Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participant Selection
2.3. Study Intervention
2.4. Randomization Procedures
2.5. Pain Assessment
2.5.1. Categorical Pain Intensity (0–3) (at Screening)
2.5.2. Numerical Rating Scale for Pain (NRS) (0–10)
2.5.3. Categorical Pain Relief Scale (0–4) (PRS)
2.5.4. Global Evaluation Assessment
2.6. Study Outcome Measures
2.7. Evaluation of Safety
2.8. Study Procedure
2.8.1. Screening Phase Visit 1 (Day-21 to -1):
2.8.2. Treatment Phase
2.9. Statistical Analysis
3. Results
4. Discussion
Limitations and Future Direction of Study
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Parameters | Placebo | Treatment | ||||
---|---|---|---|---|---|---|
Mean | SD | SE | Mean | SD | SE | |
Age (years) | 26.40 | 4.55 | 0.83 | 26.67 | 4.26 | 0.78 |
Height (cm) | 156.31 | 5.17 | 0.94 | 155.30 | 4.34 | 0.79 |
Weight (kg) | 54.07 | 4.95 | 0.90 | 54.10 | 5.27 | 0.96 |
Duration of menstrual cycle (days) | 28.50 | 2.71 | 0.50 | 29.27 | 2.49 | 0.45 |
Variable | Count | Mean | SD | SE | 95% LCL (Mean) | 95% UCL (Mean) | p-Value |
---|---|---|---|---|---|---|---|
Placebo | 30 | 1.5 | 2.11 | 0.39 | 0.71 | 2.29 | p < 0.001 * |
Treatment | 30 | 18.9 | 3.08 | 0.56 | 17.75 | 20.05 |
Category (% Max TOTPAR) | Placebo | Treatment | Placebo (%) | Treatment (%) |
---|---|---|---|---|
<30 | 20 | 0 | 66.67 | 0 |
30–49 | 4 | 0 | 13.33 | 0 |
50–69 | 1 | 6 | 3.33 | 20 |
≥70 | 5 | 24 | 16.67 | 80 |
SPID (0–6 h) | Treatment (n = 30) | Placebo (n = 30) |
---|---|---|
Mean | 34.317 | 1.7 |
SD | 7.7454 | 3.0727 |
95% CI LCL (Mean) | 31.4245 | 0.5526 |
95% CI UCL (Mean) | 37.2088 | 2.8474 |
Mean Difference (Placebo treatment) | −32.6 | |
SE (Mean Diff) | 1.52132 | |
95% CI LCL (Mean Difference) | −35.66192 | |
95% CI UCL (Mean Difference) | −29.57141 | |
p 2-sided * | <0.0001 |
Time | Placebo | Treatment | LSM Difference (P-T) | * p-Value | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
LSM | SE (LSM) | 95% CI | p-Value | LSM | SE (LSM) | 95% CI | p-Value | |||||
LL | UL | LL | UL | |||||||||
0.5 | 0.2333 | 0.2079 | −0.1789 | 0.6455 | 1.0000 | 2.7 | 0.2079 | 2.2878 | 3.1122 | <0.0001 | −2.4667 | <0.0001 |
1 | 0.3333 | 0.2079 | −0.0789 | 0.7455 | 1.0000 | 3.7667 | 0.2079 | 3.3545 | 4.1789 | <0.0001 | −3.4333 | <0.0001 |
1.5 | 0.2333 | 0.2079 | −0.1789 | 0.6455 | 1.0000 | 4.6 | 0.2079 | 4.1878 | 5.0122 | <0.0001 | −4.3667 | <0.0001 |
0.2 | 0.2079 | −0.2122 | 0.6122 | 1.0000 | 5.2667 | 0.2079 | 4.8545 | 5.6789 | <0.0001 | −5.0667 | <0.0001 | |
2.5 | 0.2667 | 0.2079 | −0.1455 | 0.6789 | 1.0000 | 5.7667 | 0.2079 | 5.3545 | 6.1789 | <0.0001 | −5.5 | <0.0001 |
3 | 0.2 | 0.2079 | −0.2122 | 0.6122 | 1.0000 | 6.1667 | 0.2079 | 5.7545 | 6.5789 | <0.0001 | −5.9667 | <0.0001 |
3.5 | 0.3333 | 0.2079 | −0.0789 | 0.7455 | 1.0000 | 6.4667 | 0.2079 | 6.0545 | 6.8789 | <0.0001 | −6.1333 | <0.0001 |
4 | 0.3333 | 0.2079 | −0.0789 | 0.7455 | 1.0000 | 6.6333 | 0.2079 | 6.2211 | 7.0455 | <0.0001 | −6.3 | <0.0001 |
4.5 | 0.3333 | 0.2079 | −0.0789 | 0.7455 | 1.0000 | 6.7333 | 0.2079 | 6.3211 | 7.1455 | <0.0001 | −6.4 | <0.0001 |
5 | 0.3 | 0.2079 | −0.1122 | 0.7122 | 1.0000 | 6.7667 | 0.2079 | 6.3545 | 7.1789 | <0.0001 | −6.4667 | <0.0001 |
5.5 | 0.3667 | 0.2079 | −0.0455 | 0.7789 | 1.0000 | 6.8667 | 0.2079 | 6.4545 | 7.2789 | <0.0001 | −6.5 | <0.0001 |
6 | 0.2667 | 0.2079 | −0.1455 | 0.6789 | 1.0000 | 6.9 | 0.2079 | 6.4878 | 7.3122 | <0.0001 | −6.6333 | <0.0001 |
Category | Placebo | Treatment | Placebo (%) | Treatment (%) |
---|---|---|---|---|
<30 | 30 | 0 | 100 | 0 |
30–49 | 0 | 1 | 0 | 3.33 |
50–69 | 0 | 6 | 0 | 20 |
≥70 | 0 | 23 | 0 | 76.67 |
Poor (=0) | Fair (=1) | Good (=2) | Very Good (=3) | Excellent (=4) | Mean ± SD | Mean Difference ± SE | p-Value | |
---|---|---|---|---|---|---|---|---|
Treatment, n (%) | 0 | 0 | 0 | 8 (26.7%) | 22 (73.3%) | 3.73 ± 0.45 | −3.57 ± 0.11 | <0.0001 |
Placebo, n (%) | 25 (83.3%) | 5 (16.7%) | 0 | 0 | 0 | 0.17 ± 0.38 |
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Agarwal, D.; Chaudhary, P. Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study. J. Clin. Med. 2023, 12, 3968. https://doi.org/10.3390/jcm12123968
Agarwal D, Chaudhary P. Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study. Journal of Clinical Medicine. 2023; 12(12):3968. https://doi.org/10.3390/jcm12123968
Chicago/Turabian StyleAgarwal, Divya, and Priyanka Chaudhary. 2023. "Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study" Journal of Clinical Medicine 12, no. 12: 3968. https://doi.org/10.3390/jcm12123968
APA StyleAgarwal, D., & Chaudhary, P. (2023). Effect of Turmeric–Boswellia–Sesame Formulation in Menstrual Cramp Pain Associated with Primary Dysmenorrhea—A Double-Blind, Randomized, Placebo-Controlled Study. Journal of Clinical Medicine, 12(12), 3968. https://doi.org/10.3390/jcm12123968