A single arm clinical study to evaluate the efficacy of kalyanaka guda in the management of irritable bowel syndrome with special reference to vatika grahani

INTRODUCTION:-

Ayurveda the traditional medical practice is playing an inevitable role in maintenance of health and disease prevention despite the era of modern medicine. Grahani dosha described in classical text books of Ayurveda represents a group of disorders of digestive system caused by impairment of Agni. Grahani dosha is such a disorder, wherein its significance is emphasized by its inclusion among Astha Mahagada. Grahani is located above Nabhi (umbilical region) and it is the Adhisthana (seat) of Agni. It is supported and nourished by the strength of Agni. Normally, it receives the ingested food, which is retained by it by restraining the downward movement (Grahanati). After digestion it releases the food through sides of lumen to next Ashaya i.e. Pakvashaya. In abnormal conditions due to weakness of Agni, it gets vitiated and releases food in undigested form.

In ayurvedic literature, Grahani is one of the symptom of saman avrit apan vayu. Therefore Irritable bowel syndrome can be considered as a disorder where there is dearrangement of vata in gastrointestinal tract specially of saman vayu and apan vayu leading to symptoms of pain in abdomen and altered bowel habit. Irritable Bowel Syndrome is a functional bowel disorder characterized by abdominal pain or discomfort and altered bowel habits in the absence of detectable structural deformities. Irritable bowel syndrome symptoms tend to come and go over time and often overlap with other functional disorder such as fibromyalgia, headache, backache, and genitourinary symptoms.

The pathogenesis of Irritable bowel syndrome is poorly understood, although roles of abnormal gut motor and sensory activity, central neural dysfunction, psychological disturbances, mucosal inflammation, stress and luminal factors have been proposed. On the basis of clinical symptoms of Irritable bowel syndrome we can correlate it with Vatika Grahani in Ayurveda.

The symptoms(gastrointestinal) present in Vatika Grahani are chirat mala pravrutti(Pass with difficulty after long time), drav(Liquid),shushkam(Dried), tanu(Thin)  aam(Undigested),phenam (Pass with froth),punah punah srujet vrchah(Frequency of stool) etc. No clear diagnostic markers exist for Irritable bowel syndrome thus the diagnosis of the disorder is based on clinical presentation. Spasmolytics, bulking and psychotropic agents are the main conventional pharmacological agents used in the Irritable bowel syndrome management.

AIM: -

To assess the effect of Kalyanaka Guda in the management of Irritable Bowel Syndrome with special reference to Vatika Grahani.

OBJECTIVES: -

Primary objectives: Evaluation of effect of Kalyanaka Guda on the intensity of abdominal pain and altered bowel habits.

Secondary objectives:  Evaluation of effect of Kalyanaka Guda on the other symptoms (Bloating and weakness) of IBS with special reference to Vatika Grahani and quality of life ( short form survey -36)

HYPOTHESIS: -

NULL HYPOTHESIS(H0):- There is no difference between baseline and after treatment in the intensity of symptoms and quality of life in the patients of IBS with special reference to Vatika Grahani.

ALTERNATIVE HYPOTHESIS(H1):- There is a difference between baseline and after treatment in the intensity of symptoms and quality of life in the patients of IBS with special reference to Vatika Grahani.

Study Design:-

Phase -2

• Study type-Single center, interventional, single arm, open label

• Population-The study will be conducted on clinically diagnosed patients ‘Vatika Grahani’ and Irritable Bowel Syndrome(ROME IV criteria) selected from OPD & IPD of Department of Kayachikitsa, NIA and SSBH, Hospital Jaipur.

• Sample- 30 patients

• Purpose- To assess the efficacy of the trial drug

• Masking- Open label

• Timing- Prospective

• Endpoint- Efficacy and safety

• No. of groups- One

• Duration- 28 days(4 weeks)