The addition of naturopathic herbal medicine to a lifestyle intervention for women with polycystic ovary syndrome (PCOS), a randomised controlled trial.

Phase 1

Completed

• Conditions: Polycystic ovary syndrome (PCOS).; Oligomenorrhoea.; Hormone health.; Anthropometric features.; Quality of life.; Engagement and adherence.; Alternative and Complementary Medicine - Herbal remedies; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12612000122853
• Lead Sponsor: Douglas Hanly Moir

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

Women aged between 18 and 44 years, with a diagnosis of PCOS according to the European Society of Hormone and Reproductive Endocrinology (ESHRE) diagnostic criteria detailed at Rotterdam in 2004. Women with a body mass index (BMI) greater that 25 kg/m2.
A basic level of literacy.
Availability for about 30 minutes to complete questionairres at the beginning and at the conclusion of the trial.
The physical ability and time availability to exerercise three times per week for 40-60 minutes.
Willingness to attend a pathology clinic and to provide a specimen of blood for analysis.
Ability to swallow 3-4 tablets per day.
Time to attend a naturopathic consultation for 30 minutes every 4 weeks for 12 weeks.

Exclusion Criteria

Women with PCOS and a BMI of 24 or less.
Women with conditions characterised by similar reproductive symptoms to PCOS.

English language familiarity. The outcome measures require participants with the ability to write and understand English to provide written consent and complete questionnaires.
The research focuses on improving menstrual regularity for women with PCOS and excludes women who are pregnant.
Children and young people have been excluded due to the infrequent diagnosis of PCOS in children and young people.
The pre-exercise screening required for entry onto the trial would exclude people highly dependant on medical care from being recruited into the trial due to the need for participation in regular exercise.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to menstruation (reduced oligomenorrhoea).[At the commencement of the trial and at 12 weeks.]