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Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris

This study has been completed.
Sponsor:
Collaborator:
Directorate of ISM & H
Information provided by (Responsible Party):
Dr. Anjali Miglani, Miglani, Anjali
ClinicalTrials.gov Identifier:
NCT01040390
First received: December 26, 2009
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
 Drug: Lappa Arctium
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Lappa Arctium

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Miglani, Anjali:

Primary Outcome Measures:
  • percent change in acne lesion counts from the Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in quality of life of subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lappa Arctium
    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.
    Other Name: Lappa Major
  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040390

Locations
India
Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
New Delhi, Delhi, India, 110075
Sponsors and Collaborators
Miglani, Anjali
Directorate of ISM & H
Investigators
Principal Investigator: Anjali Miglani, BHMS Directorate of ISM & H
  More Information

No publications provided

Responsible Party: Dr. Anjali Miglani, Senior Medical Officer, Miglani, Anjali
ClinicalTrials.gov Identifier: NCT01040390     History of Changes
Other Study ID Numbers: Acne-001
Study First Received: December 26, 2009
Last Updated: February 15, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Miglani, Anjali:
Acne Vulgaris
Homoeopathy
Lappa Arctium

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 16, 2013