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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 20, 2011
First Posted Date  ICMJE March 23, 2011
Last Update Posted Date October 23, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
percent change in acne lesion counts from the Baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01321645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Official Title  ICMJE Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2012)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2011)
30
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321645
Other Study ID Numbers  ICMJE Acne-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Anjali Miglani, Miglani, Anjali
Study Sponsor  ICMJE Miglani, Anjali
Collaborators  ICMJE Department of Indian Systems of Medicine and Homeopathy
Investigators  ICMJE
Principal Investigator: Anjali Miglani, BHMS Department of Indian Systems of Medicine and Homeopathy
PRS Account Miglani, Anjali
Verification Date October 2012

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