A Randomized Placebo Controlled Clinical Trial Demonstrating Safety & Efficacy of EnXtra® in Healthy Adults.

Objective: The present randomized, placebo-controlled study aimed to assess the long-term safety and perceivable mental acuity benefits of EnXtra® in healthy individuals.Methods: Study participants were administered EnXtra® with or without caffeine for a period of 12 weeks. The cardiovascular safety was evaluated by assessing change in QT interval, blood pressure and heart rate. Further, other efficacy variables evaluated were change in perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale.Results: None of the study group showed any significant change in the ECG or haemodynamic parameters as compared to baseline (p > 0.05). Post consumption, alertness and calmness scores were significantly increased in the EnXtra®, and EnXtra® plus caffeine group (p < 0.001) as compared to placebo. Daytime sleep scores decreased in the EnXtra® group however change was not significant. Sleep quality remained undisturbed in all three arms.Conclusion: The findings demonstrated the psychostimulant efficacy of EnXtra® with no safety concerns on long-term usage.

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.

AIM: The aim of the present study was to evaluate the effect of E-OA-07 on individuals having osteoarthritis of the knee. BACKGROUND: Lanconone® (E-OA-07) is a widely marketed dietary supplement which has been previously studied in different clinical settings for managing chronic joint pain. This was a confirmatory study planned at a lowered dose regimen with the purpose of improving compliance and reducing consumer cost. METHODS: Male and female participants aged between 40 and 65 years, with history of joint pain for at least 3 years, were recruited. Knee joint dysfunction of grade II/III was radiographically characterized as per Kellgren-Lawrence system of classification. Enrolled participants were randomized to receive E-OA-07 at a dose of 1000 mg/day or placebo over a period of 8 weeks. The primary efficacy parameter was assessment of change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Whereas, the secondary parameters explored in the study included WOMAC subscales of stiffness and physical function, EQ-5D-5L questionnaire, systemic inflammatory marker (hs-CRP) and self-assessment of treatment satisfaction. RESULTS: At the end of 8 weeks, joint pain severity as per WOMAC was found to be significantly reduced in the E-OA-07 group as compared to placebo (p<0.001). Similar improvement was observed in the subscales of stiffness and physical function which corresponds to significant improvement in the quality-of-life standards of E-OA-07 participants (p<0.001), reporting higher treatment satisfaction (p<0.001). CONCLUSION: E-OA-07 at a dose of 1000 mg/day was able to significantly reduce joint pain and thereby improve joint mobility in study participants. At the end of the study period, there was a clinically relevant change of 45.55%, 45.91% and 38.19% for pain, stiffness and physical function, respectively. Moving forward, studies could be planned for understanding the cartilage regenerative properties of E-OA-07.

Efficacy and safety of a flaxseed hull extract in the symptomatic management of benign prostatic hyperplasia: a parallel, randomized, double-blind, placebo-controlled, pilot study.

This exploratory study was designed to assess the effectiveness of a lignan-rich extract of flaxseed hulls (LinumLife EXTRA(®)) in alleviating symptoms in subjects with benign prostatic hyperplasia (BPH) compared with placebo. Two dosages of extract were compared against placebo in a double-blinded, randomized, parallel, multicenter study. Newly diagnosed cases of BPH in patients aged 45-75 years with an American Urological Association Symptom Index (AUASI) score of ≥13 were included. Study treatment consisted of 500 or 1000 mg of extract containing 100 mg (low-dose active [LDA] group, n=26) or 200 mg (high-dose active [HDA] group, n=26) of secoisolariciresinol diglucoside (SDG), respectively. The placebo (P) group (n=28) received matching maltodextrin capsules. Sixty subjects (LDA [n=19], HDA [n=20], and P [n=21]) completed the study as per the protocol requirements. Change in the AUASI score within a period of 8 weeks, from baseline to end of treatment, was assessed. Significant improvement of obstructive symptoms and management of irritable BPH symptoms was achieved in all groups after treatment. Due to a strong placebo effect, there was no statistical difference between the groups that were treated with flaxseed hull extract as compared with the placebo group. Treatment with flaxseed hull extract did not lead to adverse effects compared with placebo. Supplementation with flaxseed hull extract was found to be safe and well-tolerated and may have improved the quality of life of individuals with BPH. The significant placebo effect as well as the number of subjects per treatment group and the relative short duration of the study may explain the lack of statistical significance between groups.

Traditional botanical medicine: an introduction.

The role of traditional medicine in the well-being of mankind has certainly journeyed a long way. From an ancient era, in which knowledge was limited to a few traditional healers and dominated by the use of whole plants or crude drugs, the science has gradually evolved into a complete healthcare system with global recognition. Technologic advancements have facilitated traditional science to deliver numerous breakthrough botanicals with potency equivalent to those of conventional drugs. The renewed interest in traditional medicine is mainly attributed to its ability to prevent disease, promote health, and improve quality of life. Despite the support received from public bodies and research organizations, development of botanical medicines continues to be a challenging process. The present article gives a summarized description of the various difficulties encountered in the development and evaluation of botanical drugs, including isolation of active compounds and standardization of plant ingredients. It indicates a future direction of traditional medicine toward evidence-based evaluation of health claims through well-controlled safety and efficacy studies.

Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: a randomized controlled trial [ISRCTN38432711].

BACKGROUND: This study was designed to determine if a natural mineral supplement, sierrasil, alone and in combination with a cat's claw extract (Uncaria guianensis), vincaria, has therapeutic potential in mild to moderate osteoarthritis of the knee. METHODS: Patients (n = 107) with mild to moderate osteoarthritis of the knee were randomly assigned to one of 4 groups; high dose sierrasil (3 g/day), low dose sierrasil (2 g/day), low dose sierrasil (2 g/day) + cat's claw extract (100 mg/day) or placebo, administered for 8 weeks. Treatment was double blinded. Primary efficacy variables were WOMAC scores (A, B, C and total). Visual analog score (VAS) for pain, consumption of rescue medication (paracetamol), and tolerability were secondary variables. Safety measures included vital signs and laboratory-based assays. RESULTS: Ninety-one of the 107 patients successfully completed the protocol. All four groups showed improvement in WOMAC and VAS scores after 8 weeks (p < 0.001), in all 3 groups receiving sierrasil the magnitude of benefits were greater vs. placebo (WOMAC Total 38-43% vs. 27%) but this was not statistically significant. In reference to baseline values sierrasil treated groups had a considerably faster onset of benefits. Placebo-treated individuals failed to show significant benefits at 4 weeks (11% reduction in total WOMAC). In contrast, after 1 or 2 weeks of therapy all the sierrasil groups displayed significant reductions in WOMAC scores (p < 0.05) and at week 4 displayed a 38-43% improvement. VAS was significantly improved at 4 weeks in all groups (p < 0.001) but was significantly greater in all sierrasil groups compared to placebo (p < 0.05). Rescue medication use was 28-23% lower in the herbomineral combination and high dose sierrasil groups although not statistically different from placebo (P = 0.101 and P = 0.193, respectively). Tolerability was good for all groups, no serious adverse events were noted and safety parameters remained unchanged. CONCLUSION: The natural mineral supplement, sierrasil alone and in combination with a cat's claw extract, improved joint health and function within 1-2 weeks of treatment but significant benefits over placebo were not sustained, possibly due to rescue medication masking. Sierrasil may offer an alternative therapy in subjects with joint pain and dysfunction.