Safety and Efficacy of Moderately-High Dose Turmacin® (Turmerosaccharide >10% w/w) Supplementation on Joint Discomfort in Healthy Adults - A Pilot Proof-of-Concept Single Arm Study

Abstract

Turmeric is well-known for its analgesic, anti-inflammatory and anti-arthritic properties but 69.4% of the turmeric rhizome contains Turmerosaccharides whose clinical benefit is still unexplored. Turmacin®/NR-INF-02 is an aqueous extract of Turmeric containing Turmerosaccharides (>10%w/w) with negligible curcuminoids. Previous study with low dose Turmacin® confirmed its safety and efficacy in alleviating induced knee pain in healthy volunteers. Hence, this study aimed to assess the safety and explore the efficacy of moderately high dose Turmacin®. It was an open-label, single-arm interventional trial conducted from August 2018 – January 2019 in a tertiary care teaching hospital. Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, p = 0.016) and Day-7 (MD = 32s, p = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = −0.93, p = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. Similar to the previous study with low dose Turmacin®, there was a significant increase in pain threshold and decrease in the maximum pain score post intervention.

Keywords:

• Curcuma longa
• knee
• pain
• turmacin
• turmeric
• turmerosaccharides

Declarations

Authors contributions

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Disclosure statement

No potential conflict of interest was reported by the authors.

Ethics approval

The study was approved by the Institutional Ethics Committee of St. Johns Medical College Hospital, Bengaluru vide study reference number 09/2018.

Additional information

Funding

The study was sponsored and funded by Natural Remedies Pvt. Ltd. (Bengaluru). There is no specific grant number for this funding.

Notes on contributors

Jeffrey Pradeep Raj

Jeffrey Pradeep Raj, Assistant Professor, Department of Clinical Pharmacology, Seth GS Medical College and King Edward Memorial Hospital, Mumbai, does research in the disciplines of Clinical Pharmacology, Non-communicable diseases, Medical education & Bioethics. He has an experience of approximately 10 years in conducting randomized controlled trials.

Shreeraam Venkatachalam

Shreeraam Venkatachalam, after completing his post-graduation from St. Johns Medical College is currently practicing as a consultant Consultant Arthroscopy and Trauma Surgeon, in Kurinji Hospital, Salem, Tamil Nadu, India. He is an aspiring clinical researcher in the field of orthopaedics for the last 5 years.

Rajkumar S. Amaravati

Rajkumar S. Amaravati, Professor, Orthopaedics, St Johns Medical College, has a particular interest in Hip and Knee Arthroscopy as well as Joint Replacement Surgery. He has been involved in clinical research for approximately 2 decades and an expert in Sports Medicine.