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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040390
Other study ID # Acne-001
Secondary ID
Status Completed
Phase Phase 1
First received December 26, 2009
Last updated February 15, 2012
Start date March 2010
Est. completion date December 2011

Study information

Verified date February 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 Lappa Arctium will be studied in the treatment of Acne vulgaris


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2011
Est. primary completion date December 2011
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

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


Related Conditions & MeSH terms


Intervention

Drug:
Lappa Arctium
To start with subjects will be prescribed Lappa Arctium 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 6 months No
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