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A Comparative Study to Evaluate Efficacy of Curcumin and Aloe Vera Gel along with Oral Physiotherapy in the Management of Oral Submucous Fibrosis: A Randomized Clinical Trial.
Nerkar Rajbhoj, A, Kulkarni, TM, Shete, A, Shete, M, Gore, R, Sapkal, R
Asian Pacific journal of cancer prevention : APJCP. 2021;(S1):107-112
Abstract
UNLABELLED Rationale (Hypothesis): The antioxidant,anti-inflammatory,immunomodulatory and anti-tumorigenic properties of natural plant's extracts like aloe Vera and curcumin may produce beneficial therapeutic effects on OSMF patients and may lead to their symptomatic relief. Also, increase in the tissue elasticity with the help of oral physiotherapy excercises , would help in reinforcing increment in mouth opening. AIM: The aim of the study is to compare the efficacy of Curcumin gel with Aloe Vera gel when both the gel are supplemented along with oral physiotherapy in the management of OSMF. MATERIALS AND METHODS A study of parallel group trial design, using simple randomization technique, was conducted on confirmed cases of OSMF. Patients were divided into two groups, one group(30 patients) was given curcumin gel(Curenext) and other group (30 patients) aloe Vera gel (Aloe Vera 100% relief) and each group was asked to do same oral physiotherapy excercises supplementally. Follow-up was done for 6 weeks and patients were assessed on the basis of improvement in mouth opening and burning sensation at 2, 4, and 6 weeks. RESULTS There was an improvement in both the parameters at subsequent visits, but the Aloe Vera gel showed better improvement than curcumin gel in burning sensation after 6 weeks of treatment which was highly statistically significant p < 0.01. CONCLUSION Curcumin gel and Aloe Vera gel are effective in improving OSMF symptoms, but aloe Vera gel is more efficacious in burning sensation improvement without any side effects. Hence, we can advocate these drugs as adjuvant treatment in addition to the recommended treatment.
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Efficacy of Pomegranate Seed Powder on Glucose and Lipid Metabolism in Patients with Type 2 Diabetes: A Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial.
Seyed Hashemi, M, Namiranian, N, Tavahen, H, Dehghanpour, A, Rad, MH, Jam-Ashkezari, S, Emtiazy, M, Hashempur, MH
Complementary medicine research. 2021;(3):226-233
Abstract
INTRODUCTION Pomegranate is known as a functional food which has multiple health-promoting activities. It has been assessed for patients with metabolic syndrome. Specifically, an antidiabetic activity of its juice and plausible mechanisms for its action have been shown in multitudinous studies. The aim of this study was assessing the effects of complementary treatment with pomegranate seed powder (PSP) oral supplementation on patients with type 2 diabetes mellitus (T2DM). METHODS Sixty patients were treated for 8 weeks by 5 g PSP or placebo, twice daily. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), total cholesterol, and triglyceride (TG) were recorded as the outcome measures at the beginning and after the intervention. The findings were analyzed using the independent t test and Mann-Whitney U test. RESULTS After 8 weeks, the mean differences of FBG, HbA1c, cholesterol, and TG were significantly decreased in the PSP group when compared with the placebo group (p value <0.05). In addition, post-intervention values of FBG and HbA1c were significantly lower in patients treated with PSP compared to the placebo group (p values = 0.02 and 0.01, respectively). However, the latter comparison regarding cholesterol and TG showed no significant differences (p values = 0.51 and 0.26, respectively). CONCLUSION It seems that complementary treatment with PSP may have beneficial effects on FBG and HbA1c of patients with T2DM. However, its effect on TG and cholesterol was equivocal.
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Safety and Efficacy of Oral Supplementation of Lentil (Lens culinaris Medic) in Dry Eye Patients.
Panahi, Y, Roozbahani, M, Pirhadi, S, Aghamollaei, H, Nejat, F, Naderi, M, Serahati, S, Jadidi, K, Sathyapalan, T, Jamialahmadi, T, et al
Advances in experimental medicine and biology. 2021;:377-384
Abstract
OBJECTIVE To evaluate the safety and efficacy of dietary lentil capsules in patients suffering from dry eye symptoms. METHODS A randomized, triple-blind, interventional, placebo-controlled study was done. Sixty patients were randomized in two groups to receive either one capsule containing 500 mg of lentil powder or placebo daily for 3 months. UCVA, tear film breakup time (TBUT), Schirmer's test, tear film osmolarity, and OSDI score were recorded at baseline and 3 months after intervention. Data analysis was performed using IBM SPSS for Windows version 20 (SPSS, Chicago, IL, USA). RESULTS In the lentil group, at baseline, the mean UCVA (LogMAR), OSDI, TBUT (S), tear film osmolarity (mOsm/L), and Schirmer (mm) scores were 0.104 (0.026), 22.66 (19.40), 10.31 (5.32), 301.07 (15.57), and 8.22 (6.87), respectively. These values were 0.101 (0.026), 20.85 (19.44), 13.04 (7.11), 299.81 (11.60), and 9.87 (10.11). In the placebo group, these values were 0.084 (0.027), 25.35 (20.08), 10.56 (4.95), 299.77 (15.09), and 9.35 (8.06) at baseline and 3 months later were 0.077 (0.027), 23.32 (22.90), 13.62 (6.30), 297.54 (12.08), and 8.64 (9.60), respectively. Three patients (one in the lentil group and two in the placebo group) experienced severe gastrointestinal symptoms. CONCLUSION Although consumption of 500 mg of lentil is safe, this amount is not sufficient for reduction of dry eye syndrome in 3 months. For more validation, a clinical study with increased dosage of lentil is proposed.
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Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients.
Devpura, G, Tomar, BS, Nathiya, D, Sharma, A, Bhandari, D, Haldar, S, Balkrishna, A, Varshney, A
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153494
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Abstract
BACKGROUND Specific treatment for COVID-19 is still an unmet need. Outcomes of clinical trials on repurposed drugs have not been yielding success. Therefore, it is necessary to include complementary approaches of medicine against COVID-19. PURPOSE This study was designed to evaluate the impact of traditional Indian Ayurvedic treatment regime on asymptomatic patients with COVID-19 infection. STUDY DESIGN It is a placebo controlled randomized double-blind pilot clinical trial. METHODS The study was registered with Clinical Trial Registry-India (vide Registration No. CTRI/2020/05/025273) and conducted at the Department of Medicine in National Institute of Medical Sciences and Research, Jaipur, India. 1 g of Giloy Ghanvati (Tinospora cordifolia) and 2 g of Swasari Ras (traditional herbo-mineral formulation) and 0.5 g each of Ashwagandha (Withania somnifera) and Tulsi Ghanvati (Ocimum sanctum) were given orally to the patients in treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While, Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post randomization and double blinded assortments. RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α) and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study. RESULTS By day 3, 71.1 % and 50.0 % patients recovered in the treatment and placebo groups, respectively. Treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6 and TNF-α in treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group. CONCLUSIONS Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.
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Effectiveness of the piperine-supplemented Curcuma longa L. in metabolic control of patients with type 2 diabetes: a randomised double-blind placebo-controlled clinical trial.
Neta, JFF, Veras, VS, Sousa, DF, Cunha, MDCDSO, Queiroz, MVO, Neto, JCGL, Damasceno, MMC, Araújo, MFM, Freitas, RWJF
International journal of food sciences and nutrition. 2021;(7):968-977
Abstract
There is robust evidence of using Curcuma longa L. in reducing metabolic levels in people with diabetes. This study analysed the effectiveness of Curcuma longa L. in the metabolic control of patients with type 2 diabetes in Brazil. A randomised double-blind placebo-controlled clinical trial was conducted with 71 participants divided into a Curcuma longa L. group (500 mg/day with piperine 5 mg) and a placebo group, for 120 days. Anthropometric, clinical and biochemical variables were evaluated at baseline, 60 and 120 days after the beginning of the intervention. Paired and independent Student's t-test and chi-square test were used for statistical analysis. The curcuma group presented a significantly decreased glycaemia (p=.013), glycated haemoglobin (p=.015), HOMA index (p=.037) and triglycerides (TGs) (p=.002). The use of piperine-added Curcuma longa L. was effective in the glycaemic and TG control of patients with type 2 diabetes.
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Effect of processed aloe vera gel on immunogenicity in inactivated quadrivalent influenza vaccine and upper respiratory tract infection in healthy adults: A randomized double-blind placebo-controlled trial.
Hwang, JH, Oh, MR, Hwang, JH, Choi, EK, Jung, SJ, Song, EJ, Españo, E, Webby, RJ, Webster, RG, Kim, JK, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153668
Abstract
BACKGROUND Aloe vera is a functional food with various pharmacological functions, including an immune-modulating effect. Until now, A. vera has never been studied as an adjuvant in influenza vaccine, and its effects on upper respiratory tract infection (URI) are unknown. PURPOSE The objective of our study was to investigate the effect of processed A. vera gel (PAG) on immunogenicity of quadrivalent inactivated influenza vaccine and URI in healthy adults. STUDY DESIGN A randomized, double-blind, placebo-controlled clinical trial was performed. METHODS This study was conducted in 100 healthy adults at a single center from September 2017 to May 2018. Subjects were randomly divided into a PAG group (n = 50) and a placebo group (n = 50). The enrolled subjects were instructed to ingest the study drug for 8 weeks. The participants received a single dose of quadrivalent inactivated influenza vaccine after taking the study drug for the first 4 weeks of the study. The primary endpoint was seroprotection rate against at least one viral strain at 4 weeks post-vaccination. Other outcomes were seroprotection rate at 24 weeks post-vaccination, seroconversion rate, geometric mean fold increase (GMFI) at 4 and 24 weeks post-vaccination, seroprotection rate ratio and geometric mean titer ratio (GMTR) at 4 weeks post-vaccination between PAG and placebo groups, and incidence, severity, and duration of URI. RESULTS The European Committee for proprietary medicinal products (CPMP) evaluation criteria were met at least one in the PAG and placebo groups for all strains. However, there was no significant difference in the seroprotection rate at 4 weeks post-vaccination against all strains in both PAG and placebo groups. Among secondary endpoints, the GMFI at 4 weeks post-vaccination for the A/H3N2 was significantly higher in the PAG than in placebo group. The GMTR as adjuvant effect was 1.382 (95% CI, 1.014-1.1883). Kaplan-Meier curve analysis showed a reduction in incidence of URI (p = 0.035), and a generalized estimating equation model identified a decrease in repeated URI events (odds ratio 0.57; 95% CI, 0.39-0.83; p = 0.003) in the PAG group. CONCLUSIONS Oral intake of PAG did not show a significant increase in seroprotection rate from an immunogenicity perspective. However, it reduced the number of URI episodes. A well-designed further study is needed on the effect of PAG's antibody response against A/H3N2 in the future.
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Assessment of Passiflora incarnata L for conscious sedation of patients during the extraction of mandibular third molars: a randomized, split-mouth, double-blind, crossover study.
Christoffoli, MT, Bachesk, AB, Farah, GJ, Ferreira, GZ
Quintessence international (Berlin, Germany : 1985). 2021;(10):868-878
Abstract
OBJECTIVE The aim of the present study was to evaluate the efficacy of Passiflora incarnata L for the control of anxiety during third mandibular molar extraction and compare it to midazolam, the most used benzodiazepine in dentistry. METHOD AND MATERIALS The investigators implemented a prospective, randomized, double-blind, split-mouth study. The degree of anxiety of the patients was assessed before the surgical procedure. The surgeries took place in two sessions: one on each side of the hemi-mandible and, on each of them, the patient received one of the drugs, crosswise. Anxiety control was measured through physical parameters, at the following periods during the surgery: (1) immediately administration of anxiolytic medication, (2) 30 minutes after anxiolytic medication, (3) after extraoral antisepsis, (4) after local anesthesia, (5) during incision, (6) during osteotomy, (7) between osteotomy and odontosection, (8) during odontosection, (9) during surgical store curettage, (10) during suture, and (11) immediately after postoperative care guidelines. Lastly, the volunteers received a self-assessment form in order to report their experience. Statistical analysis was performed using the Wilcoxon test. RESULTS The final sample was composed of 20 patients, with a mean age of 22.5 years. The results of the physical parameters showed statistically significant differences (P < .05) for certain times and physical parameters, especially heart rate (P = .036), which showed the highest control for Passiflora at time point (3). The undesirable effects reported by patients such as drowsiness, muscle relaxation, and dizziness were greater with benzodiazepine. CONCLUSION The results of this study suggest that Passiflora may be considered as an alternative to midazolam in controlling anxiety in dentistry. Future studies will focus on other benzodiazepines and herbal medicines.
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Effects of garlic powder supplementation on metabolic syndrome components, insulin resistance, fatty liver index, and appetite in subjects with metabolic syndrome: A randomized clinical trial.
Sangouni, AA, Alizadeh, M, Jamalzehi, A, Parastouei, K
Phytotherapy research : PTR. 2021;(8):4433-4441
Abstract
The prevalence of metabolic syndrome (MetS) is increasing. It is closely linked to nonalcoholic fatty liver disease. Garlic consumption as a strategy for the management of MetS has been suggested. We investigated the effect of garlic supplementation on MetS components, insulin resistance, fatty liver index (FLI), and appetite in subjects with MetS. Ninety subjects were assigned to receive 1,600 mg/d garlic powder or placebo for 3 months. The primary outcomes included MetS components. The secondary outcomes included insulin resistance, FLI, and appetite. Garlic supplementation compared with the placebo led to a significant increase in high density lipoprotein-cholesterol (4.5 vs. -1.8, p < .001) and a significant reduction in waist circumference (-1.3 vs. 0.0, p = .001), diastolic blood pressure (-6.7 vs. 0.0, p < .001), systolic blood pressure (-7.7 vs. 0.5, p < .001), triglyceride (-40.0 vs. 0.1, p < .001), γ-glutamyl transferase (-3.2 vs. 0.6, p = .01), FLI (-5.5 vs. 0.1, p < .001), insulin (-2.9 vs. -1.1, p < .001), homeostatic model of assessment for insulin resistance (-0.5 vs. -0.3, p < .001) and appetite (hunger: -11.7 vs. 1.7, p < .001; fullness: 10.0 vs. 0.3, p = .001; desire to eat: -6.7 vs. 2.1, p < .001; and ability to eat: -11.5 vs. -1.0, p < .001). Garlic improves MetS components, insulin resistance, FLI, and appetite.
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Cost-Effectiveness of Passion Fruit Albedo versus Turmeric in the Glycemic and Lipaemic Control of People with Type 2 Diabetes: Randomized Clinical Trial.
Sousa, DF, Araújo, MFM, de Mello, VD, Damasceno, MMC, Freitas, RWJF
Journal of the American College of Nutrition. 2021;(8):679-688
Abstract
BACKGROUND Robust evidence has related yellow passion fruit albedo and long turmeric to the metabolic and glycemic control of diabetes. AIM: To analyze the incremental cost-effectiveness of the flour made from yellow passion fruit albedo versus long turmeric merged with piperine in the glycemic and lipid control of individuals with type 2 diabetes. METHOD Eighty-nine patients were enrolled in this randomized, placebo-controlled, clinical trial for 120 days. The first group was prescribed 500 mg capsules, three times a day, of yellow passion fruit albedo flour (FAMA). The second group was prescribed long turmeric capsules (500 mg), merged with piperine (5 mg) (CURPI), at fasting. The third group followed the standard advice recommendations, and ingested a placebo of carboxymethyl cellulose (500 mg) at fasting. RESULTS The group using FAMA showed a higher reduction (-5.9%) of glycemia after fasting, compared to placebo (+9%), and CURPI (-3.2%) (p < 0.05). Regarding HbA1c, the study observed a significant and similar statistical reduction (-0.8%) in the intervention groups, in contrast with the placebo group (p < 0.05). The reduction in HOMA-IR in the CURPI group (-9.4%) was higher than the other groups (p < 0.05). The CURPI group also showed a higher reduction of serum triglyceride levels (-20.8%) compared to the placebo (-0.09%) and FAMA (+1.8%) (p < 0.05) groups. CONCLUSION It was concluded that turmeric is the most cost-effective in comparison with yellow passion fruit albedo, because of its decrease in the levels of triglycerides and HOMA-IR, even when adjusted for confounding variables. On the other hand, HbA1c cost-effectiveness relation was similar.
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Ayurvedic Herbal Preparation Supplementation Does Not Improve Metabolic Health in Impaired Glucose Tolerance Subjects; Observations from a Randomised Placebo Controlled Trial.
Esser, D, Matualatupauw, J, de Vos, RCH, Wehrens, R, van der Stappen, J, van der Meer, I, Afman, LA
Nutrients. 2021;(1)
Abstract
The increased usage of alternative Ayurvedic treatments as potential health-beneficial therapies emphasizes the importance of studying its efficacy in sound placebo-controlled intervention trials. An example of such a traditional Ayurvedic herbal preparation is Mohana Choorna, a mixture composed of 20 different herbs and used to prevent and treat type 2-diabetes (T2D). We studied the efficacy of "Mohana Choorna" on T2D-related parameters in subjects with impaired glucose tolerance. In a double blind, placebo-controlled cross-over trial, 19 overweight (BMI > 27 kg/m2) subjects aged 50-70 years with an impaired glucose tolerance received two four-week interventions, i.e., herbal or placebo with a four-week wash-out between interventions. HbA1c, glucose, insulin, triglycerides, cholesterol, blood pressure and augmentation index were measured before and after both interventions at fasting and during a glucose tolerance test. After both interventions, urine was collected to measure treatment exposure using LCMS-based metabolomics and whole genome gene-expression in adipose tissue of 13 subjects. The herbal intervention did not affect plasma glucose triglycerides, cholesterol, blood pressure or the augmentation index but showed a trend towards an increased insulin, HOMA-IR and postprandial insulin levels (p = 0.054, p = 0.056 and p = 0.095 respectively). An increase in expression of inflammation-related gene sets in adipose tissue was observed after the herbal intervention compared to placebo. Urine metabolomic analysis did not reveal a correlation of the presence of specific plant metabolites with "health markers". Our findings suggest that there is no substantiating evidence to claim that four weeks' use of the Ayurvedic herbal supplement Mohana Choorna beneficially affects glucose homeostasis.