Health Condition 1: L853- Xerosis cutis
Conditions
Interventions
Intervention1: Amarantha Foot Care Cream
: It contains Madhuka Taila (Madhuca indica), Sarjaras Exudate (Shorea robusta), Jatyadi Taila (Ayurvedic Classical Formulation), Tankan Bhasma, Pudina Satva (
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects suffering from moderate to severe xerosis of foot (XAS score > 3 and 2.Subjects who had not used any moisturizers or keratolytic agents since last week. 3.Subjects willing to make all required study visits
Exclusion criteria
Exclusion criteria: 1.Subjects having foot lesions (ulcer, skin infection) 2.Subjects with very severe hyperkeratosis requiring chiropody treatment 3.Subjects with skin disorders affecting the foot such as infections (e.g. Athleteââ?¬•s foot), dermatitis, psoriasis, un-healed skin wounds (including open heel fissures), ulcers or blisters 4.Subjects with systematic disease including peripheral vascular disease or musculoskeletal disorders of the foot or ankle, rheumatoid arthritis or diabetes 5.Subjects having unstable angina pectoris, myocardial infarction, stroke, chronic renal and liver diseases, uncontrolled diabetes mellitus and uncontrolled hypertension. 6.Known cases of HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases 7.Known hypersensitivity to ingredients used in study drug 8.Pregnant and lactating women 9.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days required for complete healing / complete clearance of Index cracked HeelTimepoint: Day 0, Day 7, Day 14, Day 21, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Xerosis assessment scale 2. Changes in skin roughness using graded scale 3. Changes in hyperkeratosis using graded scale 4. Changes in Overall Clinical Cutaneous Score (OCCS) 5. Clinical photographs of heels 6. Drug compliance at every follow up visits 7. Global assessment of overall change by investigator and subject 8. Changes in tolerability of trial drugs by patient and by physician 9. Adverse Events/Adverse Drug Reactions Timepoint: Day 0, Day 7, Day 14, Day 21, Day 28 | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed