A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of MUKUL PURE in treating Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VIdya Herbs
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Percent reduction in inflammatory Acne lesion counts (Baseline to EOT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
•Percent reduction in inflammatory Acne lesion counts (Baseline to EOT)
时间窗: Screening to day 90
•Reduction in white and black heads (Baseline to EOT)
时间窗: Screening to day 90
•Changes in blood investigations
时间窗: Screening to day 90
次要结局
- •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)