• Pioneer Wellness Clinics

Homoeopathy in polycystic ovarian syndrome: A randomized placebo‑controlled pilot study


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.


Source : https://www.researchgate.net/publication/273756094_Research_Protocol_Homoeopathy_in_polycystic_ovarian_syndrome_A_randomized_placebo-controlled_pilot_study



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