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

NCT01321645 — Phase 1, Completed, 31 participants, Miglani, Anjali

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

Registry	NCT01321645
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	31 (Actual)
Sponsor	Miglani, Anjali (Indiv); collaborators: Department of Indian Systems of Medicine and Homeopathy
Conditions	Acne Vulgaris
Interventions	Azadirachta Indica (Drug)
Dates	start 2011-03-01, primary completion 2012-05-01, completion 2012-06-01, first posted 2011-03-23, last updated 2012-10-23
Locations	1 site in India

-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

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+Arms and interventions

Azadirachta Indica (Drug): 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.

+Outcome measures

Primary outcomes

percent change in acne lesion counts from the Baseline [6 months]

Secondary outcomes

change in quality of life of subjects from baseline [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.

+Eligibility

Sex: All, ages: 12 Years to 25 Years

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

+Locations (1)

Facility	City	Country	Status
Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka	New Delhi, National Capital Territory of Delhi	India

+Investigators

Anjali Miglani, BHMS, Principal investigator, Department of Indian Systems of Medicine and Homeopathy