Efficacy of Individualized Homoeopathic medicines or Bowel nosodes compared to placebo in irritable bowel syndrome: A three-armed, randomized, parallel group, placebo-controlled, double-blind, interventional trial.

Irritable bowel syndrome (IBS) is afunctional gastrointestinal disorder which is characterized by abdominal pain and abnormal defecationpatterns. The global prevalence isestimated between 10% and 20%.IBSis classified into four subtypes: IBSwith predominant constipation (IBS-C), IBS with predominant diarrhea (IBS-D),with mixed bowel habits (IBS-M) orIBS, unsubtyped. IBS manifests as acollection of gastrointestinal symptoms that change significantly from patientto patient and return on an episodic basis. Abdominal pain or abdominaldiscomfort with altered bowel habit is the predominant feature of IBS. There may be alternating diarrhea and constipation,and other associated symptomsinclude mainly gas bloating,which is temporarily relieved by defecation, upper gastrointestinal symptoms like dyspepsia,heartburn etc. Many patients with IBSsuffer from visceral hypersensitivity i.e. ‘feel their gut too much’, fromanxiety, depressed mood and various symptomsfrom many other regions of the body (a phenomenon called somatization).This condition is associated with impaired quality of life andlimitations in daily activities, withoutaffecting overall survival. The economic burden of the disease is substantialat the individual, healthcare system and societal levels. Severe IBScan significantly alter quality of life,      disrupt daily activities, and result in inflatedhealthcare costs. As IBS is merely a symptom-based conditionso it can be better managed or treated by homoeopathywhich is also based upon the principle of symptom similarities.Individualization is the process ofarriving at the image of the patient for the selection of remedy. The customary way of individualization of the patient is throughthe construction of totality of symptoms accordingto which Similimum is prescribed. Along with constitutional medicinesbased on individualization there isanother group of medicines that have been prepared and proven from the humangut flora named Bowel Nosodes. Since homeopathy’s effectiveness for irritablebowel syndrome has not yet been exhaustively investigated, more studies that adhere to the highestmethodological standards are required. In thisstudy we aim to assess the efficacy of individualized homoeopathic medicines orbowel nosodes compared to placebo with regard to disease-specific quality of life in patients with IBS. Alongwith it symptom severity of IBS, stool consistency and stool culture of patientswill be assessed. Dietary modifications will be given in all the three groups.