Health Condition 1: - Health Condition 2: L239- Allergic contact dermatitis, unspecified cause
Conditions
Interventions
Intervention1: Barphani ointment: 5 gm topical application once a day for 4 weeks
Control Intervention1: Not applicable: Not applicable
Sponsors
Ayurved Sanshodhan Vibhag
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in EASI ScoreTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of Quality of life on Dermatology Life Quality Index (DLQI) 2.Assessment of change in Overall Disease Severity (ODS) Score i.e. treatment success. 3.Assessment of Changes in Pruritus Score on the Visual Analogue Scale (VAS) 4.Assessment of relapse of Eczema after 30 days of cessation of treatment 5.Assessment of Adverse Drug Reaction Global Assessment for overall change at the end of study. 6.Global assessment of overall safety of BARPHANI Ointment Timepoint: 30 Days | — |
Countries
India
Contacts
Public ContactAbhay N kulkarni
Ayurved seva sangh,Ayurved mahavidyalaya,nashik
Outcome results
None listed