None listed
Conditions
Interventions
Intervention1: MUKUL PURE capsules: Two times a day before breakfast and dinner for 90 days taken orally
Control Intervention1: Placebo Capsules: Two times a day before breakfast and dinner for 90 day
Sponsors
VIdya Herbs
Eligibility
Inclusion criteria
Inclusion criteria: • Both Male / Female of age between 18-50 yrs • Facial acne, with: 1. Inflammatory facial lesions (papules/pustules/nodules/cysts) 2. Non inflammatory facial lesions if open (blackhead) and if closed (whitehead) comedones 3. Mild to moderate acne with nodular abcesses, extensive lesions • Willing to give written informed consent along with audio, video recording
Exclusion criteria
Exclusion criteria: • Patient not willing to comply with the study procedure • Females who are pregnant or breast-feeding • Skin diseases other than acne vulgaris • Use of other topical or systemic treatments for acne • Other significant medical conditions or clinically significant abnormal laboratory test results • History of alcoholism or substance abuse and any other liver abnormalities • Conditions in the opinion of the investigator make the patient unsuitable to participate in the study. • History of Hormone-sensitive condition such as breast cancer, uterine cancer, ovarian cancer, endometriosis, or uterine fibroids • Patients under medication with contraceptive pills, Diltiazem, Anticoagulant and Propranolol. • History of hypothyroidism or hyperthyroidism • History of HIV • Participation in another trial within 3 months prior to informed consent • Certain medications that may interfere with the study medication (these will be identified by the study doctor).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Percent reduction in inflammatory Acne lesion counts (Baseline to EOT) â?¢ Reduction in white and black heads (Baseline to EOT) â?¢ Changes in blood investigations Timepoint: Screening to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Investigators overall assessment of facial acne using Four-point scale ranging from â??excellentâ?? to â??poorâ?? response Investigator Global Assessment (IGA) (appendeix-1) â?¢ Subject QOL Questionnaire â?¢ No. of adverse events captured. Timepoint: Screening to day 90 | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed