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

Acne Vulgaris Clinical Trial

Official title:

Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Azadirachta Indica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321645
• Other study ID #: Acne-003
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2011
• Last updated: October 21, 2012
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Miglani, Anjali
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
India	Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka	New Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Miglani, Anjali	Department of Indian Systems of Medicine and Homeopathy

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change in acne lesion counts from the Baseline		6 months	No
Secondary	change in quality of life of subjects from baseline	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.	6 months	No