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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01321632
Other study ID # Acne-002
Secondary ID
Status Completed
Phase Phase 1
First received March 20, 2011
Last updated October 21, 2012
Start date March 2011
Est. completion date July 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 Zingiber officinalis will be studied in the treatment of Acne vulgaris


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date July 2012
Est. primary completion date June 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


Intervention

Drug:
Zingiber officinalis
To start with subjects will be prescribed Zingiber officinalis 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
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