Health Condition 1: L20-L30- Dermatitis and eczema
Conditions
Interventions
None listed
Sponsors
Ayurvedic and Unani Tibbia College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Individuals with Eczema confirmed according to symptoms of Vicharchika explained in the ayurvedic texts (Brihattrayi) as well as the American Academy of Dermatology Criteria. 2 Individuals of either gender aged 16 to 70 years40. 3 EASI score less than or equal to 50.
Exclusion criteria
Exclusion criteria: 1. Populations with skin diseases other than eczema and Scabies, Seborrheic dermatitis, Contact dermatitis (irritant or allergic), Ichthyoses, Cutaneous T-cell lymphoma, Psoriasis, Photosensitivity dermatoses, Immune deficiency diseases, Erythroderma of other causes mentioned in exclusionary criteria of diagnostic criteria for Atopic Dermatitis in American Academy of Dermatology. 2. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week before the screening visit. 3. Patients with comorbid conditions such as known cases of Diabetes mellitus (Fasting blood sugar more than 126mg/dl), Grade 2 hypertension (BP more than 160/100mmhg), Renal impairment (Sr. creatinine more than 1.2 mg/dl), Hepatic impairment (SGOT and SGPT more than three times the upper limit). 4. Subjects with a history of any cardiovascular disease such as coronary artery disease, congestive heart failure, valvular heart disease, etc. 5. Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc. 6. Pregnant women and lactating mothers. 7. Participants who had received topical corticosteroids, systemic steroids, immunosuppressants, and immunomodulators one month before screening. 8. Participants with a history of allergic reactions to ayurvedic drugs and those who exhibit sensitivity in the patch test to the topical medication. 9. Currently participating or participated in any other study of a drug, within the past 6 months before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving more than or equal to 50% improvement in EASI (Eczema Area and Severity Index) OR more than or equal to 6.6 point reduction in EASI scoreTimepoint: Day 1, Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in severity of dermatitis symptoms measured by vIGA-AD11(Validated Investigator Global Assessment scale for Atopic Dermatitis) and Itch NRS. 2. Change in serum IgE levels and AEC as a marker of allergic inflammation. 3. Proportion of participants achieving more than or equal to 4 point reduction in DLQI (Dermatology Life Quality Index). 4. Digital Photo documentation of the affected skin areas will be taken at baseline and after the treatment to visually document changes in the condition.Timepoint: Day 1, Day 91 | — |
Countries
India
Contacts
Public ContactDr Sujata Yadav
Ayurvedic and Unani Tibbia College and Hospital
Outcome results
None listed