An open-label, randomized, placebo-controlled trial to evaluate the efficacy of Passiflora incarnata and individualized homeopathic medicines in insomnia

Insomnia is a prevalent condition associated with impaired day-time functioning, reduced quality of life, increased risk of morbidity and substantial societal cost. Numerous pharmacological and non-pharmacological therapeutic options exist. However, these treatments are not always fully effective and some have marked adverse effects. Because of this, many patients suffering from insomnia may try alternative therapies such as homeopathy. A systematic review was conducted to evaluate all randomized trials investigating the effectiveness of homeopathy for insomnia and sleep-related disorders. It concluded that the evidence from randomized trials does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. Subsequently, in a recent double blind, randomized, prospective, placebo-controlled, two parallel arms clinical trial on 60 patients suffering from insomnia at National Institute of Homoeopathy (NIH) produced significantly better effect than placebo. Thus in face of conflicting evidences and in order to explore the issues further, we aimed to evaluate the efficacy of Passiflora incarnata and individualized homeopathic medicines (IH) in comparison with placebo in 60 patients suffering from insomnia. The enrolled patients will be randomized in 1:1:1 ratio to either of the interventions – Passiflora incarnata (n=20), IH (n=20) or placebo (n=20). Sleep efficiency score of daily sleep diary will be the primary outcome, measured at baseline and every month up to 3 months. Rest of the sleep diary items and Insomnia Severity Index (ISI) will be the secondary outcomes, measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.