Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Lappa Arctium
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Homoeopathy, Lappa Arctium
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
Outcomes
Primary Outcome Measures
percent change in acne lesion counts from the Baseline
Secondary Outcome Measures
change in quality of life of subjects
Full Information
NCT ID
NCT01040390
First Posted
December 26, 2009
Last Updated
February 15, 2012
Sponsor
Miglani, Anjali
Collaborators
Department of Indian Systems of Medicine and Homeopathy
1. Study Identification
Unique Protocol Identification Number
NCT01040390
Brief Title
Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Official Title
Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Lappa Arctium
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miglani, Anjali
Collaborators
Department of Indian Systems of Medicine and Homeopathy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 prescriptions. As a part of this study,efficacy of Lappa Arctium will be studied in the treatment of Acne vulgaris
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Homoeopathy, Lappa Arctium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lappa Arctium
Other Intervention Name(s)
Lappa Major
Intervention Description
To start with subjects will be prescribed Lappa Arctium 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.
Primary Outcome Measure Information:
Title
percent change in acne lesion counts from the Baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in quality of life of subjects
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Miglani, BHMS
Organizational Affiliation
Department of Indian Systems of Medicine and Homeopathy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110075
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
24931753
Citation
Miglani A, Manchanda RK. Observational study of Arctium lappa in the treatment of acne vulgaris. Homeopathy. 2014 Jul;103(3):203-7. doi: 10.1016/j.homp.2013.12.002.
Results Reference
derived
Learn more about this trial
Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris
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