Clinical validation of efficacy and safety of Blessful Sleep Gummies (BSG) in subjects suffering from insomnia disorder. - NI

Aesthetic Nutrition Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•1. Male and female aged 25-40 years (both inclusive) at the time of obtaining written informed consent; 2. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR); 3. Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate; 4. Subjects with a diagnosis of mild or moderate depression (patientsâ?? health questionnaire (PHQ-9) score of less than or equal to 14); 5. Subjects with a diagnosis of mild or moderate generalized anxiety disorder (GAD) -7 questionnaire score of less than or equal to 10; 6. Subjects willing to sign inform consent form;7. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period;8. Willing to limit alcohol, caffeine, and nicotine consumption while in the study.

•1. Difficulty sleeping due to a medical condition;
•2. History of a neurological disorder;3. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication;
•4. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score more than or equal to 15 and GAD-7 score more than or equal to 11 scales); 5. History of substance abuse or dependence;6. History or current evidence of a clinically significant cardiovascular disorder at pre-study visit;7.Taking certain prohibited medications;8. Consumption of more than 10 cigarettes a day; 9. History of malignancy less than or equal to 5 years prior to signing informed consent and current evidence of cancer;10. Known hypersensitivity to any ingredients of BSG;
•11. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

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