NCT01321632

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

March 20, 2011

Last Update Submit

October 21, 2012

Conditions

Keywords

Acne VulgarisHomoeopathyZingiber officinalis

Outcome Measures

Primary Outcomes (1)

  • percent change in acne lesion counts from the Baseline

    6 months

Secondary Outcomes (1)

  • change in quality of life of subjects from baseline

    6 months

Interventions

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.

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka

New Delhi, National Capital Territory of Delhi, 110075, India

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Anjali Miglani, BHMS

    Department of Indian Systems of Medicine and Homeopathy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Medical Officer

Study Record Dates

First Submitted

March 20, 2011

First Posted

March 23, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations