An Open Label, Prospective, Multi-Centric, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of an Ayurvedic Formulation in the management of Primary Dysmenorrhea in Female Adults.

Ms Cavinkare Research Centre0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Healthy women ages 18-40 (both ages inclusive) with a history of Primary Dysmenorrhea (onset of symptoms < 12 months after menarche).
•2. Regular menstrual cycles for atleast 6 months (once in 28-35 days with each cycle lasting a minimum of 3 days.)
•3.Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive)
•4. Subjects who score either â??Moderateâ?? or â??Severeâ?? in the Severity Assessment during Visit 0.
•5.Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.

•1.Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).
•2.Concomitant treatment with oral contraceptives, Gonadotrophinreleasing hormone agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs.
•3.Recent history of abdominal surgery in the last 6 months.
•4.Unevaluated gynecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia)
•5.Gross developmental defect or congenital abnormalities of uterus
•6.Patients with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities.
•7.Pregnant & nursing women or women who have given birth or had a miscarriage within the last 6 months.
•8.Women who have undergone hysterectomy.
•9.Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.
•10.Perimenopausal and Menopausal women.
•11.Known or suspected hypersensitivity to herbal products.

发起方

Ms Cavinkare Research Centre