Efficacy of high-dissolution turmeric-sesame formulation for pain relief in adult subjects with acute musculoskeletal pain compared to acetaminophen: A randomized controlled study.

Girish H Rudrappa, Pruthvi T Chakravarthi, Irin Rosanna Benny

Journal: Medicine 2020;99(28):e20373

PMID: 32664057

Plain Language Summary

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Acute muscle and joint pain is often managed with non-steroidal anti-inflammatory drugs such as acetaminophen. However, there may be some benefits of using natural treatments also. Curcumin, Boswellia serrata, and sesame oil are all natural products that have been previously shown to have anti-inflammatory and pain reducing effects. This randomised controlled trial aimed to determine the effects of a combination of these, as a product known as Rhuleave-K, compared to acetaminophen on muscle and joint pain. The results showed that both treatments were equally effective at reducing pain. However, individuals given curcumin, B. serrata, and sesame oil, were 8.57 times more likely to experience reduced unpleasantness and emotional aspects involved with acute pain. It was concluded that this Rhuleave-K is a natural, safe, and effective alternative to acetaminophen for the management of joint and muscle pain. This study could be used by healthcare professionals to understand that there is an alternative for those who are unable to tolerate or who would like a more natural alternative for the management of joint and muscle pain.

Expert Review

Reviewer: Chloe Steele
14th Apr 2025
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Conflict of interest

None

Take home message

  • Pharmacological treatments may not be the only option for MSK pain relief.
  • If a natural alternative is preferred or pharmacological treatments are contraindicated then a combination of curcumin, B. serrata, and sesame oil in the form of Rhuleave-K (1000mg/day) may help to relieve pain.

Evidence category

A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)

Summary review

Introduction

  • Acute musculoskeletal (MSK) pain occurs within the muscles, ligaments, joints, and tendons and is mostly managed with non-steroidal anti-inflammatory drugs such as acetaminophen.
  • There may be some benefits to MSK pain when using non-pharmacological treatments.
  • Curcumin, Boswellia serrata, and sesame oil have been shown to have anti-inflammatory and analgesic effects yet it is unclear as to their efficacy when combined on MSK pain.
  • This randomised control trial aimed to determine the effects of a combination of these compared to acetaminophen.

Methods

  • This was a randomised active controlled open label study.
  • The study included 88 male and female individuals aged 18-65 years.
  • Participants were randomised to either 1000 mg/d curcumin, B. serrata, and sesame oil (Rhuleave-K) or 1000 mg/d acetaminophen.
  • The study ran for 7 days.

Results

  • Both treatments were equally efficacious on the reduction of pain (meaningful pain relief P =0.228, and perceptible pain relief; P =0.793).
  • Pain relief was seen in both groups from baseline with no differences between the two groups through the assessment of the total pain relief scale (TOTPAR P=0.529 after 7 days), the pain relief score (PRS; P=0.748 after 7 days), and the McGill Pain Relief Questionnaire (P=0.468).
  • Both groups provided sensory pain relief but the curcumin group was 8.57 times better than acetaminophen at reducing the unpleasantness and emotional aspects involved with acute pain (P=0.027).

Conclusion

It was concluded that Rhuleave-K is a natural, safe, and effective alternative to acetaminophen for MSK pain.

Clinical practice applications

  • The clinical effects on MSK pain of curcumin, B. serrata, and sesame oil combination may be equivalent to acetaminophen.
  • For relief of the unpleasantness associated with pain, this natural alternative may be more effective than acetaminophen.
  • Practitioners may like to consider recommending a combination of curcumin, B. serrata, and sesame oil for the relief of MSK pain symptoms in those who would like a natural alternative or who are contraindicated to acetaminophen.

Considerations for future research

  • Future research may like to consider looking at other causes and sites of pain to determine if this natural combination may be of benefit.
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Abstract

BACKGROUND

Acetaminophen (paracetamol) is one of the most commonly used over-the-counter for pain relief. Management of acute pain with plant-based nutrients has remained suboptimal due to an absence of data supporting acute relief of pain. In the present study, it was hypothesized that high-dissolution liquid treatment of black sesame extract oil, Curcuma longa and Boswellia serrata may provide pain relief in people with acute musculoskeletal pain as quickly as acetaminophen.

METHODS

In this randomized active controlled open label study, 88 healthy subjects with acute musculoskeletal pain were randomized to receive treatment capsule (Rhuleave-K; 1,000 mg/d) or 1,000 mg/d acetaminophen for 7 days. Change in pain intensity and pain relief at first 6 hours, 3 days, and 7 days were measured. The onset of analgesia was measured by perceptible pain relief and meaningful pain relief. Other measures were McGill Pain Questionnaire and Patient Global Impression Change.

RESULTS

The treatment formulation resulted in average magnitude of pain relief comparable to the acetaminophen. Sixty-six percent of subjects in the treatment group reported positive response in pain relief (≥50% max TOTPAR; total pain relief) after 6 hours, compared to 73% of control. Seventy-three percent of subjects on treatment were considered positive responders, compared to 80% in the control group. The average time of onset of analgesia was 1 hour for the treatment group, versus 0.83 hour for control. At the end of day 3 and 7, there was significant improvement (P < .001 for day 3 and day 7) in the pain condition of treatment group and was comparable to control (P = .436 for day 3 and P = .529 for day 7). The total McGill Pain score showed significant reduction in pain with the treatment irrespective of the pain intensity statistically equal (P = .468) to control. Both the groups were equal in providing sensory pain relief (P = .942), but the treatment was 8.57 times significantly better (P = .027) than acetaminophen in reducing the unpleasantness and emotional aspects (affective domain) involved with acute pain.

CONCLUSION

The results showed that the treatment used in the study may act as a natural, fast acting, and safe alternative for acute pain relief comparable to acetaminophen.

Address: Department of Orthopedics, Sapthagiri Institute of Medical Sciences and Research Center, Bangalore, Karnataka.; Amala Institute of Medical Sciences, Amala Nagar, Thrissur, Kerala, India.

Patient Centred Factor

Modifiable Lifestyle Factors

Jadad Score

Allocation Concealment

Bioactive Substances

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