scholarly journals Clinical Studies on the Efficacy and Safety of Padma 28, a Complex Herbal Formulation from Tibetan Medicine: An Overview

2013 ◽  
Vol 20 (s2) ◽  
pp. 25-30 ◽  
Author(s):  
Cecile Vennos ◽  
Jörg Melzer ◽  
Reinhard Saller
Keyword(s):  
Clinical Studies ◽  
Tibetan Medicine ◽  
Efficacy And Safety ◽  
Herbal Formulation ◽  
Padma 28

Effects of the Tibetan herbal preparation PADMA 28 on blood lipids and lipid oxidisability in subjects with mild hypercholesterolaemia

VASA ◽  
2005 ◽  
Vol 34 (1) ◽  
pp. 11-17 ◽  
Author(s):  
Brunner-La Rocca ◽  
Schindler ◽  
Schlumpf ◽  
Saller ◽  
Suter
Keyword(s):  
Endothelial Dysfunction ◽  
Blood Lipids ◽  
Ex Vivo ◽  
Hdl Cholesterol ◽  
Blood Lipid ◽  
Tibetan Medicine ◽  
Double Blind ◽  
Intraarterial Infusion ◽  
Padma 28

Background: Previous studies showed an anti-atherosclerotic effect of PADMA 28, an herbal formula based on Tibetan medicine. As the mechanisms of action are not fully understood, we investigated whether PADMA 28 may lower blood lipids and lipid oxidisability, and affect early endothelial dysfunction. Patients and methods: Sixty otherwise healthy subjects with total cholesterol ≥5.2 mmol/l and < 8.0 mmol/l were randomly assigned to placebo or PADMA 28, 3 x 2 capsules daily, for 4 weeks (double-blind). Blood lipids (total, LDL-, and HDL-cholesterol, triglycerides, Apo-lipoprotein A1 and B) and ex vivo lipid oxidisability were measured before and after treatment. In a subset of 24 subjects, endothelial function was assessed using venous occlusion plethysmography with intraarterial infusion of acetylcholine. Isolated LDL and plasma both untreated and pre-treated with PADMA 28 extract were oxidised by the radical generator AAPH. Conjugated diene formation was measured at 245 nm. Results: Blood lipids did not change during the study in both groups. In contrast to previous reports in mild hypercholesterolaemia, no endothelial dysfunction was seen and, consequently, was not influenced by therapy. Ex vivo blood lipid oxidisability was significantly reduced with PADMA 28 (area under curve: 5.29 ± 1.62 to 4.99 ± 1.46, p = 0.01), and remained unchanged in the placebo group (5.33 ± 1.88 to 5.18 ± 1.78, p > 0.1). This effect persisted one week after cessation of medication. In vitro experiments confirmed the prevention of lipid peroxidation in the presence of PADMA 28 extracts. Persistent protection was also seen for LDL isolated from PADMA 28-pretreated blood after being subjected to rigorous purification. Conclusions: This study suggests that the inhibition of blood lipid oxidisability by PADMA 28 may play a role in its anti-atherosclerotic effect.

scholarly journals Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Nut Koonrungsesomboon ◽  
Saowaros Nopnithipat ◽  
Supanimit Teekachunhatean ◽  
Natthakarn Chiranthanut ◽  
Chaichan Sangdee ◽  
...  
Keyword(s):  
Knee Pain ◽  
Controlled Trial ◽  
Common Adverse Event ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Osteoarthritis Of The Knee ◽  
Efficacy And Safety ◽  
Short Term Treatment ◽  
Double Blind ◽  
Herbal Formulation

Background. Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods. This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results. A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis. The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p = 0.748 ; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p = 0.486 ). Significant improvement was observed in all the efficacy parameters in both groups. Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p = 0.417 . Conclusions. THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee. It was shown to be noninferior to oral diclofenac in relieving knee pain. This trial is registered with ChiCTR-IPR-15007213.

scholarly journals Rectal artemisinins for malaria: a review of efficacy and safety from individual patient data in clinical studies

2008 ◽  
Vol 8 (1) ◽  
Author(s):  
Melba Gomes ◽  
Isabela Ribeiro ◽  
Marian Warsame ◽  
Harin Karunajeewa ◽  
Max Petzold
Keyword(s):  
Clinical Studies ◽  
Individual Patient Data ◽  
Patient Data ◽  
Efficacy And Safety

scholarly journals Efficacy and Safety of Iranian Poly Herbal Formulation (Compound Honey Syrup) in Pediatric Patients with Mild to Moderate Asthma: A Randomized Clinical Trial

2017 ◽  
Vol 6 (4) ◽  
pp. 291-301
Author(s):  
Saeed Sadr ◽  
Shahpar Kaveh ◽  
Rasool Choopani ◽  
Houman Bayat ◽  
Mahmoud Mosaddegh
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pediatric Asthma ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Efficacy And Safety ◽  
Asthma Control Questionnaire ◽  
Moderate Asthma ◽  
Herbal Formulation ◽  
Significant Difference

Background: Asthma is a chronic relapsing airways disease that represents a major public health problem worldwide. With the high incidence of asthma, there has been a surge in the use of complementary therapies, such as compound honey syrup in Traditional Persian Medicine, in the treatment of asthma. The aim of this study was to evaluate the efficacy and safety of Iranian poly herbal formulation (compound honey syrup) in the treatment of mild to moder­ate pediatric asthma. Materials and Methods: The study was a randomized clinical trial that was conducted on 80 patients with mild to moderate asthma assigned to two groups (n=40 for each group) for eight weeks. Control and experimental groups received classical treatment of asthma with fluticasone spray; in case of worsening of symptoms, salbutamol spray was used for short term. The experimental group also received compound honey syrup (the combina­tion of honey and an extract of the following five medicinal plants: ginger, cinnamon, saf­fron, cardamom, and galangal). Asthma Control Questionnaire (ACQ) items and total scores of ACQ were evaluated before and after treatment. Results: To this end, 72 patients complet­ed this study. There was no significant difference between the experimental and the control groups in baseline data such as age, sex, body mass index, ACQ items, and ACQ scores. Total scores and all items of ACQ, with the exception of forced expiratory volume in one second (FEV1%), were significant between groups (P<0.05). No serious adverse effects were ob­served in the two groups. Conclusions: The results of this study reveal that compound honey syrup can be a safe and effective complementary drug for the treatment of pediatric asthma [GMJ.2017;6(4):291-301] DOI: 10.22086/gmj.v6i3.884

scholarly journals COVID-19 Pandemic - A Narrative Review of the Potential Roles of Chloroquine and Hydroxychloroquine

2020 ◽  
Vol 4S;23 (8;4S) ◽  
pp. S351-S366
Author(s):  
Vanessa B. Boralli
Keyword(s):  
Adverse Effects ◽  
Cardiac Arrhythmias ◽  
Clinical Studies ◽  
Narrative Review ◽  
Efficacy And Safety ◽  
Length Of Treatment ◽  
Lack Of Information ◽  
Small Patient ◽  
High Doses

Background: Chloroquine (CQ) and hydroxychloroquine (HCQ) are old drugs used against malaria, rheumatism, inflammation in the joints, lupus, among others. These drugs showed positive results in preliminary scientific research for treatment of the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Since the studies with CQ and HCQ are initial with small patient populations, it is not yet known whether there are adverse effects from the use of CQ and HCQ for patients infected with the coronavirus. Objectives: The aim of this study was to evaluate the evidence regarding the efficacy and safety of CQ and HCQ used against viral infection caused by SARS-CoV-2. Study Design: This is a narrative review of the traditional prescriptions of CQ and HCQ efficacy and adverse effects as well as their employment for coronavirus disease 2019 (COVID-19). Setting: In vitro and clinical studies comparing the antiviral efficacy and adverse effect profile of CQ and HCQ against COVID-19 in adult patients were evaluated. Methods: A systemic search of reviews, including in vitro and clinical trial studies in English focusing on CQ and HCQ effects and adverse effects against COVID-19 in the adult patient population from PubMed was performed. It included studies reporting chloroquine and hydroxychloroquine effects and adverse effects against COVID-19. Results: A total of 42 articles published between 2004 and April 2020 were reviewed for therapeutic use of CQ and HCQ. Both these drugs showed a significant in vitro potential against coronavirus. Many studies for clinical use of CQ and HCQ showed that patients presented adverse reactions on high doses. Limitations: Clinical studies have some methodology shortcomings, such as lack of information about the treatment and small number of experimental patients, leading to a misinterpretation of the data. Besides, there are few clinical studies with a limited sample size. Moreover, most of them did not present control groups, and some patients had died during these protocols. Discussion: Despite both CQ and HCQ in vitro antiviral evidence, clinically, both drugs, either alone or combined with other medications, may increase the risk of cardiac arrhythmias, leading to cardiac arrest and sudden death. Besides, a lot of uncertainty still remains, such as starting administration period, dose prescribed, length of treatment, patients’ condition, concomitant drug use, among others. Conclusion: From the studies reviewed, it is not possible to state the precise efficacy and safety of CQ and HCQ use in the treatment of COVID-19 at any time in the course of the disease. Future studies are warranted. Key words: SARS-CoV-2; COVID-19; chloroquine; hydroxychloroquine; pandemic; coronavirus; adverse effects; side effects; cardiac arrhythmias; ocular toxicity, retinopathy; pharmacokinetic.

scholarly journals CLINICAL STUDIES ON MILD POST COVID SYNDROME WITH iWALL TABLET

2021 ◽  
Vol p5 (02) ◽  
pp. 2714-2720
Author(s):  
Naringe Yogendra Seema
Keyword(s):  
Sore Throat ◽  
Clinical Studies ◽  
Shortness Of Breath ◽  
Efficacy And Safety ◽  
The World ◽  
Entire World

COVID-19 Cases across the globe is more than 100 million. Subsets of people who have recovered from COVID-19 experience symptoms that remain even after testing negative for the virus, these set of symptoms are called Post COVID Syndrome or long COVID. Researchers all over the world are trying to deal with this disease. Ayurveda will be of great help for the entire world in dealing with this Syndrome so present study was carried out with iWALL tablet which is a polyherbal Ayurvedic formulation to see the efficacy and safety of this drug in Mild Post COVID Syndrome. In this study 25 patients with Mild Post COVID Syndrome like fatigue, myalgia, cough, sore throat and shortness of breath were treated with iWALL Tablet 750 mg two times a day for 3 month. All the data collected statistically shows significant results and study concluded that iWALL tablet is effective and safe in Mild Post COVID Syndrome.

scholarly journals Real-Life Experience of Nivolumab in Heavily Pretreated Relapsed and Refractory Classical Hodgkin Lymphoma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3008-3008 ◽  
Author(s):  
Ohad Benjamini ◽  
David Lavie ◽  
Eldad J Dann ◽  
Chava Perry ◽  
Ory Rouvio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hodgkin Lymphoma ◽  
Clinical Studies ◽  
Life Experience ◽  
Real Life ◽  
Brentuximab Vedotin ◽  
Efficacy And Safety ◽  
Classical Hodgkin Lymphoma ◽  
Post Transplantation ◽  
Heavily Pretreated

Abstract Background: The fully human IgG4 anti-PD-1 monoclonal antibody, nivolumab, has shown to be highly efficacious in relapsed and refractory (RR) classical Hodgkin lymphoma (cHL). Initial results of a single-arm nivolumab monotherapy in heavily pretreated young adults with RR cHL, previously treated with autologous hematopoetic stem cell transplantation (autoSCT) and brentuximab vedotin are promising. However, demonstrating similar results in real-life experience in patients not on Pharma clinical studies are of major clinical importance. Aim: The aim of the current study was to evaluate the efficacy and safety of nivolumab in previously heavily pretreated patients with RR cHL not on Pharma clinical studies. Methods: The records of patients with RR cHL who were treated with nivolumab in seven medical centers were reviewed. The regimen consisted of nivolumab 3 mg/kg once every 2 weeks until disease progression or unacceptable toxicity. Results: Between May 2015 and April 2016, 30 patients with RR cHL received nivolumab monotherapy. The median age was 35 years (range: 21 to 88). Patients were extremely heavily pretreated with median of 6 prior therapies (range: 3 to 11); 73% of them received ≥ 5 lines of therapy. Specifically, 29/30 (97%) received ABVD, 7/30 (23%) escBEACOPP, 20/30 (67%) gemcitabine based regimens, 30/30 (100%) brentuximab vedotin, 8/30 (27%) bendamustine, 3/30 (10%) lenalidomide, 28/30 (93%) other combinations of chemotherapy and 22/30 (73%) radiotherapy. Twenty patients (67%) previously underwent autoHSCT and 4/30 (13%) allogeneic transplantation (alloSCT), two before and two after receiving nivolumab. Median number of nivolumab doses received was 8 (range 1 to 29). Twenty three patients (77%) are still on treatment. Seven patients (23%) discontinued therapy due to disease progression 3/30 (10%), adverse events 2/30 (7%) and referral to alloSCT 2/30 (7%). Overall response rate among 25 evaluable patients was 76%, complete response (CR) - 7/25 (28%), partial response - 12/25 (48%), stable disease - 3/25 (12%) and only 3/25 (12%) progressed, one of them with cHL type of Richter's transformation. Two patients underwent alloSCT in remission following nivolumab treatment. One patient was transplanted from a matched sibling donor and the second patient from a T replete haploidentical donor with post transplantation cyclophosphamide as anti-graft versus host disease prophylaxis. Both patients are in CR, ten and three months post transplantation, respectively. The median overall survival (OS) and progression free survival (PFS) for the cohort were not reached (Figure 1). At 24 weeks the PFS was 74%. Adverse events reported in 9/30 patients (30%) were usually mild. Severe nivolumab related adverse events in 3/30 (10%) included immune related pneumonitis, myelitis and uveitis. No treatment related death occurred. Conclusions: The check point inhibitor nivolumab is a novel therapy for RR cHL patients, previously with unmet need following relapse or refractory to autoHSCT and brentuximab vedotin. Our real life experience confirms and highlights the efficacy and safety of nivolumab in very heavily pretreated young and elderly patients with cHL eligible as well as ineligible for autologous HSCT. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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