Efficacy of individualized homoeopathic medicines in the management of chronic insomnia in adults: Double-blind, randomized, placebo-controlled trial

Insomnia is defined by the presence of an individual’s report of difficulty with sleep. Chronic insomnia is a frequent and persistent difficulty of initiating or maintaining sleep that occurs despite adequate opportunity and circumstances for sleep and that results in general sleep dissatisfaction and some form of daytime impairment. Daytime symptoms typically include fatigue, depressed mood or irritability, general malaise and cognitive impairment. The sleep disturbances and associated with symptoms occurs at least several times per week for at least 3 months. Absence of daytime symptoms are not considered as chronic insomnia. The Diagnostic and statistical Manual of Mental Disorders, 5th edition and ICSD-3, which have similar criteria for making the diagnosis. These criteria specify that symptoms must cause clinically significant functional distress or impairment be present for at least 3 nights/week for at least 3 months and not linked to other sleep, medical or mental disorders. In homoeopathy 4 randomized controlled trials done in which compared homoeopathic medicines to placebo. All involved small number of patients and were low methodological quality. None demonstrated a statistically significant difference in outcomes between groups, although two showed a trend favouring homoeopathic medicines and 3 demonstrated significant improvement from baseline in both groups. Existing RCTs were of poor quality and were likely to have been underpower. So there is need to undertake a trial to assess whether IHMs could produce any significant effect differ than placebo in adults suffering from chronic insomnia. Primary outcome measure will be used in this trial PSQI and Secondary outcome measures will be ISI and Daily Sleep Diary with Master Chart Calculator. All the outcome measures will be assessed at baseline, every month up to 3 months of follow up. Group differences will be measured statistically. Results will be published in a scientific journal.