Randomized, placebo controlled clinical trial to assess the efficacy and safety of NRL/WW/19-20 to promote health and wellbeing in woman in fertile age - NI

etsurf Communications Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Fertile Women Aged 18 - 50 years
•BMI in the range of 20-26 Kg/m2 should be incorporated
•With or without painful menstruations for at least three consecutive cycles with regular menstrual cycles having normal bleeding phases (21-35 days)
•Not associated with any organic reproductive system abnormalities (excluded clinically and radiologically as per history)
•Subjects having good physical condition and sound mental status.
•In the judgment of the Principal Investigator, able to comply with protocol requirements.
•Subjects willing to sign written informed consent Willing to abstain from use of additional vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.

•Subjects with uncontrolled diabetes and diabetes with renal dysfunction.
•Cases of secondary dysmenorrhea
•Abdominal pain associated with excessive vaginal bleeding
•Known cases of ovarian cysts endometriosis
•Associated with pelvic inflammatory diseases (PID Hydrosalpinx)
•History of malignancy of pelvic organs
•History of hypo and hyper thyroidism
•Uncontrolled Hypertensive subjects
•Presence of any major illness such as cancer, heart disease, COPD, Asthma etc.
•Subjects with medical history of any major illness such as cancer, heart disease, COPD, Asthma etc. in the past
•Subjects with history of any acute or chronic illness that may affect the patientâ??s participation in the study
•Use of prescription medications and/or nonprescription medications for weight loss.
•Subjects with acute illness or history of major or minor surgery in the past one year.
•Female subjects who are currently pregnant and/or breast feeding
•Subjects not willing to participate in study.
•Subjects with history of hysterectomy, IUI and IVF or oral contraceptive pills (OCP)
•Subjects with PCOS and or on any hormone replacement therapy

发起方

etsurf Communications Pvt Ltd