Comparative Clinical Assessment of Two Polyherbal Formulations in Menstrual Health – A Proof of Concept - NI

Dabur India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1.Provision of signed and dated informed consent prior to any study-specific procedures.
•2.Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of PMS
•3.Females with irregularity menstrual cycles (based on history)
•4.Not on any hormonal therapy during and one month prior to the trial.
•5.Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable)
•6.Willing to follow study related procedures.

•1.Subjects not willing to sign ICD.
•2.Menopausal or peri-menopausal based on history
•3.Currently pregnant or breastfeeding
•4.Planning pregnancy in next 3-4 months
•5.Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.
•6.Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc)
•7.Gynaecological conditions like genital tuberculosis, history of any malignancy or organic lesions like polyps, fibroids, endometriosis etc. on USG
•8.Prescence of chronic systemic conditions like endocrinal disorder like Cushing’s syndrome, hypertension, heart diseases, diabetes, hepatic disease, renal disease, or any psychiatric condition (medical history)
•9.Subjects who in Investigators’ opinion will not be able to follow study related procedures.

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