None listed
Conditions
Brief summary
This is a descriptive study of a group of 15 women to comment on the possibility of an association between changes in menopausal symptoms following the use of a complementary therapy. Participants will have good general health and demonstrate a recorded minimum of 21 hot flushes per week and above 80% compliance during placebo run in. They will self administer 2 placebo tablets twice daily over the 28 day run in period and two tablets of Zen Harmony twice daily over 12 weeks of active treatment. Participants will be supplied with a daily diary containing a record of vasomotor symptoms (flushing) and instructed how to complete the required data. They will also complete the Greene Climacteric Scale, the Women's Health questionnaire and the Menopause rating scale at each clinic visit. .
Interventions
Chinese and western herbal medicine including
Rehmannia glutinosa root, 1.2g,
Angelica polymorpha root, 200mg,
Dioscorea opposita root rhiz, 200mg,
Paeonia lactiflora root, 200mg,
Bupleurum falcatum root, 200mg,
Vitex agnus-castus fruit, 100mg,
Calcium hydrogen phosphate, 350mg,
Calcium amino acid chelate, 50mg,
Magnesium amino acid chelate, 50mg,
Cholecalciferol (Vitamin D3 100IU), 2.5mcg, taken orally twice a day for 12 weeks of treatment. Every particpant will take a placebo for 4 weeks and t
Chinese and western herbal medicine including Rehmannia glutinosa root, 1.2g, Angelica polymorpha root, 200mg, Dioscorea opposita root rhiz, 200mg, Paeonia lactiflora root, 200mg, Bupleurum falcatum root, 200mg, Vitex agnus-castus fruit, 100mg, Calcium hydrogen phosphate, 350mg, Calcium amino acid chelate, 50mg, Magnesium amino acid chelate, 50mg, Cholecalciferol (Vitamin D3 100IU), 2.5mcg, taken orally twice a day for 12 weeks of treatment. Every particpant will take a placebo for 4 weeks and then the active treatment for 12 weeks, twice daily.Placebo comprised of the same excipent base as the active treatment. The particpants will take two tablets twice daily with warm water 15 minutes before food for 4 weeks. The tablets will be taken orally. Past researchers have found a noticeable placebo effect on menopausal symptoms. The literature indicates that the most effective method to avoid this anomaly is to utilise a methodology similar to that which this trial proposes
Sponsors
Martin & Pleasance
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Females aged between 45 and 65 years A recorded minimum of 21 hot flushes per week during placebo run in. Amenorrhea between 2 and 6 consecutive months duration in the year prior to entry In good general health Adequate venous access
Exclusion criteria
Follicle stimulating hormone levels less than 30mIU/ml Individuals who have had a hysterectomy Individuals who are vegetarian Individual consumes soy products more then once a week Individuals taking antibiotics or antacids Individuals taking hormone preparations three months prior to enrolment Individuals with disorders of the gastro intestinal tract Individuals with atrial fibrillation Individuals with bleeding disorders Individuals taking anticoagulant medication Individuals who consume more than 1 cup of coffee per day Individuals with cholecystitis and/or gallstones Individuals taking diuretic medications Individuals who consume more than 1 alcoholic drink per day Individuals with a known allergy to the herbal medications Individuals with serum urea, electrolytes and creatinine greater than 2 times the upper limit of normal at baseline Liver function tests greater than 3 times the upper limit of normal at baseline Individuals unwilling to cease current herbal, vitamin and mineral supplements Participants who have participated in another clinical trial in the last 30 days Participants unwilling to comply with the study protocol Any other condition, which in the opinion of the investigators could compromise the study
Outcome results
None listed