ASP 2022 Research

Crinum latifolium cultivation, harvesting and research process

American Society of Pharmacognosy 2022

Crila Herbal Supplement Reduces Lower Urinary Tract Symptoms in Latino Men

Bernard W. Somers¹, Betsy Singh², Laura J. Camacho Choza³, Pablo F. Gonzalez Limon³, Francisco Gomez Regalado³, Mark Scholz⁴, Nadina Jose⁵

¹Department of Medicinal Chemistry, Rutgers University New Brunswick, NJ; ²BRCG Medical Research Group, Midlothian, VA; ³PanAmerican Clinical Research Group, Mexico; ⁴Prostate Oncology Specialists, California; Medical Director, Prostate Cancer Research Institute of Los Angeles, California; ⁵Department of Health Informatics, Rutgers University Newark, NJ

Abstract

Lower urinary tract symptoms (LUTS) are commonly experienced by men as they age, affecting 56% of men ages 50–79 and 70% of men ages 80–89.

A prospective, open-label dietary supplement clinical study evaluated oral Crila herbal supplement (Crinum latifolium L. var. crilae Tram & Khanh) in 49 men with LUTS over 90 days in Guadalajara and Querétaro, Mexico.

Eighty-eight percent of participants showed improvement in LUTS after study completion, with significant improvement observed from baseline to subsequent visits.

Background

Lower urinary tract symptoms are commonly experienced by men as they age. Over-the-counter plant extracts such as saw palmetto (Serenoa repens) have been used in attempts to address LUTS, although studies examining the efficacy of these extracts have produced inconclusive results.

The genus Crinum, including Crinum latifolium, has a history of traditional medicinal use in Asia and other parts of the world.

In a previous clinical study involving 189 men, 157 completed the study and 89.2% showed a beneficial response on the American Urological Association Symptom Score Survey.

Methods

This was a two-center, prospective, open-label study involving men with lower urinary tract symptoms who received C. latifolium extract (Crila) for three months.

The study was conducted at two university-affiliated centers in Mexico. Its primary endpoint evaluated the impact of oral Crila capsules on LUTS using the AUA Symptom Score Survey.

Forty-nine subjects completed the study. Participant assessments were performed from screening through the final Day 90 visit.

Table 1 showing the 90-day study schedule — Table 1. Study Schedule Over 90 Days

Figure 1 American Urological Association symptom score survey — Figure 1. AUA Symptom Score Survey

Table 2 showing dosing and administration — Table 2. Dosing and Administration

Inclusion Criteria

Male subjects over 40 years of age
BMI below 30
AUA Symptom Score greater than 10
Able and willing to return to the clinic for study procedures
Able and willing to provide informed consent

Exclusion Criteria

Exclusion criteria included BMI greater than 30, AUA Symptom Score below 10, certain previous medical conditions, specified concurrent medications and supplements, uncontrolled diabetes, alcohol or substance abuse that could interfere with study adherence, and participation in certain recent experimental clinical studies.

Results

Mean total AUA Symptom Score values were evaluated across four study visits for the 49 participants who completed the study.

Compared with the baseline visit, subsequent visits had significantly lower total AUA scores, suggesting continued improvement in LUTS over the study period.

Twenty-eight of the 49 participants, or 57%, completed the study within the “Mild” symptom score range.

Table 3 mean total AUA symptom scores — Table 3. Mean Total Scores on AUA Symptom Score Survey

Table 4 AUA symptom score intervisit results — Table 4. AUA Symptom Score Survey Intervisit Results

Table 5 AUA symptom score index — Table 5. AUA Symptom Score Index

Figure 2 AUA symptom score survey results — Figure 2. AUA Symptom Score Survey Results

Figure 3 AUA symptom score index results — Figure 3. AUA Symptom Score Index Results

Figure 4 AUA symptom score index sub-score analysis — Figure 4. AUA Symptom Score Index Sub-score Analysis

Conclusion

The study reported improvement in lower urinary tract symptom scores during the 90-day Crila regimen. The researchers noted that symptom scores continued to decrease over the course of the study.

The authors recommended a longer-duration study of six to twelve months to determine whether improvement continues over a longer treatment period and whether a symptom plateau occurs.

References

Maserejian, Nancy N., et al. “Incidence of lower urinary tract symptoms in a population-based study of men and women.” Urology 82.3 (2013): 560–564.
Parsons, J. Kellogg. “Benign prostatic hyperplasia and male lower urinary tract symptoms: epidemiology and risk factors.” Current Bladder Dysfunction Reports 5.4 (2010): 212–218.
Kim, Tae-Hun, et al. “Dietary supplements for benign prostatic hyperplasia: An overview of systematic reviews.” Maturitas 73.3 (2012): 180–185.
Boyle, P., et al. “Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia.” BJU International 93.6 (2004): 751–756.
Ellem, Stuart J., and Gail P. Risbridger. “The dual, opposing roles of estrogen in the prostate.” Annals of the New York Academy of Sciences 1155.1 (2009): 174–186.

Acknowledgements

Crila Health
EPIC CRO
CliniOps Inc.
BRCG Medical Research
PanAmerican Clinical Research
Rutgers, The State University of New Jersey

This research was supported by Crila Health Pte. Ltd. and, in part, by a directed donation from the Avis LaGrone Charitable Fund.

For Further Information

Bernard W. Somers: bernard.somers@rutgers.edu

Nadina Jose MD: ncj26@rutgers.edu

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