CTRI/2023/09/057801
Not yet recruiting
Phase 2
Clinical validation of the potential of herbal extract blend in alleviating the stress and related conditions: A randomized, placebo-controlled, cross-over clinical study. - Nil
isarga Biotech Pvt. Ltd.0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z733- Stress, not elsewhere classified
- Sponsor
- isarga Biotech Pvt. Ltd.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Participants aged greater than or equal to 30 and less than 60 years at the time of obtaining written informed consent;2\)Participants diagnosed with primary insomnia 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 willing to sign inform consent form;5\)A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period;6\)Subjects with a score of 14\-26 on the Perceived Stress Scale (PSS);7\)Willing to limit alcohol, caffeine, and nicotine consumption while in the study;8\)Free of psychiatric conditions other than perceived stress.
Exclusion Criteria
- •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 clinical depression and anxiety disorder (showing moderate to severe diagnosis on PHQ 9 and GAD 7 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 15 cigarettes a day
- •9\.History of malignancy less than or equal to 5 years prior to signing an informed consent
- •10\.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.
Outcomes
Primary Outcomes
Not specified
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