“Effectiveness of Drakshavaleha in Improving the Symptoms of Functional Gastrointestinal Disorders(FGD) – A Multi-Centre Study”

Functional Gastrointestinal Disorders (FGIDs) are defined as several variable combinations of chronic or recurrent gastrointestinal (GI) symptoms that do not have an identified underlying pathophysiology and that occur without any underlying structural abnormalities. FGID may include several separate idiopathic disorders that affect different parts of the gastrointestinal tract. FGIDs are the most common problem in gastroenterological practice.1

Although FGIDs are not life-threatening, they can substantially affect quality of life (QOL). FGIDs hold significant public health relevance as they are highly prevalent, can disrupt daily functioning, and contribute to considerable social and economic burdens. Consequently, their overall impact on population health is likely to be substantial.2 Functional GI symptoms such as chronic recurrent bloating, heartburn, dyspepsia and constipation are also common in the geriatric population due to age-related physiological changes, reduced mobility, dietary habits and due to various other medications.3,4 Gastrointestinal (GI) disorders significantly affect health-related quality of life (HRQOL), with a more pronounced impact observed in individuals suffering from functional GI disorders than those with organic GI diseases. The decline in HRQOL is closely linked to the severity of both psychological and gastrointestinal symptoms.5 Comorbid physical and mental illness can have a significant impact on the aetiology, presentation and treatment of gastrointestinal syndromes.6

Drakshavaleha, a classical Ayurvedic formulation with Draksha (Vitis vinifera**)** as the main ingredient, is known for its Vata-alleviating properties and mild laxative action. Traditional evidence suggests its use promotes smooth bowel movements and relieves abdominal discomfort. Moreover, studies have shown its effectiveness in managing constipation in pregnant women, which indicates its gentle and safe action on the gastrointestinal tract.7 Amalaki/Amla (Emblica Officinalis P) fruit juice is the base to mix all the ingredients in this medicine, and is a well-known Rasayana medicine (having nourishing properties, especially for age-related degeneration).8 Pippali (Piper longum) and other ingredients in Drakshavaleha further support digestive functions and Agni (digestive fire), which can be particularly beneficial in aged individuals with impaired digestion.9

This study aims to assess the effectiveness of the trial medicine, Drakshavaleha, in patients with functional gastrointestinal disorders (FGID), which is chronic and is prevalent in 35% new cases referred to a GE in clinic as per a published study (Shivaji UN and Ford AC. 2014.)10. Assuming that complete remission of all symptoms as per the score of the Gastrointestinal Symptom Rating Scale (GSRS) may be observed in at least 5% cases of FGID after administration of Drakshavaleha with a relative margin of 15% at a 95% confidence interval, the sample size is 3250. Adding a possibility of a 20% dropout, the total sample size becomes 3900, which may be rounded up to 4500 to distribute the sample size to 15 study sites. Each study site shall recruit at least 300 study participants