Clinical trial of Ayurvedic capsule and cream in pimples
- Conditions
- Health Condition 1: null- Acne Vulgaris
- Registration Number
- CTRI/2016/06/007032
- Lead Sponsor
- Ari Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in total numbers of inflammatory acne lesions on faceTimepoint: Day 0, Day 15, Day 30, Day 45, Day 60
- Secondary Outcome Measures
Name Time Method 1.Changes in total numbers of non-inflammatory acne lesions on face <br/ ><br>2.Changes in total lesion count on face <br/ ><br>3.Changes in Acne vulgaris indices and severity <br/ ><br>4.Changes in sign and symptoms of acne vulgaris <br/ ><br>5.Global assessment of overall improvement by patient and by physician <br/ ><br>6.Changes in acne scarring <br/ ><br>7.Assessment of skin lightening effect <br/ ><br>8.Changes in post acne dark spots <br/ ><br>9. Tolerability of trial drugs by patient and by physician. <br/ ><br>10.Changes in laboratory investigations.Timepoint: Day 0, Day 15, Day 30, Day 45, Day 60