None listed
Conditions
Brief summary
Experiencing menopausal symptoms can be distressing for women, particularly when they start to occur when they have important roles in society, within the family and the workplace. This is an online telehealth clinical trial for ladies experiencing menopausal symptoms. It is a randomised trial with the intervention which is a herbal capsule or a placebo. The trial goes for 12 weeks per person.
Interventions
The intervention is Happy hormones:
Dose: 4 capsules daily (equivalent to 5grams) - 2 capsules with breakfast, and 2 capsules with dinner
Duration: 12 weeks.
The herbal formulation of Happy Hormones consists of whey protein, liquorice root powder, maca, psyllium husks, natural vanilla flavour, red clover powder, passion flora powder, sage powder, guar gum, natural berry flavour, wild yam powder, raspberry leaf powder, gymnema sylvestre extract, dandelion root extract, black cohosh extract,
The intervention is Happy hormones: Dose: 4 capsules daily (equivalent to 5grams) - 2 capsules with breakfast, and 2 capsules with dinner Duration: 12 weeks. The herbal formulation of Happy Hormones consists of whey protein, liquorice root powder, maca, psyllium husks, natural vanilla flavour, red clover powder, passion flora powder, sage powder, guar gum, natural berry flavour, wild yam powder, raspberry leaf powder, gymnema sylvestre extract, dandelion root extract, black cohosh extract, chaste berry extract and stevia extract. Each 5g of powder contains: Salvia officinalis (Garden Sage) ext equiv to dry leaf 3g. Vitex agnus-castus (Chaste Berry) ext equiv to dry fruit 2g Actaea racemose (Black Cohosh) ext equkiv to dry rhizome 280mg standardized to triterpene glycosides 1mg. Passiflora incarnata (Passion Flower), et equiv to dry herb flowering and fruiting 416mg, Trifolium pratense (Red Clover) ext equiv to dry leaf 337.2mg Lepidium meyenii (Maca) tuber powder 333mg Dioscorea oppositifolia (Chinese yam) ext equiv to dry root and rhizome 266.5mg Rubus idaues (Raspberry) ext equiv to dry root 150mg Taraxacum officinale (Dandelion) ext equiv to dry leaf 150mg Gymnema sylvesytre (Gymnema) ext equiv to dry leaf 111mg Glycyrrhiza Glabra (Liquorice) powder equiv to dry root and stolon 14.85mg Free from artificial sweeteners, flavours, colours and preservatives. Contains lactose and sugars. This powder will be put into maroon capsules whereby 4 capsules will equal 1 teaspoon of powder per day. The compliance strategy is via capsule return. At each follow up, the capsules remaining will be countered and checked with the participant diary. As this trial is via telehealth, the participants will be send the participant diary into the centre. Each follow up will be via zoom or teams and the participant must show the RA the container and count the number left during the follow up appointment.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
Females between 40 to 66 years of age More than 3 vasomotor symptoms (hot flushes) within a 24-hour period. BMI between 18-35 kg/m2 Normal liver and kidney function (within range of the pathology lab used) Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent
Exclusion criteria
Undiagnosed vaginal bleeding. Use of HRT in the previous three months before baseline Use of any herbal formula that affects hormonal levels in the previous three months before baseline History of alcohol or drug abuse and currently still drinks more than 2 standard glasses of alcohol daily or uses recreational drugs History of or current breast, endometrial or ovarian cancer. Ovariectomy or complete hysterectomy Uncontrolled and or untreated hypertension (defined as systolic blood pressure >160mm Hg and/ or diastolic blood pressure >100 mm Hg.) Uncontrolled psychiatric disorders. Uncontrolled and/or diagnosed medical conditions that may interfere with study medication e.g. Diabetes mellitus, hepatic or renal dysfunction.
Outcome results
None listed