Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) Standardized Root Extract for Treatment of Menopausal symptoms in women: A Prospective, Randomized, Double-Blind, Placebo Controlled Study

Ixoreal Biomed Private Limited0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•–Menopausal women aged 45 to 65 years with intact uterus and ovaries
•–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
•–Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
•–Body mass index 18-35 kg/m2
•–Subject who has given written informed consent to participate in the study and understand the nature of the study
•–Able to read and write in English or any other vernacular language

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

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