None listed
Conditions
Brief summary
This trial evaluates the efficacy of two herbal medicines and a B-vitamin complex for improving stress and anxiety in adults who experienced elevated stress post-flooding natural disaster in the Northern Rivers Area of Australia. A total of 100 participants will be randomly allocated to one of four arms, and three out of these will receive the intervention for a total of 6 weeks each. The primary outcome is feasibility of study procedures and interventions. Perceived stress will be measured at the beginning and each 2 weeks until the end of the 6 weeks, and other mental health/quality of life measures will be included at baseline and 6 weeks.
Interventions
Three different interventions, herbal and nutritional supplements. Each participant will only receive one of the interventions. Adherence and compliance are measured via diary, and at Week 6 with a final tablet count at the telehealth visit.
Arm 1: Noble Kava (Fijikava), listed medicine
Per capsule: Piper methysticum (Kava) ext. dry conc – 695 mg from minimum fresh root – 6.95 g, standardised to contain Kavalactones (per capsule) –50 mg.
Dose: 200mg daily, oral (2 capsules twice daily)
Duration
Three different interventions, herbal and nutritional supplements. Each participant will only receive one of the interventions. Adherence and compliance are measured via diary, and at Week 6 with a final tablet count at the telehealth visit. Arm 1: Noble Kava (Fijikava), listed medicine Per capsule: Piper methysticum (Kava) ext. dry conc – 695 mg from minimum fresh root – 6.95 g, standardised to contain Kavalactones (per capsule) –50 mg. Dose: 200mg daily, oral (2 capsules twice daily) Duration: 6 weeks Arm 2: Executive B Stress Formula (Blackmores), Listed Medicine Per tablet: - Thiamine hydrochloride (thiamine vitamin B1 66.9mg) 75 mg - Riboflavin (vitamin B2) 10 mg - Nicotinamide 100 mg - Calcium panthothenate (pantothenic acid 68.8 mg) 75 mg - Pyridoxine hydrochloride (pyrdioxine 20.6 mg) 25 mg - Cyanocobalamin (vitamin B12) 30 micrograms - Biotin (vitamin H) 20 micrograms - Calcium ascorbate dehydrate 145.5 mg - Ascorbic acid 130 mg (total vitamin C 250 mg) - D-alpha tocopheryl acid succinate (vitamin E 50 U) 41.3 mg - Magnesium phosphate pentahydrate (magnesium 28.9 mg) 140 mg - Calcium phosphate (calcium 37 mg) 95.6 mg - Monobasic potassium phosphate (potassium33.7 mg) 117 mg - Folic acid 150 micrograms - Avena sativa (oats) extract dry conc. 25 mg (equiv. to dry seed 250 mg) - Passiflora incarnata (passion flower) extract dry conc. 20 mg (equiv. to dry herb 100 mg) - Choline bitartate 25 g Dose: 2 tablets daily, oral (1 tablet twice daily) Duration: 6 weeks Arm 3: Ashwagandha Complex Day, listed medicine Per capsule: Bacopa monnieri whole plant Extract dry concentrate 150 mg equivalent: Bacopa monnieri (Dry) 3000 mg, Withania somnifera root Extract dry concentrate 150 mg equivalent: Withania somnifera (Dry) 1.5 g Dose: 4 tablets daily, oral (2 tablets twice daily) Duration: 6 weeks
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older Resident in the flood affected area in the Norther Rivers and Regional New South Wales Have self-reported significant increase in post flood stress and/or anxiety within 12 months Mild to moderate perceived stress (PSS 14-26 pts)
Exclusion criteria
- Pregnancy or breastfeeding - Severe mental health, including major depression with or without suicidal ideation (PTSD accepted if stable ongoing psychological care) - Neurological disorders - Serious medical conditions, acute or chronic - Liver disease (diagnosed, or elevated liver enzymes (greater than 1.2xULN) - Alcohol use disorder (high-risk consumption) - Concurrent use of any medication judged to have a clinically significant potential for interactions with the herbal medicines - Current use of trial products - Use of psychotropic medication - Use of psychoactive herbal medicines (a 1-week washout is acceptable) - Current oral steroid administration - Current chemotherapy, radiation, immune suppressant therapy, or immunotherapy - Current warfarin administration - Limited ability to read, speak, write, or understand English to ensure participant understanding of all aspects of the study
Outcome results
None listed