Evaluation of Efficacy and Safety of extract of Ashwagandha (Withania somnifera) Standardized Extract in Women with Perimenopausal Symptoms: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Dr D Y Patil Medical College Hospital and Research Center0 个研究点目标入组 100 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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•1. Perimenopausal women with intact uterus and ovaries
•2.Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
•3.Females with complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
•4.Body mass index 18-35 kg/m2
•5.Subject who has given written informed consent to participate in the study and understand the nature of the study
•6.Not illiterate

•1.Taking any form of herbal extract in the last 3 months before study entry
•2.On hormone replacement therapy for more than 3 months
•3.Present active medical, surgical and gynecological problems
•4.History of drug or alcohol abuse
•5.Ovariectomy
•6.History of breast or cervical carcinoma
•7.Taking medication that affect bone metabolism, including glucocorticoids, anticonvulsant and methotrexate
•8.Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
•9.Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
•10.Evidence of uncooperative attitude, including poor compliance
•11.Inability to attend follow-up visit
•12.Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective

发起方

Dr D Y Patil Medical College Hospital and Research Center