A randomised control trial on the effect of a herbal product, 30Plus, on mood swings and anxiety in younger women

In women aged 18-45 years with mild to moderate depression and anxiety, are 2 tablets daily of 30Plus more effective than placebo in reducing depression and anxiety symptoms

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000015246

Enrollment

110

Registered

2009-01-08

Start date

2008-09-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study will evaluate how effective a herbal formulation is in decreasing psychological symptoms such as anxiety and depression. The study will run for 12 weeks in total, and over that time participants will be asked to complete one questionnaire every 4 weeks to evaluate their symptoms of depression and anxiety. Half the women in the study will take 2 tablets daily of the study product while the other half will take 2 placebo tablets. A placebo is a dummy treatment, which looks and tastes like the real medication, but contains no active ingredient.

Interventions

Two tablets daily of 30Plus to be taken orally over 8 weeks. 30Plus Each tablet of 30Plus contains the following active ingredients: Tyrosine 150mg Cimicifuga racemosa extract, (Equivalent to dry rhizome 60mg) Pyridoxine HCl 25mg Folic acid 100mcg Cyanocobalamin 150mcg Chromium picolinate 200mcg (Equivalent to Chromium 25mcg) Calcium hydrogen phosphate 25mg (Equivalent to Calcium 6mg) B group vitamins are commonly taken by women who suffer from premenstrual syndrome (PMS) and systematic reviews have shown that vitamin B6, in particular, is an effective treatment for both the physical and psychological symptoms. Black cohosh extracts have been used traditionally to treat PMS and menopause symptoms. A recent large randomised controlled trial has shown that black cohosh extract is an effective treatment for menopause symptoms, including psychological symptoms. Chromium supplements have been variably shown to improve glucose metabolism and might help reduce sugar cravings. Tyrosine appears to prevent the substantial decline in various aspects of cognitive performance and mood associated with many kinds of acute stress.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Have noticed at least one of the following psychological symptoms over the 3-6 months prior to screening: - Depression - Angry outbursts - Irritability - Anxiety - Confusion - Social withdrawal

Exclusion criteria

Severe depression, or any current use of substances known to affect mood.

Outcome results