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Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01321645
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : October 23, 2012
Sponsor:
Collaborator:
Department of Indian Systems of Medicine and Homeopathy
Information provided by (Responsible Party):
Dr. Anjali Miglani, Miglani, Anjali

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 Azadirachta Indica will be studied in the treatment of Acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Azadirachta Indica Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica
Study Start Date : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources


Intervention Details:
    Drug: Azadirachta Indica
    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.


Primary Outcome Measures :
  1. percent change in acne lesion counts from the Baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in quality of life of subjects from baseline [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321645


Locations
India
Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
New Delhi, Delhi, India, 110075
Sponsors and Collaborators
Miglani, Anjali
Department of Indian Systems of Medicine and Homeopathy
Investigators
Principal Investigator: Anjali Miglani, BHMS Department of Indian Systems of Medicine and Homeopathy

Responsible Party: Dr. Anjali Miglani, Senior Medical Officer, Miglani, Anjali
ClinicalTrials.gov Identifier: NCT01321645     History of Changes
Other Study ID Numbers: Acne-003
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Dr. Anjali Miglani, Miglani, Anjali:
Acne Vulgaris
Homoeopathy
Homeopathy
Azadirachta Indica

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