Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
Comparison of two CHM interventions, involving a combination of Chinese medicinal herbs in powdered form, routinely prescribed in the UK for symptoms of PCOS and manufactured according to Good Manufac
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females aged 18-44 2. Present with oligomenorrhoea (irregular periods) defined as intervals between periods of >35 days and <200 days, OR with amenorrhoea (absence of periods), defined as intervals between periods of =200 days 3. Diagnosis of PCOS consistent with the Rotterdam criteria
Exclusion criteria
Exclusion criteria: 1. Suffer from other causes of hyperandorgenism and menstrual irregularities e.g. thyroid or prolactin disorders, acromegaly, Cushing's syndrome 2. Are pregnant, or suspected to be pregnant 3. Are breastfeeding within 6 months of study start date 4. Are receiving treatments or medications prohibited for use during the study 5. History of liver or kidney pathologies 6. History of psychotic illness 7. Present with current and major depression 8. Current harmful and hazardous drinking 9. Allergies to herbal ingredients contained in the CHM treatments 10. Do not have the spoken or written language skills to take part owing to study assessments and materials being available only in English 11. Present with abnormal liver and/or kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To answer the primary feasibility question: 1. Menstrual frequency and variability of cycle length using menstrual diary data 2. Percentage of missing menstrual diary data 3. Measure Yourself Medical Outcome Profile (MYMOP) | — |
Secondary
| Measure | Time frame |
|---|---|
| To address the secondary feasibility questions: 1. Treatment effects at 6 months in proposed main-study secondary outcome measures of weight, BMI, waist-hip ratio, hirsutism, Polycystic Ovary Syndrome Questionnaire (PCOSQ), Dermatology Life Quality Index (DLQI), MYMOP 2. Treatment safety: liver and kidney function tests and the frequency, severity and nature of adverse events 3. Treatment adherence: weighing of herbal medicines and self-reported using Morisky Medication Adherence Scale (MMAS) 4. Eligibility and consent rate 5. Retention rate and reasons for loss to follow-up 6. Security of practitioner blinding by Bang Blinding Index 7. Adherence to study protocol by measuring compulsory and non-compulsory study follow-up rates 8. End-of-study feedback questionnaire | — |
Countries
United Kingdom
Outcome results
None listed