5 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 23 Oct 2012. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percent change in acne lesion counts from the Baseline (time frame: 6 months). 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 23 Oct 2012.