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

This study has been completed.
Sponsor:
Collaborator:
Department of Indian Systems of Medicine and Homeopathy
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
  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 Azadirachta Indica will be studied in the treatment of Acne vulgaris


Condition Intervention Phase
Acne Vulgaris
Drug: Azadirachta Indica
Phase 1

Study Type: Interventional
Study Design: 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 - Azadirachta Indica

Resource links provided by NLM:


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 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.


Enrollment: 31
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Anjali Miglani, Senior Medical Officer, Miglani, Anjali
ClinicalTrials.gov Identifier: NCT01321645     History of Changes
Other Study ID Numbers: Acne-003
Study First Received: March 20, 2011
Last Updated: October 21, 2012
Health Authority: India: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014