A prospective open label study to evaluate the safety, efficacy of KAL-HS-05 in the Management of Insomnia (Nidranasha) - NI

Kerala Ayurveda Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

研究概览

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•1.Willing to give informed consent.
•2.Healthy Indian male/ female volunteer aged between 18-65 years.
•3.Must be able to adhere to the study visit schedule and other protocol requirements.
•4.Willing to complete the questionnaires for the total duration of treatment.
•5.Patients suffering from insomnia/loss of sleep from last 1 month.
•6.Willing to avoid usage of any NSAIDs, Sleep inducing medication, etc. during the study duration.
•7.Agree not to use any medication (prescription and over the counter), during the course of this study

•1.Patients on Psychiatry medicine.
•2. Patients on hypnotic medicine or any other drugs known to cause drowsiness.
•3.Pregnant or Breast feeding.
•4.Inability to provide voluntary consent.
•5.Patients with pre-existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication.
•6.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
•7.Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
•8.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
•9.Use of any anti-psychotic drugs for one week prior to Baseline.
•10.Subjects who abuse drugs or alcohol drug screening not required.
•11.Use of any investigational medication within 4 weeks prior to start of study drug.
•12.Greater than moderate alcohol use

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