A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of MUKUL PURE in treating Acne
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- VIdya Herbs
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- •Changes in blood investigations
Study Overview
Brief Summary
AProspective, Randomized, Double blind, Placebo controlled clinical trial toevaluate efficacy and safety of MUKUL PURE in treating Acne.
Primaryobjectives:Toevaluate the efficacy of MUKUL PURE capsule in treating AcneSecondaryobjectives:Toevaluate the safety of MUKUL PURE capsule in treating Acne
Primary outcomes· Percent reduction in inflammatory Acne lesion counts (Baseline to EOT)· Reductionin white and black heads(Baseline to EOT)· Changes in blood investigations(Baseline to EOT)Secondary outcomes· Investigatorsoverall assessment of facial acne usingFour-point scale ranging from ‘excellent’ to ‘poor’response Investigator GlobalAssessment (IGA) (appendeix-1)· SubjectQOL QuestionnaireNo.of adverse events captured.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢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
- •â€¢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.
- •â€¢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.
- •â€¢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).
Outcomes
Primary Outcomes
•Changes in blood investigations
Time Frame: Screening to day 90
•Percent reduction in inflammatory Acne lesion counts (Baseline to EOT)
Time Frame: Screening to day 90
•Reduction in white and black heads (Baseline to EOT)
Time Frame: Screening to day 90
Secondary Outcomes
- •Investigators overall assessment of facial acne using Four-point scale ranging from ‘excellent’ to ‘poor’ response Investigator Global Assessment (IGA) (appendeix-1)(•Subject QOL Questionnaire)