Studying the Effectiveness of Herbal Extract Blend for Stress and related conditions.

Phase 2

Conditions: Health Condition 1: Z733- Stress, not elsewhere classified

Registration Number: CTRI/2023/09/057801

Lead Sponsor: isarga Biotech Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Perceived stress scale (PSS) score by perceived stress questionnaire will be assessed from screening to day 63 <br/ ><br>2.Cortisol and dopamine levels will be assessed at screening, day 28, day 63Timepoint: screening, baseline, day 28, day 36, and day 63

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in- <br/ ><br>1.Subject -reported time to sleep onset (as per subject diary), changes in sleep latency, sleep efficiency (Total sleep time divided by time in bed and multiplied by 100), and subject -reported number of awakenings derived from the subject diary at day 28, day 36 and day 63 <br/ ><br>2.Severity of insomnia using the Insomnia Severity Index Scale will be assessed from screening to day 63 <br/ ><br>3.Daytime fatigue using Fatigue Severity Scale (FSS) will be assessed from screening to day 63 <br/ ><br>4.Measurement of mood on the POMS scale (Profile of mood state questionnaire) will be assessed from screening to day 63 <br/ ><br>5.Changes in anxiety by using Hamilton Anxiety Rating Scale (HAM-A) score will be assessed from screening to day 63 <br/ ><br>Timepoint: screening, baseline, day 28, day 36, and day 63