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Efficacy of Azadirachta Indica (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:
NCT01321645
First received: March 20, 2011
Last updated: October 21, 2012
Last verified: October 2012
History of Changes

March 20, 2011
October 21, 2012
March 2011
May 2012   (final data collection date for primary outcome measure)
percent change in acne lesion counts from the Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321645 on ClinicalTrials.gov Archive Site
change in quality of life of subjects from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris
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
Not Provided
Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acne Vulgaris
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01321645
Acne-003
Yes
Dr. Anjali Miglani, Miglani, Anjali
Miglani, Anjali
Directorate of ISM & H
Principal Investigator: Anjali Miglani, BHMS Directorate of ISM & H
Miglani, Anjali
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP