PCR Corp
Manchester, M13 0AF, United Kingdom
NCT Number: NCT06672965
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
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Notify Me40 year–45 year
All sexes
Interventional
Not applicable
Manchester, M13 0AF, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
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
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
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 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
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.
Pharmanex
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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