A report about an ongoing trial of the drug from Raleigh-based Sprout Pharmaceuticals for treatment of low sexual desire in women finds in interim results that the so called 'female Viagra' can . Dongre S, Langade D, Bhattacharyya S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha root in reducing stress and anxiety in adults. Table Table22 summarizes the results obtained for serum cortisol assessment. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. Ashwagandha's possible health benefits for men include: Boosting testosterone levels Enhancing sexual desire Increasing sperm count and motility Improving erectile dysfunction (ED) Reducing blood sugar and inflammation Dry Mouth in Flexeril, how severe and when it was recovered? The range of treatment varies from conventional medication such as neuropsychiatric drugs, cognitive behavioral therapy for insomnia (CBT-I), precision medicine, and alternative medicinal approaches. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love The present 10 weeks study reports the demonstrated impact of the significant improvement in the sleep parameters SOL, SE, PSQI and anxiety parameters HAM-A. The Stress of Life. The study protocol was approved by the Institutional Ethics Committee (IEC Ref. Most benefits are linked to dosages of 225-600 mg per day taken for 1-2 months. All the enrolled patients data were collected as determined in the study protocol, i.e., during baseline estimation, at the 5th week and at the 10th week. Table2). For this reason, this study may be of interest to researchers in alternative medicine seeking herbal remedies for sleep improvement and stress reduction. A number of herbal sources have shown reasonable outcome including Ashwagandha. Anxiety was assessed using the Hamilton-Anxiety (HAM-A) scale and serum cortisol was measured at baseline and at eight weeks. Dapoxetine plasma concentrations rapidly decline to about 5% of C max at 24 hours. Participants were informed about the study and were assessed by the principal investigator for eligibility based on the inclusion/exclusion criteria. Role of shirodhara with ashwagandha taila in management of stress induced insomnia. Experiments using animal models indicated cardio-protective, immunomodulatory, anti-diabetic and neuroprotective effects of Ashwagandha root extracts [12-15]. Ashwagandha found across India and south Asia, is a respected herb intraditional Indian Ayurveda, scientifically known as Withania somnifera (L.) Dunal. Insomnia is a prevalent sleep disorder that can profoundly impact a persons physical health and mental wellbeing. The summed up global score of the seven components estimates the patients sleep quality that varies from 0 to 21. It is often used in generalized anxiety disorder. After assessing the screening parameters, each participant was randomly assigned into either of the three study groups; two study treatment groups: Ashwagandha 250, Ashwagandha 600 and one placebo group. The randomization codes were provided in a separate sealed envelope for each participant and the envelope was opened by the investigator after the subjects were enrolled and received the serial number. The mental alertness on rising for the patients considered in this study was scaled as alert (score 1), slightly drowsy (score 2) and extremely drowsy (score 3). Chronic stress, visceral obesity and gonadal dysfunction. The secondary objectives include comparing the effects of Ashwagandha root extract versus placebo i) on the total sleep time (TST), Wake After Sleep Onset (WASO) and Sleep Efficiency (SE) assessed by actigraphy; ii) on sleep quality using the Pittsburgh Sleep Quality Index (PSQI), mental alertness on rising and sleep quality using Sleep logs; iii) on anxiety score using the Hamilton-Anxiety (HAM-A) scale (Figure (Figure11). However, the SOL was significantly shorter (p, 0.019) after 10 weeks with test [29.00 (7.14)] compared to placebo [33.94 (7.65)]. Insomnia often leads to fatigue, energy depletion, impairment in concentration and increased irritability. About dapoxetine Before taking dapoxetine How to take dapoxetine tablets Can dapoxetine tablets cause problems? These drugs include sildenafil (Viagra), tadalafil (Cialis, Adcirca), avanafil (Stendra) and . Afrasiabian F, Ardakani MM, Rahmani K, et al. A comparative analysis was conducted between the placebo and the test group to understand the participants performance differences among various sleep parameters such as SOL, TST, TIB, and sleep efficiency as represented in Table Table2. HHS Vulnerability Disclosure, Help Sleep quality always has an impact on our overall health conditions. Independent Ethics Committee (IEC) approval was obtained vide letter dated October 30, 2014 from Institutional Ethics Committee, Snehal Hospital, Thane, Maharashtra, India. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The study comprised of an initial screening visit followed by an eight-week treatment period. The PSQI is a self-administered questionnaire resulting to a subjective measure of sleep quality and patterns through estimating the outcome of seven components of sleep quality, i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep-promoting medications, and daytime dysfunction over the period of a month [23]. But so far, there isn't enough information to judge whether it is effective for any of them. An official website of the United States government. The study was conducted in accordance with the Declaration of Helsinki (2013 amendment) and Good Clinical Practice (GCP) guidelines and Ethical Guidelines for Biomedical Research on Human Subjects, issued by the Indian Council of Medical Research (ICMR), were followed [21]. Careers, Unable to load your collection due to an error. It is often used in erection problems. Table Table77 (appendices) represents the study schedule followed. After waking up in the morning, the mental alertness was estimated through a three-point scale to assess the alertness as perceived by the patient where 1 refers to alert, 2 refers to slightly drowsy and 3 signifies extremely drowsy. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. Scope, aims, and objectives. In this current clinical study, the effect of a lower dose of Ashwagandha root extract (Ashwagandha 250 mg/day) was evaluated and compared with the standard dosage of Ashwagandha (Ashwagandha 600 mg/day) and placebo in stressed individuals. Every item estimation score ranges between 0 and 4; higher the score, severe the situation. Lower alertness is noted due to exhaustion, lack of energy, drowsiness, etc. HAM-A is represented by 14 items [24]. This herb is also used traditionally as a tonic to support memory, vitality, and healthy hormonal function, which supports balanced Vata energy.*. This finding was replicated in another study, in which infertile men given 3g of ashwagandha root extract (rather than root powder) for 3-months increased testosterone levels by 14-41% 3 . All content published within Cureus is intended only for educational, research and reference purposes. The present study is the first report in the direction of clinical research where the scientific clinical study is conducted to understand the effect of Ashwagandha root extract on sleep quality in the considered patient population. Clinical safety and tolerability of the interventions were measured by analyzing the significant changes in the vital parameters and the biochemical parameters assayed. Seventy-five participants were screened for participation in the study and 60 participants met the inclusion criteria and were enrolled to participate. The results showed thatWithania somniferainduced a stage of nonspecific increased resistance during stress. A significant reduction in PSS scores was observed with Ashwagandha 250 mg/day (P < 0.05)and 600 mg/day (P < 0.001). Both the test product and the placebo were coated in a capsule of exact shape, size, and colour. Federal government websites often end in .gov or .mil. At baseline, the total time in bed was 346.08 (44.48) for the experimental group and 348.94 (47.81) for control. No. Dapoxetine is another type of SSRI specifically designed to treat premature ejaculation. The Consolidated Standards Of Reporting Trials (CONSORT) guidelines for designing and reporting controlled trials were followed in this study. Earlier, a number of measures to negotiate chronic insomnia have been attempted including nonpharmacological treatment, bedtime restriction, use of receptor antagonists in relation to orexin system for sleep-onset insomnia [25,26]. Reduces inflammation. Choudhary D, Bhattacharyya S, Bose S. Randomized placebo-controlled adjunctive study of an extract of Withania somnifera for cognitive dysfunction in bipolar disorder. Further studies conducted with a larger cohort and in diverse populations and with more biochemical, physiological and psychological evaluation may confirm the present findings. The baseline scores in Ashwagandha 250, Ashwagandha 600 and placebo group were22.65 (1.75), 22.95 (1.57), and 22.70 (2.17), respectively. Family Medicine, Prakruti Hospital, Mumbai, IND, 4 Schwabe L, Dickinson A, Wolf OT. Hence, alternative herbal therapies could be effective in treating insomnia. Thus, 40 patients were considered in the experimental group (test product Ashwagandha capsules) and 20 patients were randomized to the control group (placebo group). Hamilton M. Cognitive and behavioral therapies in the treatment of insomnia: a meta-analysis. Hence, the use of this herb as a supplement for stress and anxiety management could be an excellent alternative option. Participants having any chronic physical, hematological, hormonal or psychiatric illness and history of substance dependence were excluded from the study. The Hamilton Anxiety Rating Scale (HAM-A) was used to assess the intensity of anxiety present in each participant [23]. This was a randomized, double-blind, placebo-controlled study conducted at Prakruti Hospital, Kalwa, Maharashtra, India. Another report suggests that pre-treatedrats with an aqueous suspension of Ashwagandha root extract were successful in decreasing the adrenal cortisol and ascorbic acid levels in animals subjected to swimming stress [25]. All the participants were requested to provide feedback on their sleep quality. Some medications used to treat erectile dysfunction also might help premature ejaculation. Bhattacharya S, Muruganandam A. Antioxidant effect of dietary supplement Withania somnifera L. reduce blood glucose levels in alloxan-induced diabetic rats. Phosphodiesterase-5 inhibitors. The use of herbs to offset these antecedents and outcomes has greatly increased in recent years. World Medical Association. The placebo group participants were given capsules containing 125 mg of starch. studied the safety and efficacy of high concentration and full-spectrum Ashwagandha root extract in reducing stress and anxiety in 64 subjects in a 60-day long clinical trial [24]. FOIA The sleep onset latency was improved in both test and placebo at five and 10 weeks. Those who travelled across four or more time zones or worked on the night or rotating shifts in the previous seven days before study initiation were not considered. The https:// ensures that you are connecting to the Lovato N, Lack L. Clinical guideline for the evaluation and management of chronic insomnia in adults. Some reports may have incomplete information. Data for adverse events were available only for 58 participants as two subjects were lost in follow-up. Stop using Viagra and get emergency medical help if you have sudden vision loss. Bethesda, MD 20894, Web Policies Capsules containing either Ashwagandha root extract (test) or placebo were used for intervention. Ancient Ayurvedic medicine has a remarkable solution for such lifestyle-induced biological and psychological conditions. Smoothie. reported that the active ingredient of Ashwagandha leaves such as tryethylene glycol can induce sleep in mice through reducing the NREM sleep onset latency period [30]. In the present study, baseline scores were compared to the post-treatment scores for the different scales using the Friedman test within the group. Further, those who were taking any other herbal preparations containing Ginseng, Brahmi, Gingko Biloba or similar herbs were not considered for participation in this study. The authors thank Ixoreal Biomed Inc., Los Angeles, California, USA, for supplying the KSM-66 Ashwagandha root extract used in the study. ashwagandha, insomnia, anxiety, sleep onset latency, actigraphy, wake after sleep onset, sleep efficiency. WASO is the duration, a person remains awake after the defined onset of the sleep. Viagra Ashwagandha and Viagra drug interactions - a phase IV clinical study of FDA data Summary: Drug interactions are reported only by a few people who take Ashwagandha and Viagra together. Withania somnifera, known as ashwagandha, has a role in ayurvedic medicine for a wide range of health conditions. Romero K, Goparaju B, Russo K, Westover MB, Bianch MT. Agradual improvement from the baseline to the final assessment in the tenth week was noted inboth groups. Two participants (one each in 250 mg/day Ashwagandha and placebo) were lost to follow-up and 58 participants completed the study. The comparative measure further projects that the treatment with the Ashwagandha root extract powder depicted better outcome in comparison to the placebo group. Sleep quality was assessed for each study participant using standard sleep quality questionnaire during the visits. At baseline, the mean (SD) SOL scores and mean WASO scores for the test group were 41.61 (6.84) and 42.69 (14.66), respectively. The study protocol was approved by the Institutional Ethics Committee (IEC Ref. In the present study, we have investigated the impact of Ashwagandha root extract powder compared to placebo on insomnia patients as a natural solution to the burgeoning problem of insomnia. Sleep actigraphy (Respironics Philips) was used for assessment of sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE) and wake after sleep onset (WASO). The capsules containing Ashwagandha and placebo were of exact shape, size and color, and appearance. Several clinical studies performed using Ashwagandha for various clinical conditions validated that it was well-tolerated and safe. The serum cortisol levels were measured in ug/dL for the present study. General examination and detailed monitoring of respiratory systems, cardiovascular systems, musculoskeletal system, digestive system and nervous system of each subject were done. Internal Medicine, Risk Care Hospital/Prakruti Care Hospital/Jupiter Hospital, Thane, IND, 2 The relationship between chondroprotective and antiinflammatory effects of Withania somnifera root and glucosamine sulphate on human osteoarthritic cartilage in vitro. Similarly, the study duration should be increased to understand the long-term effect of Ashwagandha in patients with insomnia and anxiety. A global measure of perceived stress. 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