Health Condition 1: G470- Insomnia Health Condition 2: Z733- Stress, not elsewhere classified
Conditions
Interventions
Intervention1: Capsule containing Passiflora incarnata (Aerial Parts) Extract â?? 600 mg: Dose and Duration: 1 capsule at bedtime for 30 days
Control Intervention1: Placebo Capsule: Dose and duration:
Sponsors
JK Botanicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Literate subjects who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS) 2. Subjects with insomnia severity more than 7 and equal to 21 on insomnia severity index 3. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects suffering from any known chronic physical, hormonal or psychiatric illness 2. Subjects using oral or systemic contraceptive medications 3. Subjects with uncontrolled diabetes and hypertension 4. Subjects with substance dependence 5. Chronic alcoholics and Habitual Tobacco chewers. 6. Known cases of severe or chronic hepatic or renal disease. 7. Known case of any active malignancy. 8. Subjects giving history of significant cardiovascular event less than12 weeks prior to recruitment. 9. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 10. Known cases of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 11. Subjects using any other investigational drug within 1 month prior to recruitment or subjects currently participating in any other Clinical study 12. Known hypersensitivity to any of the ingredients used in study products 13. Pregnant and Lactating females. 14. Other conditions, which in the opinion of the investigators, make Subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in stress 2.Change in Patient-reported total sleep time Timepoint: Screening visit, Day 0, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in general psychological health 2. Change in sleep efficiency 3. Change in Subject-reported time to sleep onset, patient- reported number of awakenings, patient -reported wake time after sleep onset 4. Change in severity of insomnia 5. Post study change in serum cortisol (morning) level 6. Change in daytime fatigue, daytime mood, ability to function at work, concentration and memory, quality of sleep 7. Assessment of requirement of rescue medications (sedatives) 8. Assessment of adverse events, vitals and safety lab parameters. 9. Global assessment for overall change by participants and by physician Timepoint: Screening visit, Day 0, Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed