ABSTRACT:
Background: Polycystic ovarian syndrome (PCOS) is an emerging health problem in
young females characterized by ovarian dysfunction and hyperandrogenism. Existing
information indicates a positive role of homoeopathy but more rigorous studies are
desirable. This protocol has been developed to undertake a pilot study to evaluate the
efficacy of homoeopathic intervention using established diagnostic criteria.
Methods/Design: It will be a multi‑centric, randomized, placebo controlled pilot study
with a 6‑month intervention and follow up period. Minimum 60 cases fulfilling the
eligibility criteria will be enrolled and randomized to receive either the homoeopathic
intervention or the identical placebo. Both the arms follow lifestyle modification for
weight reduction. Primary endpoint will be the establishment of regular menstrual
cycle along with improvement in either ultrasonology or hirsutism/acne. Secondary
endpoints will be to compare the changes in total and individual domain scores of
PCOS questionnaire at monthly interval and the changes in ultrasound of polycystic
ovaries. For the primary outcome and each of the secondary outcomes, both per
protocol and modified intention to treat analysis will be done.
Discussion: This pilot study has been planned considering the varied presentation of
PCOS as per international diagnostic criteria and accordingly the composite endpoints
have been kept for evaluation. The outcome of this pilot study will help in planning a
definite study.
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