None listed
Conditions
Brief summary
This will be a blinded, placebo-controlled clinical trial conducted within natural medicine clinics. Initial screening and consenting of participants will be conducted by the Co-Investigator and participants allocated to individual naturopathic clinicians for assessment interviews. The study includes two active treatment options and a placebo control. Participants will be allocated into Treatment Arm #1 or Treatment Arm #2 based on their initial clinical presentation, categorised into either an ‘anxiety-driven’ stress type (Treatment Arm #1) or a ‘non-anxiety driven’ stress type (Treatment Arm #2). Participants will be tested for stress, depression and anxiety indices at baseline and at day 21 for changes in these areas.
Interventions
Treatment Arm 1 - Herbal tablet containing: Ziziphus jujuba var. spinosa (Ziziphus), Passiflora incarnata (Passionflower), Melissa officinalis (Lemon balm) and Matricaria chamomilla (Chamomile). Three tablets daily, orally, in divided doses, for 21 days.
Treatment Arm 2 - Herbal tablet containing: Withania somnifera (root) and Crocus sativus (stigma). Two tablets daily, orally, in divided doses, for 21 days.
Participants in Treatment Arm #1 will be directed to take , one in the morning, one
Treatment Arm 1 - Herbal tablet containing: Ziziphus jujuba var. spinosa (Ziziphus), Passiflora incarnata (Passionflower), Melissa officinalis (Lemon balm) and Matricaria chamomilla (Chamomile). Three tablets daily, orally, in divided doses, for 21 days. Treatment Arm 2 - Herbal tablet containing: Withania somnifera (root) and Crocus sativus (stigma). Two tablets daily, orally, in divided doses, for 21 days. Participants in Treatment Arm #1 will be directed to take , one in the morning, one in middle of day, and one in the evening. Participants in Treatment Arm #2 will be directed to take two tablets, orally, daily, one in the morning, and one in the evening. Compliance will be assessed through returned tablet count on completion of study.
Sponsors
Integria Healthcare (Australia) Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Outcome results
None listed