RecruitingACTRN12609000015246

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

Sponsor

Natural Health Products Pty Ltd

Enrollment

110 participants

Start Date

Sep 23, 2008

Study Type

Interventional

Conditions

Mild to moderate depression and anxiety

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.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a herbal supplement called 30Plus to see if it can help younger women who are dealing with mood swings, anxiety, or other emotional symptoms. For 12 weeks, participants will take either the herbal tablets or a placebo (a dummy pill with no active ingredients) — two tablets every day. Every 4 weeks, you will fill out a short questionnaire about how you are feeling. Neither you nor the researchers will know which group you are in until the study ends. You may be eligible if: - You are a woman between 18 and 45 years old - You have noticed at least one of the following over the past 3 to 6 months: depression, angry outbursts, irritability, anxiety, confusion, or withdrawing from others You may NOT be eligible if: - You have severe depression - You are currently taking any substances known to affect mood Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.

Locations(1)

Australia

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ACTRN12609000015246