Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

Ewha Womans University

Status: Completed

Conditions: Healthy Adults With Subjective Sleep Complaints

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Polygonatum sibiricum

Study type: Interventional

Funder types: Other

Identifiers

NCT03337789

PSE

Details and patient eligibility

About

This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.

Enrollment: 80 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female volunteers who are between the ages of 20 and 65
• Experienced any of the following sleep problems, at least more than once a week for more than 2 months: 1) difficulty in falling asleep or staying asleep; 2) waking up at dusk and not being able to fall asleep again; 3) not feeling refreshed even after getting some sleep.

Exclusion criteria

• Diagnosed with insomnia assessed with a structured interview and sleep scale measurements
• Possibility of drug-induced sleep disorders due to current intake of medication (i.e., corticosteroid, statin, etc)
• Had taken sleeping pills (i.e., zolpidem, benzodiazepine) during the past 2 months
• Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests.
• Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument
• A history of traumatic brain injury with loss of consciousness, or any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in body)
• Had taken psychotropic drugs within the past 3 months before study participation
• Allergic to polygonatum sibiricum or experienced side effects after consumption of any product containing polygonatum sibiricum
• Participated in another clinical trial or took other medications during the period that may influence the results of this clinical trial
• Currently taking contraceptive pills
• Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Polygonatum sibiricum

Experimental group

Treatment:

Dietary Supplement: Polygonatum sibiricum

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo