Efficacy and safety of flaxseed hull extract in the symptomatic management of benign prostatic hyperplasia

Rudy Simons | Navneet Sonawane | Jayesh Chaudhary | Marian Verbruggen

Journal of Medicinal Food, 2015

The study included men with an American Urological Association Symptom Index (AUASI) score of ≥ 13 and finally, 60 completers were assessed at the end of 8 weeks also for post voiding urine, prostate size, serum testosterone, and DHT. Significant improvement of obstructive symptoms and better management of irritable BPH symptoms were achieved in all groups after treatment. The sponsor of this study was Frutarom with worldwide sales of its functional ingredients. Hence, the study was completed to comply with ICH-GCP guidelines and other applicable regulations for human biomedical research to make study results globally acceptable.

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Efficacy and safety of two polyherbal combinations in male sexual dysfunction

Mugdha P. Kulkarni | Bhakti S. Shinde | ManojShinde | Manoj Kumar V. Chaudhari | Ganesh M. Avhad | Shrikant V. Pensalwar | B. S. V. Prasad | Manoj Kumar M. Deshpande | Richard A. Rosenbloom.

American Journal of Therapeutics, 2011

There was a dearth of well-designed studies on dietary supplements for sexual function in men. The Vedic team chose the gold standard scales used in sildenafil research to assess two doses of HeezOn for the 4 domains of sexual function viz. libido (arousal), erectile function, ejaculatory function (time to ejaculate) and sexual satisfaction. For the first time, we also evaluated the sexual satisfaction of the female partner for a supplement that was taken by the male volunteers. It was a large triple-blind placebo-controlled study with n=147 completers and required vigilant site training, monitoring, and auditing to ensure compliance and limit bias in the absence of any objective assessments. Both doses of HeezOn were well tolerated and better than placebo in improving several domains of sexual function in middle-aged men. This study gave confidence to a DRTV group to successfully launch their brand through TV infomercials in the US in an otherwise controversial category full of unsubstantiated claims.

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Evaluation of a multi-herb supplement for erectile dysfunction

Rudy Simons | Navneet Sonawane | Jayesh Chaudhary | Marian Verbruggen

Journal of Medicinal Food, 2015

Confident from conducting high-quality men’s health studies across multiple GCP-compliant sites in the Mumbai metropolitan area, Vedic took on a few more projects. Noteworthy was a study for VigRX Plus, a supplement that was already doing well through e-commerce. Seventy-eight men aged 25–50 years of age, with mild to moderate erectile dysfunction (ED), participated in this RCT. VigRX Plus was well tolerated and more effective than a placebo in improving sexual function in men. The study results were widely viewed online even today, helped the sponsor defend their claims and generate good returns on their study investment. As usual, the study sites and data were monitored by team monitors (clinical research associates) and all trial-related activities audited by an independent quality assurance manager.

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Effect of Arjun tree bark extract on cardiac conditioning in young, exercising adults

Robert N. Girandola | Dr.Shalini Srivastava

American Journal of Therapeutics, 2016

Cardiac health is a determinant of athletic performance. Typically endurance products test for VO2 max but only a few investigate the underlying mechanism of such improvement in total aerobic capacity. Vedic Lifesciences planned a trial for a Terminalia arjuna (TA) extract “Oxyjun” to study specifically the cardiac component of VO2 max by measuring the left ventricular ejection fraction (LVEF) in healthy young adults using 2D-echocardiography. Thirty-two healthy males, aged 18–40 years performing regular endurance exercise, were randomly assigned to the extract or placebo. Fifty-six days of Oxyjun supplementation significantly improved LVEF and decreased myocardial performance index. Oxyjun reduced fatigue as assessed by Borg’s rated perceived exertion scale. There was no significant change in creatine kinase-MB and troponin-T indicating no cardiac damage. Oxyjun significantly increased cardiovascular efficiency and improved cardiac conditioning in young healthy adults.

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Evaluating the effect of grape seed, Indian gooseberry, turmeric, and fenugreek on regulation of glucose metabolism

Sangeeta Banerji | Shanta Banerjee

European Journal of Integrative Medicine, 2016

A Phyto-medicine company based in Germany contracted Vedic to evaluate their herbal product (Plantabetics) containing extracts of grape seed, Indian gooseberry, turmeric and fenugreek seeds for glycemic control. This 84-day study involved 50 type-2 diabetics not showing any improvement in glycemic control through their regular medication. Plantabetics helped improve average glycated hemoglobin value, average fasting and post-prandial blood sugar values in most of the study population. This study we are told helped expand Plantabetics’ global reach.

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Comparison of elastic therapeutic tape and knee guard in providing support to the knee joint  

 Hoong Keong Hui | Narayan J Karne | Navneet Sonawane

Open Access Journal of Clinical Trials, 2014

This pilot study collected data on clinical outcomes and assessed if a single tape application over the knee joint could provide benefits like those of a conventional knee guard. Thirteen OA subjects were randomly assigned to either Acti-Tape or a knee guard. The main outcome measures were changed in pain visual analog score, timed up-and-go, medial step down, unilateral anterior reach tests and subject’s preference. The improvement in clinical symptoms from the single tape application was similar to that obtained from the knee guard. The participants preferred Acti-Tape to knee guard for future use.

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Investigation of  herbal amino acid supplement in subjects with established osteoarthritis of the knee

Mark J. S. Miller | Ross Butler

Advances in Bioscience and Biotechnology, 2012

This study investigated a redox-active medicinal plant and L-leucine mixture (HLM) in subjects with established osteoarthritis of the knee. Ninety-six subjects were enrolled and randomized to either placebo or HLM treatment. The HLM group received a combination of Uncaria tomentose, Boswellia serrata, Lepidium meyenii and L-Leucine given as 3 capsules once a day. The primary outcome was a reduction in the total WOMAC score. HLM was more effective than a placebo in reducing pain, stiffness, and immobility. HLM has successfully launched in mass retail across America as well as Amazon as Flexsure and then later acquired by a supplement major from the innovator Vital-G-netics, USA.

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Efficacy and safety of a polyherbal preparation in moderate to severe symptoms of osteoarthritis

Mugdha P. Kulkarni | Aliya Shakeel | Bhakti S. Shinde | Richard A. Rosenbloom

American Journal of Therapeutics, 2011

The efficacy and safety of a joint health supplement E-OA-07 (Lanconone^®) were compared against placebo in patients with moderate to severe osteoarthritis of the knee. After 12 weeks of supplementation, there was a significant reduction in pain, stiffness, and physical function in the E-OA-07 group. The subjects’ opinion was significantly greater in favor of E-OA-07 than placebo. E-OA-07 was well tolerated, superior, and more persistent than a placebo in relieving moderate to severe symptoms of osteoarthritis of the knee.

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A clinical trial comparing Lanconone^® with Ibuprofen for rapid relief in acute joint pain

Robert N. Girandola | Dr. Shalini Srivastava | Costas C. Loullis

BioMed Central: Trials, 2016

The joint health supplement market was crowded with products that claimed pain relief, however, none could substantiate a benefit in a few hours. The objective was to study the onset of action of Lanconone^® on acute pain on exertion. Hence, a standard of care, ibuprofen was chosen as an ethical and strong comparator. The trial recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Uphill walking on a treadmill was provided as the stressor before and after the administration of both products. The double-blinded study successfully demonstrated for the first time that a herbal supplement could relieve pain as fast and as much as ibuprofen.

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Comparison of glucosamine sulfate and a polyherbal supplement in osteoarthritis of the knee

Komal Mehta | Nivedita Deo | Jayesh Gala | Surendra Bhasale | Sattayasheel Naik | Millind Modak | Harshad Thakur | Mark JS Miller

BMC Complementary and Alternative Medicine, 2007

This study for a US client compared a dietary supplement (Reparagen^®) derived from South American botanicals to glucosamine sulfate in 95 OA subjects swiftly recruited across multiple GCP trained clinics in the densely populated metro Mumbai. Both the supplement and glucosamine sulfate produced substantial improvements in pain, stiffness and function. Response rates were high, and the safety profile was excellent. There was significantly less rescue medication use with Reparagen^®. With this study Vedic also set new benchmarks in the “Triple layered quality control of clinical data” with its team of site coordinators at the clinical sites, the clinical research associates monitoring the data periodically and the auditors auditing the overall project. The client appreciated the truly “verified” clinical evidence and launched a retail brand based on these results.

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Evaluation of a natural mineral supplement for joint protection potential

Mark JS Miller | Komal Mehta | Sameer Kunte | Anil Shukla | Hemant Tupalli | Himanshu Parikh | Jayesh Chaudhary | Vidyanand Raut | Jayesh Gala | Ramesh Dhumale | Paul Bobrowski.

Journal of Inflammation, 2005

A Canadian group approached Vedic in 2004 to conduct a study in India that would be acceptable to US regulators. This was the first study for us that had to meet US standards because so far we had been serving only the Indian market. We took up the challenge to design a study to meet FTC and FDA standards for dietary supplement clinical research. This study was to determine the joint protection potential of a natural mineral supplement, Sierrasil with and without cat’s claw extract. Possibly for the first time, the gold standard of human research – Good Clinical Practice (ICH/FDA GCP) was applied to a food supplement study. Our client received an NPN based on this publication and went on to use these label claims in Canada as well as in the US.

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Effect Of E-OA-07 On Improving Joint Health And Mobility In Individuals With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Shalini Srivastava | Jayesh A Chaudhary | Robert N Girandola

Journal of Pain Research, 2019.

The study was conducted to assess the effect of IP in subjects with osteoarthritis with mild to moderate pain. The effect of the treatment on rescue medication consumption which is directly proportional to the degree of pain was also be captured via this study. the efficacy parameters such as effect on various joint health parameters (pain, stiffness and physical activity) were studied by using the WOMAC scale. The individuals with knee OA suffer from an increased impact on their activities of daily living, leading also to an important decrease in their quality of life. Thus, an important outcome to be evaluated in this study is the quality of life of these individuals which was also assessed. One of the aims of this study is therefore to investigate the levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after the treatment targeting pain reduction and physical functioning.

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Effect of GenF20 Plus on serum IGF-1 levels in healthy adults

Navneet Sonawane | Jayesh Chaudhary | Vinayak Kale | Suhas Erande

Open Access Journal of Clinical Trials, 2015

GenF20 Plus is a dietary supplement claimed to naturally stimulate the secretion of human growth hormone (HGH) through the anterior pituitary. This study evaluated the effect of GenF20 Plus in enhancing the levels of insulin-like growth factor-1 (IGF-1), which is a marker of HGH levels.

Seventy subjects (35–65 yrs.) visiting five study centers across India, presenting with at least two of age-related complaints (decreased memory, decreased libido, low energy levels and poor quality of sleep) were chosen for the 84-day study.

Sixty-one subjects completed the study as per protocol and were analyzed. GenF20 Plus increased serum IGF-1 levels in the 40-year group who physiologically have reduced IGF-1 levels. The client successfully launched this e-commerce product and continues to do further work with Vedic.

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Study of the mechanism of action of Patch-It^® by assessing blood circulation in patients with mild PAD

Hoong Keong Hui | Surekha Pimple | Navneet Sonawane | Ganesh Shresta

International Journal of Scientific and Research Publications, 2016

There were two challenges for this study for a unique product Patch-It^® – firstly such patients were not easily available for clinical research in most parts of the world including India, and secondly, there were not enough centers with a reliable assessment tool for peripheral arterial disease. A minor challenge was to convince investigators, especially their patients to apply the quaint Chinese patch under their feet every night for a fortnight. Patch-It^® is a TCM patch consisting of mandarin wood vinegar, green tea powder and black tourmaline that is to be applied to soles of the feet in peripheral arterial disease. This pilot study was planned to investigate its possible mechanism of action by assessing the transcutaneous oxygen pressure (TcPO₂) and regional perfusion index (RPI).
The results obtained suggest that the product enhances limb blood circulation by improving microcirculation, through a direct or indirect effect on capillary permeability as evident from changes in TcPO₂ and RPI. Thus, completed a most unique study on a highly traditional Chinese medicine using one of the most sophisticated modern equipment that was available in very few centers in India at that time.

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Effectiveness of Patch It^® in alleviating swelling and ache in the lower legs and feet

Aliya Shakeel | Hoong Keong Hui | Chetan S Patil | Manojkumar V Chaudhari | Yogesh D Kadam | Shrikant V Pensalwar | Suhas G Erande | Rajesh M Kewalramani

Open Access Journal of Clinical Trials, 2012

A Hong Kong-based manufacturer of complementary medicine based on TCM approached Vedic Lifesciences for research on an adhesive patch called Patch-It^®. They were commercializing this medical device in the UK, US, and Asia for swelling, aching and discomfort in the lower limbs. They needed a formal study to substantiate their claims to their target audience as well as regulatory. A total of 100 patients with recurring swelling in the feet were randomized in this placebo-controlled multi-centric study. Patches were applied to both soles overnight for 8 weeks. Patch-It^® was more effective than the placebo in alleviating recurring swelling and aching in the legs and feet.

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Lactobacillus acidophilus DDS‐1 and Bifidobacterium lactis UABla‐12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial

Christopher J. Martoni | Shalini Srivastava | Gregory J. Leyer

Nutrients 2020

Often called “The 5th largest probiotic study in digestive health”, this was a 319 subject trial conducted by Vedic for a US-based probiotic company across 12 sites in India. We studied the effect of 2 probiotic strains and placebo on adult men and women showing symptoms of IBS (Irritable Bowel Syndrome). Our strong network of gastroenterologists (investigators) helped recruit participants for this study over a span of 11 months. This clinical trial implemented reputed tools such as Bristol Stool Scale, IBS-SSS, Rome-IV criteria and APS-NRS. Contact us for the full paper.

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Capsimax increases resting energy expenditure in healthy human subjects under fasting state: A randomized, double-blind, placebo controlled, cross-over study

Dr. Shalini Srivastava | Dr. Asha More

Obesity, Diet and Nutrition, January 2021

The prevalence of obesity in developing and developed countries has been well recognized, and the worldwide obesity rates have nearly tripled since 1975, according to the World Health Organization. CitruSlim, a standardized product containing a blend of Citrus bergamia and Eurycoma longifolia, can reduce cortisol, cholesterol, triglycerides, and hyperglycemia. These properties can contribute to reduction in body weight or body mass index (BMI) in obese patients. A randomized, double-blind, placebo-controlled clinical study was designed to evaluate the efficacy and tolerability of CitruSlim in body weight management in obese individuals, and the results were compared with that of placebo. A total of 97 participants were allocated, randomized, and treated with CitruSlim high-dose (HD, 400 mg), CitruSlim low-dose (LD, 200 mg), and placebo for 112 days. At the end of the study, CitruSlim HD and CitruSlim LD significantly reduced BMI compared to the placebo group and were well tolerated; however, it did not improve parameters associated with dyslipidemia and metabolic disturbances. The study findings suggested that CitruSlim was effective in reducing body weight in obese patients.

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