Effect of Turmeric-Boswellia-Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea-A Double-Blind, Randomized, Placebo-Controlled Study.

Abstract

Primary dysmenorrhea is a common menstrual disorder that significantly impacts women's quality of life, productivity, and healthcare utilization. In this randomized, double-blinded, placebo-controlled trial, sixty women with primary dysmenorrhea were randomly divided into two groups with thirty participants each, and were allocated either turmeric-boswellia-sesame formulation (treatment) or placebo. The participants were advised to take two softgels of 500 mg as a single dose of allocated study intervention (total dose 1000 mg) when their menstrual pain reached 5 or more on a numerical rating scale (NRS). Menstrual cramp pain intensity and relief were evaluated every 30 min post-dose until 6 h. Results indicated a promising role of turmeric-boswellia-sesame formulation for menstrual pain relief compared to the placebo. The mean total pain relief (TOTPAR) of the treatment group (18.9 ± 0.56) was found to be 12.6 times better than the placebo group (1.5 ± 0.39). The NRS analysis showed that there was a statistically significant difference in pain intensity between the treatment and placebo groups (p < 0.001) at every timepoint. Additionally, the sum of pain intensity difference at 6 h (SPID6) of the treatment group (34.32 ± 1.41) showed a significant difference (p < 0.0001) and was 20.19 times better when compared to placebo (1.7 ± 0.56). Based on the study results, the turmeric-boswellia-sesame formulation exhibited remarkable menstrual pain relief as compared to the placebo.