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Abstract
LN18178 is a proprietary herbal blend containing extracts of Punica granatum fruit rind and Theobroma cocoa seeds. The objective of the present study was to evaluate the effect of LN18178 on serum testosterone levels in healthy young adults in a randomized, double-blind, placebo-controlled study. One hundred and twenty male volunteers (age 21-35 years) were randomized into three groups. Each group (n = 40) received a daily dose of either placebo or 200 or 400 mg LN18178 for fifty-six days. An increase in serum testosterone (free and total) was the primary efficacy measure of the study. The secondary measures included dihydrotestosterone (DHT), cortisol, Luteinizing hormone (LH), 17β-Estradiol (E2), hand grip strength, and the mid-upper arm circumferences (MUAC). The vital signs and clinical chemistry parameters in blood and urine were performed to determine product safety. Post-intervention, both doses of LN18178 significantly increased free testosterone (p < 0.0001 vs. baseline; p = 0.0268 and p < 0.0001, respectively vs. placebo). The high dose group showed significant increases in total testosterone (p < 0.0001 vs. baseline; p = 0.0184 vs. placebo) and luteinizing hormone (p < 0.0007 vs. baseline; p = 0.0470 vs. placebo). The changes in other hormones were not significant. At post-trial, the LN18178-400 group showed significant improvements in the hand grip strength and mid-upper arm circumference. The hemato-biochemical parameters, urinalysis, and vital signs of the participants were within the normal range. Together, these observations suggest that LN18178 is a safe and tolerable herbal blend; it increases testosterone level and increases muscle strength and MUAC in young, healthy males.
Supplemental data for this article is available online at https://doi.org/10.1080/19390211.2022.2035037 .
Acknowledgements
The authors thank Laila Group of Industries, Vijayawada, India, for financial support to conduct the study. The authors also thank B10 Analytics Pvt. Ltd, Thiruvananthapuram, Kerala, India, for the data analyses.
Authors’ contributions
SHVC conceived and designed the study. PGAS, AY, and MRK collected data. SHVC and JCM analyzed and interpreted the data. PGAS and AY drafted the manuscript. JCM critically reviewed the draft and finalized the manuscript. All authors have read and agreed to the submitted version of the manuscript.
Disclosure statement
The authors declare no conflict of interest for the present study and publication of this manuscript.
Additional information
Funding
Notes on contributors
Poorna Gopal Azad Sreeramaneni
Poorna Gopal Azad Sreeramaneni, MD, is a medical practitioner and a board-certified endocrinologist at Anu hospitals and Sreeramaneni Sumanth Krishna Hospitals, Vijaywada, Andhra Pradesh, India. His clinical research interests have been in endocrine disorders and obesity. Dr. Sreeramaneni has expertise in various endocrine diseases, especially in male hypogonadism. He has a holistic approach regarding other endocrine diseases such as diabetes mellitus, including diet modifications and exercise without any oral hypoglycaemic medications. His expertise also includes weight management in morbid obesity patients. Dr. Sreeramaneni has been practicing endocrinology for the past nine years in India and participates in international medical conferences.
Amulya Yalamanchi
Amulya Yalamanchi, MD, DM, is a medical practitioner and a board-certified endocrinologist at Yalamanchi Hospital and Research Center, Vijayawada, Andhra Pradesh, India. Her clinical research interests have been in the areas of adult and pediatric endocrine disorders, nutrition and nutrigenomics. Dr. Yalamanchi is a member of the Endocrine society of Tamil Nadu, India.
Manikyeswara Rao Konda
Manikyeswara Rao Konda, BAMS, is an Ayurvedic doctor and a practicing physician at Suraksha Health Village, Vijayawada, Andhra Pradesh, India. He has been a consultant physician of Ayurveda and Yoga at Shanti Ashramam, Visakhapatnam, and Citi Cardiac Research Center, Vijayawada, Andhra Pradesh, India. Dr. Konda has vast experience in clinical research as a principal investigator or a co-investigator in arthritis, obesity, asthma, and sports nutrition clinical trials. He has authored 17 books in Ayurveda and Yoga and several clinical research publications in peer-reviewed journals.
Sree Harsha Varma Cherukuri
Sree Harsha Varma Cherukuri, MD, DM, is a medical practitioner and board-certified endocrinologist at Harsha Diabetes & Endocrine Clinic, Bhimavaram, West Godavari, Andhra Pradesh, India. His clinical research interests have been in diabetes and other endocrine disorders. Dr. Cherukuri is a member of several professional societies, including the American Diabetes Association and the Indian Medical Association.
Joseph C. Maroon
Joseph C. Maroon, MD, is a board-certified clinical professor of neurological surgery at the University of Pittsburgh Medical Center and the Heindl Scholar in Neuroscience. His clinical and research interests have been in the areas of the development of minimally invasive surgical procedures to the brain and spine, the prevention and treatment of traumatic injuries to the central nervous system, innovative approaches to the pituitary and other brain tumors, and more recently complementary approaches to inflammatory diseases associated with aging. For over 20 years, he has served as the neurosurgical consultant to professional and college athletes in football, baseball, golf, hockey, and soccer. He has been honored by the neurosurgical societies of Japan, Korea, Thailand, Egypt, Brazil, Lebanon, and China for his neurosurgical contributions. He is a member of several professional organizations, including the American Academy of Anti-Aging Medicine and the American College of Sports Medicine. Dr. Maroon won several distinguished awards, including the UPMC Physician Excellence Award: Clinician of Courage in 2020. He has published more than 220 research articles in several clinical journals.