A PILOT CLINICAL STUDY ON THE EFFICACY OF AN HERBAL FORMULATION CONTAINING CURCUMA LONGA, PIPER NIGRUM, AND COCOS NUCIFERA IN SUPPORTING COLORECTAL HEALTH AND PREVENTING EARLY BOWEL ABNORMALITIES

Background: Chronic gastrointestinal (GI) inflammation, driven by pathways such as NF-κB and STAT3, plays a pivotal role in the pathogenesis of inflammatory bowel disease (IBD) and its progression to colorectal cancer (CRC). This study evaluated the therapeutic rationale and preliminary clinical outcomes of a novel nutraceutical formulation comprising Curcuma longa extract, Piper nigrum extract, and Cocos nucifera oil. Methods: The formulation was designed to target inflammation, oxidative stress, mucosal integrity, and gut microbiota balance through complementary mechanisms. A Phase I pilot study assessed tolerability and symptomatic improvements in patients with irritable bowel syndrome (IBS) and mild IBD. Results: Curcumin exhibited anti-inflammatory effects via NF-κB inhibition and COX-2 suppression, while piperine enhanced curcumin bioavailability and modulated TLR-4 signalling. Cocos nucifera oil provided mucosal protection and facilitated phytochemical absorption. In the pilot study, 70% of participants achieved complete resolution of major GI symptoms, with the remainder showing moderate or mild benefit. Rapid improvements were noted in abdominal pain, bowel irregularities, constipation, and bloating. Age-stratified analysis suggested faster pain relief in younger adults and greater bowel regularity improvements in older adults. No dropouts or adverse events occurred. Conclusions: Preliminary findings indicate that this multi-targeted nutraceutical is safe, well- tolerated, and potentially effective for symptom relief in functional and low-grade inflammatory GI disorders, with implications for CRC prevention. Larger randomized controlled trials with biomarker and microbiome analyses are warranted to validate efficacy, optimize dosing, and assess long-term benefits.