Health Condition 1: null- Acne Vulgaris
Conditions
Interventions
Intervention1: AHPL/AYCAP/0413 capsule: It contains Sariva Extract (Hemidesmus indicus), Guduchi Extract (Tinospora cordifolia), Manjishtha Extract (Rubia cordifolia), Yashtimadhuka Extract (Glycyrrh
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from acne vulgaris (mild, moderate and severe) as diagnosed by physician or dermatologist 2. Subject willing to participate in clinical trial and who have read, understood and signed informed consent form. 3. Subjects willing to make all required study visits 4. Subjects willing to follow study instructions given by the investigator
Exclusion criteria
Exclusion criteria: 1.Patients with preexisting systemic disease necessitating long-term medications. 2.Patients with history of genetic and endocrinal disorders. 3.Patients having menstrual disorders and patients with drug induced acne. 4.Patients having systemic/topical treatment for acne vulgaris since last 3 months. 5.Patients who are using any kind of face application for the management of acne. 6.Patients suffering from major/severe illness(s). 7.Patients having or given history of HIV, Hepatitis B or C, diabetes mellitus, hepatic/renal diseases and/or any other major skin disease(s). 8.Pregnant and lactating women 9.Subject having known hypersensitivity to any ingredient of investigational drugs . 10.Subjects with significant abnormal laboratory parameters 11.ECG demonstrating any signs of uncontrolled arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in total numbers of inflammatory acne lesions on faceTimepoint: Day 0, Day 15, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in total numbers of non-inflammatory acne lesions on face 2.Changes in total lesion count on face 3.Changes in Acne vulgaris indices and severity 4.Changes in sign and symptoms of acne vulgaris 5.Global assessment of overall improvement by patient and by physician 6.Changes in acne scarring 7.Assessment of skin lightening effect 8.Changes in post acne dark spots 9. Tolerability of trial drugs by patient and by physician. 10.Changes in laboratory investigations.Timepoint: Day 0, Day 15, Day 30, Day 45, Day 60 | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed