Effectivity of Barphani Ointment in patients suffering from Eczema.

Phase 2

Conditions: Health Condition 1: - Health Condition 2: L239- Allergic contact dermatitis, unspecified cause

Registration Number: CTRI/2019/08/020618

Lead Sponsor: Ayurved Sanshodhan Vibhag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male or Female Subjects in the age group of 18 to 60 years, both inclusive.

2.Subjects with confirmed patients of dermatitis with lesion size atleast 2cms.

3.Subjects with Eczema having area severity score of 1.

4.Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy tubal ligation or is > 2 years postmenopausal

5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form

Exclusion Criteria

1.Subjects who have received systemic treatment for eczema or any conventional systemic treatment for more than 4 weeks one month prior to screening in the study.

2.Any laser dermatological procedure, 4 weeks prior to screening in this study.

3.. Known case of any active malignancy.

4.Cases of chronic origin.

5.Lesions of large surface area.

6.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

7.Subjects participating currently or 1 month prior to recruitment in any other clinical study

8.Known hypersensitivity to any of the ingredients used in study drug.

9.Pregnant and Lactating females

10. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator judgment.

11.Subject has H/O keliod formation following skin injury, severe dermatitis requiring systemic corticosteroids.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in EASI ScoreTimepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Quality of life on Dermatology Life Quality Index (DLQI) <br/ ><br>2.Assessment of change in Overall Disease Severity (ODS) Score i.e. treatment success. <br/ ><br>3.Assessment of Changes in Pruritus Score on the Visual Analogue Scale (VAS) <br/ ><br>4.Assessment of relapse of Eczema after 30 days of cessation of treatment <br/ ><br>5.Assessment of Adverse Drug Reaction Global Assessment for overall change at the end of study. <br/ ><br>6.Global assessment of overall safety of BARPHANI Ointment <br/ ><br>Timepoint: 30 Days