A PROSPECTIVE, OPEN-LABELLED, PROOF-OF-CONCEPT, COMPARATIVECLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THECOMBINATION THERAPY OF SUVENTRIS SYRUP AND CYSTEVITTABLETSCOMPARED WITH STANDARD OF CARE IN ADULT WOMEN DIAGNOSEDWITH POLY-CYSTIC OVARIAN SYNDROME

Jammi Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Young women of age between 18 to 40 yrs. diagnosed withPCOS
•2.Sub-fertilefemales
•3.Polycystic ovaries with exclusion of otheraetiologies
•4.Women with normal uterinecavity
•5.Subjects with history of Impaired Glucose Tolerance or Insulin Resistance with PCOS
•6.Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, haematology routine urinalysis and measurement of oral temperature and vitalsigns.

•1.Pregnant or lactatingwomen.
•2.Subjects with presence of infertility factors other thananovulation
•3.Subjectswithpelvicorganicpathologies,presenceofotherpathologiessuchasnon- classical congenital adrenal hyperplasia, Cushing’s syndrome and androgen secretingtumours
•4.Subjects with thyroid dysfunction, hyperprolactenemia, androgen secreting neoplasia.
•5.Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonaldrugs.
•6.Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e., type 1 or type 2 diabetes, renal disease, and mal- absorptivedisorders,acuteandchronicinflammations)confirmedbasedonmedical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count andurinalysis.
•7.Subjects with known history of hypersensitivity to the studydrugs.
•8.Alcoholic consumers andsmokers

发起方

Jammi Pharmaceuticals Pvt Ltd