Effectiveness of herbal formulations for stress

Phase 2

Conditions: Stress
Alternative and Complementary Medicine - Herbal remedies
Mental Health - Anxiety

Registration Number: ACTRN12623000287639

Lead Sponsor: Integria Healthcare (Australia) Pty Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: All

Target Recruitment: 94

Inclusion Criteria

Healthy adults (18-75 years)
-- Any allowable prescription medication use by participants must be stable for four weeks or more prior to trial entry
-- Score of 13 or more on the Perceived Stress Scale (PSS-10)

Exclusion Criteria

-- Diagnosed depression or anxiety for which person is taking medication or has ceased taking medication within the last four weeks
-- Diagnosed with any of the following medical conditions: cancer (if active within last 5 years and excepting skin cancer), liver or kidney disease, neurological disease
-- Currently unwell with acute infection or fever
-- Having contracted confirmed Covid-19 in the four weeks prior to enrolment
-- In poor general health
-- Taking any of the following medications: anti-depressants; any type of neuro-active medications, i.e. mood stabilisers, stimulants, anti-psychotics; warfarin or anti-coagulant medications, cyclosporin
-- Current use of any herbal medicine or nutrients targeted for mood, stress or mental health (eligibility of participants taking any supplements will be at discretion of enrolling practitioner)
-- Pregnant or breastfeeding or planning pregnancy
-- Allergy/sensitivity to study drugs or their formulations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stress, depression and anxiety indices assessed using the Depression, anxiety, stress scale (DASS-21). Analysed as a composite outcome (change in overall DASS-21 score)[ Baseline and day 21 after treatment randomisation]

Secondary Outcome Measures

Name	Time	Method
Change in stress levels assessed using the Perceived Stress Scale (PSS) [ Baseline and day 21 after treatment randomisation];Change in sleep assessed using PROMIS Sleep Scale - adult short-form (PROMIS) [ Baseline and day 21 after treatment randomisation];Change in anxiety assessed using Zung Self-Rating Anxiety Scale (Zung) (assessed in Treatment Arm #1 only)[ Baseline and day 21 after treatment randomisation];Patient Global Impression of Change[ Baseline and day 21 after treatment randomisation]