A single centre, double blind, placebo-controlled clinical study design in healthy subjects to evaluate the efficacy of dietary supplement to alleviate stress in subjects with mild to moderate stress
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
The anti-stress supplement was developed to provide relief from anxiety and depression levels.Subjects were given 60 capsules of calming supplement (30-day supply) and instructed to take two capsules each day orally with water.
Subjects were given 60 capsules of placebo (30-day supply) and instructed to take two capsules each day orally with water.
PCR Corp
Manchester, United Kingdom
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
Hamilton Anxiety Rating Scale (HAM-A) (1) was assessed using a questionnaire and scored on a scale of 0 to 4, with 0 (no presence of anxiety) to 4 (severe anxiety). (1) Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 1959, 32, 50-55.
Time frame: 30 days
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
Hamilton Depression Rating Scale (HDRS) (1) was assessed using a questionnaire and scored using a scale of 0 to 20, with 0-7 (within normal range or remission) while a score of 20 (indicating moderate depression. (1) Hamilton, M. A rating scale of depression. J. Neurol. Neurosurg. Psychiatry, 1960, 23, 56-62.
Time frame: 30 days
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)
Perceived stress was assessed with Perceived Stress Scale (PSS) using a validated questionnaire on a score of 0 to 40, with 0 (no stress) and 20 or above (higher perceived stress) at day 1, day 7 and at day 30.
Time frame: 30 days
Assessment of mood using Profile of Mood States (POMS) scale
Assessment of Profile of Mood States (POMS) was measured on a 5 point scale of 0 to 5, with 0 (not at all moody) to 4 (extremely moody),
Time frame: 30 days
Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale
Restorative Sleep Questionnaire, Weekly (RSQ-W) is a nine-item survey that measures how restful a person feels after sleeping for the past week. The RSQ-W scale scores range from 0-100, with higher scores indicating more restorative sleep. To convert the average score to a 0-100 scale, use the formula: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1.0}\*25.
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Time frame: 30 days