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.

S. Suman, P. Karthikeyan, S. Moulishankar, G. S. Aathithiah, M. Vetriselvan, M. Arunothayam*, Niranjana Murali Mohan

ABSTRACT

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.

Keywords: Curcuma longa, Piper nigrum, Cocos nucifera, Inflammatory bowel disease, Gut microbiota, Colorectal cancer prevention, Nutraceutical formulation.