Phase 1 clinical trial to determine safety of a herbal formulation LLC in healthy human volunteers.

ink Natural Products (Pvt) Limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. The volunteers provides written informed consent before starting the study.
•2. Volunteers who are in the age group 18 years to 60 years, healthy as defined by history, examination and systolic and diastolic blood pressure, and those who have normal baseline investigations, those who have normal liver function (serum bilirubin, AST, ALT, ALP, GGT, Serum albumin, FBS, coagulation tests (PT/INR)), renal function (urine full report, serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan will be recruited to the study.
•3. Both male and unmarried female volunteers will be recruited to the study.
•Any female volunteer planning to get married during the 4 months after recruitment to the study will excluded from the study.

•1. Volunteers with a history of chronic illness such as diabetes mellitus, hypertension, cardiovascular diseases, chronic liver and kidney disease, and any other disease that warrants long term medication (e.g., autoimmune disease).
•2. Volunteers who have abnormal baseline investigations by history, examination, systolic and diastolic blood pressure, and those who have abnormal liver function (serum bilirubin, AST, ALT, ALP, GGT, serum albumin, FBS, coagulation tests (PT/INR)), renal function (Urine full report, Serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan would be excluded from the trial.
•3. Volunteers on any medicines, including nutritional, Ayurveda/ herbal supplements.
•4. Married women volunteers and any women planning to get married during the 4 months after recruitment to the study.
•5. Allergies or allergic reactions to any of the ingredients of LLC.

发起方

ink Natural Products (Pvt) Limited