Clinical study on Passiflora Extract in tension and sleep problem

Phase 2/3

Completed

Conditions: Insomnia, (2) ICD-10 Condition: Z733||Stress, not elsewhere classified,

Brief Summary: It is a randomized, double blind, placebo controlled, multi-centric,interventional, prospective clinical study to evaluate efficacy and safety of *Passiflora incarnata* (Aerial Parts) Extract in participantswith stress and insomnia. As per computer generated randomization list, participants will berandomized either to *Passiflora incarnata* (Aerial Parts) Extract group orplacebo group in 1:1 ratio. Dose of Passiflora extract will be 600 mg at bedtime with water for 30 days. The primary objectives of the study will be to assessstress and patient-reported total sleep time. The secondary objectives of the study will beto assess general psychological health, sleep efficiency, subject-reportedtime to sleep onset, patient- reported number of awakenings, patient -reportedwake time after sleep onset, severity of insomnia, serum cortisol (morning)level, daytime fatigue, daytime mood, ability to function at work,concentration and memory, quality of sleep, requirement of rescue medications(sedatives), adverse events and vitals, safety lab parameters on screeningvisit, day 0, day 15 and day 30

Recruitment & Eligibility

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

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.
Known cases of severe or chronic hepatic or renal disease.
Subjects giving history of significant cardiovascular event less than12 weeks prior to recruitment.
Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
Known cases of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
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.
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.

Primary Outcome Measures

Name	Time	Method
1.Change in stress	Screening visit, Day 0, Day 15 and Day 30
2.Change in Patient-reported total sleep time	Screening visit, Day 0, Day 15 and Day 30

Secondary Outcome Measures

Name	Time	Method
1.Change in general psychological health	2.Change in sleep efficiency

Locations (2): D. Y. Patil University School of Ayurveda
🇮🇳
(Suburban), MAHARASHTRA, India
KVTR Ayurvedic College and Hospital Boradi
🇮🇳
Dhule, MAHARASHTRA, India
D. Y. Patil University School of Ayurveda
🇮🇳(Suburban), MAHARASHTRA, India
Dr Maheshkumar Harit
Principal investigator
9322217607
drmaheshkharit@rediffmail.com