An Exploratory, Open Label study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia

Enovate Biolife Pvt Ltd0 个研究点目标入组 20 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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•Case of primary Insomnia as diagnosed by the investigator
•- Sleep disorder indicated by one or more of the following:
•- History of sleep duration of less than 4.5 hrs/ night
•- History of sleep latency of >= 60 min
•- History of tiredness post awakening
•- History of presence of above symptoms for >= 6 months.
•- Able and willing to follow all study related instructions and to make all required visits

•- Subjects not willing to discontinue insomnia medication
•- Secondary forms of insomnia
•- Concurrent history/ treatment of acute psychiatric illness (such as schizophrenia, acute panic attack, major depressive disorder etc.).
•- Subjects with history of a substance use disorder
•- History of uncontrolled diabetes, hypertension and other metabolic disorder.
•- Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
•- Pregnant / lactating women and women who are planning to get pregnant
•- Recent (within last 3 months) participation in a clinical trial
•- Recent (within last 15 days) use of any, herbal or homeopathic product for the insomnia.
•- A medical condition, which in the Investigatorâ??s opinion may pose a threat to patient compliance e.g. case of seizures.
•- Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study

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