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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Azadirachta Indica

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Homoeopathy, Homeopathy, Azadirachta Indica

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

percent change in acne lesion counts from the Baseline

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01321645

First Posted

March 20, 2011

Last Updated

October 21, 2012

Sponsor

Miglani, Anjali

Collaborators

Department of Indian Systems of Medicine and Homeopathy

1. Study Identification

Unique Protocol Identification Number

NCT01321645

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Miglani, Anjali

Collaborators

Department of Indian Systems of Medicine and Homeopathy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 Azadirachta Indica will be studied in the treatment of Acne vulgaris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne Vulgaris, Homoeopathy, Homeopathy, Azadirachta Indica

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Azadirachta Indica

Intervention Description

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.

Primary Outcome Measure Information:

Title

percent change in acne lesion counts from the Baseline

Time Frame

6 months

Secondary Outcome Measure Information:

Title

change in quality of life of subjects from baseline

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anjali Miglani, BHMS

Organizational Affiliation

Department of Indian Systems of Medicine and Homeopathy

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110075

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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