Role of individualised homoeopathic medicine in the management of insomnia in post menopausal women an open label single arm prospective clinical study

This prospective, open label, single arm, clinical study will be conducted over 18 month at the National Institute of Homoeopathy, Kolkata, with each patient followed for six months. The study aim to evaluate the role of individualised Homoeopathic Medicine in the management of insomnia in post menopausal women. The primary objective is to determine the role of individualized homoeopathic medicine in the patients of insomnia in post- menopausal women by evaluating change in Women’s Health Initiative Insomnia rating scale after 6 months of treatment. The secondary objective is to evaluate change in Menopausal Rating Scale using individualized homeopathic medicine in insomnia in post-menopausal women associated after 6 months of treatment. A Women aged 45-60 years experiencing natural menopause, from all religion and socio- economic background. Insomnia accompanied by menopausal symptoms like hot flashes, night sweats, mood disturbance or hormonal imbalance. Patients suffering from chronic insomnia (difficulty initiating or maintaining sleep) for more than 3 months. Patients with ability to read /write /understand Hindi or English or Bengali. Patients who are willing to participate in the study and giving informed written consent will be included. Women with insomnia cause by underlying medical condition such as thyroid disorder, other serious chronic illness. Patients on hormone replacement therapy (HRT)or other conventional medication specifically for insomnia. Women with a history of severe psychiatric disorder such as major depression or bipolar disorder. Patients not willing to take part in the study and not ready to give the written consents for the same. Women undergoing induced menopause due to surgery will be excluded.Individualized homeopathic remedies will be selected based on repertorization (Synthesis Repertory) and Materia Medica, following Hahnemannian principles, with monthly follow-ups for six months to assess symptom changes. Treatment efficacy will be determined by comparing pre- and post-treatment of women’s health Initiative insomnia rating scale and menopausal rating scale.