None listed
Conditions
Brief summary
The aim of this study is to evaluate the safety and efficacy of two herbal formulations in reducing menopausal symptoms in otherwise healthy women. Participants will be enrolled in the study between September 2014 and October 2015 and provided treatment for 3 months. All participants are provided with the treatment pack – which includes the product (active intervention 1, active intervention 2 or placebo), a daily symptom diary and a pre-prepared QML pathology form for safety profiling and hormone assessment. Participants take the medication daily and complete the symptom diary daily for 1 week/month. At month 1 and month 2, a telephone interview is conducted to confirm compliance and complete the QOL questionnaires. At month 3, participants repeat the blood test at a QML collection centre and they return to the clinic for final assessment. There will be regular communication with all participants during the study. There will be supervision of the trial by a qualified Medical Practitioner / Endocrinologist, A/Prof Warrick Inder who will monitor any adverse events associated with the trial.
Interventions
1. The Active intervention 1 is a 0 size blue-green hard gelatin capsules containing Tinospora Cardifolia 75mg, Asparagus racemosus 100mg, Withania somnifera 100mg, Commiphora mukul 225mg. (1 capsule, taken twice daily for 3 months)
2. The Active intervention 2 is a 0 size blue-green hard gelatin capsule containing 300mg of a standardised extract of Trigonella foenum graecum (Fenugreek) seed extract and 30mg of the flow agent maltodextrin. (1 capsule, taken twice daily for 3 months)
Compliance
1. The Active intervention 1 is a 0 size blue-green hard gelatin capsules containing Tinospora Cardifolia 75mg, Asparagus racemosus 100mg, Withania somnifera 100mg, Commiphora mukul 225mg. (1 capsule, taken twice daily for 3 months) 2. The Active intervention 2 is a 0 size blue-green hard gelatin capsule containing 300mg of a standardised extract of Trigonella foenum graecum (Fenugreek) seed extract and 30mg of the flow agent maltodextrin. (1 capsule, taken twice daily for 3 months) Compliance is measured by regular follow up (telephone, text and email) and the return of trial bottles (with any unused product) at completion of the trial.
Sponsors
Integrated Health Group Pry. Ltd.
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
Heterosexual females aged between 40 and 65 years Experiencing menopausal symptoms Otherwise healthy Written informed consent provided
Exclusion criteria
Women that have been using hormone replacement or herbal medicines for menopausal symptoms for at least 1 month prior to trial. Women with a previous history, presence, or suspicion of estrogen-dependent neoplasia, neoplastic disease or treatment for any neoplastic disease within the previous 2 years. Women that have had a partial or total hysterectomy. Women that have active or a recent history (in the last 6 months) of thromboembolic disease. Women that have a history of cerebrovascular accident, stroke, or transient ischemia. Women that have major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy. Women that have a known or suspected hypersensitivity to any of the herbal ingredients present in the investigational product. Women that are taking medication for diabetes, high cholesterol, hypertension, osteoporosis and osteoarthritis, administering laxatives or have digestive disease(s). Women that are currently using other investigational product(s). Women that have experienced unintended weight loss of more than 15% of body weight in last six months. Women with active substance abuse (alcohol or drug dependency).
Outcome results
None listed