SAFETY STUDY OF CFE (COLEUS FORSKOHLII EXTRACT) WITH 30% FORSKOLIN AS A WHOLE RAW MATERIAL IN HEALTHY HUMAN.

PIONEER EXTRACTS PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Ã¢â?¬Â¢Male or female subjects between 20 to 50 years of age
•Ã¢â?¬Â¢Subject with BMI value less than 30 kg/m2
•Ã¢â?¬Â¢Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera Ã?Â®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
•Ã¢â?¬Â¢Subject should be available for duration of study period (2-3 months)
•Ã¢â?¬Â¢Subject agrees to come to site in fasting state for their physical, medical and other laboratory parameters examination at all the scheduled visits.
•Ã¢â?¬Â¢Subjects willing to give written informed consent and willing to comply with trial protocol.

•Ã¢â?¬Â¢Subjects having headache, diarrhea, hypertensive, and alcoholic physical constitutions
•Ã¢â?¬Â¢Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain two months prior to screening.
•Ã¢â?¬Â¢Subjects having history of asthma
•Ã¢â?¬Â¢Subjects having history of cardiovascular diseases
•Ã¢â?¬Â¢Subjects having history of diabetes (Type I or Type II)
•Ã¢â?¬Â¢Subject with Hyperuricaemia (males > 480 Ã?Âµmol/L, females > 450 Ã?Âµmol/L)
•Ã¢â?¬Â¢Subjects having thyroid diseases
•Ã¢â?¬Â¢Subjects having abnormal liver or kidney function tests
•Ã¢â?¬Â¢Subjects having abnormal findings on complete blood count
•Ã¢â?¬Â¢Subjects having history of coagulopathies
•Ã¢â?¬Â¢Subjects with hypertension
•Ã¢â?¬Â¢Subjects with HIV Positive
•Ã¢â?¬Â¢Subjects having history of congestive heart failure

发起方

PIONEER EXTRACTS PVT LTD