Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

Abstract Introduction Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India’s Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. Methods A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. Results Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. Conclusion KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. Trial registration Clinical Trial Registry of India CTRI2020/05/025215. Registered on 16 May 2020

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AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

10.31219/osf.io/xyuas ◽

2021 ◽

Author(s):

Harbans Singh ◽

Sumit Shrivastva ◽

Babita Yadav ◽

Amit Kumar Rai ◽

Sophia Jameela ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Inflammatory Markers ◽

Standard Care ◽

Controlled Trial ◽

Control Group ◽

Rt Pcr ◽

Open Label ◽

Clinical Recovery ◽

Randomized Controlled ◽

Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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Effectiveness of Antipyretic with Tepid Sponging Versus Antipyretic Alone in Febrile Children: A Randomized Controlled Trial

Journal of Nepal Paediatric Society ◽

10.3126/jnps.v37i2.16879 ◽

2018 ◽

Vol 37 (2) ◽

pp. 129-133

Author(s):

Chetak Kadbasal Basavaraj ◽

Shyamala Gowri Pocha ◽

Ravi Mandyam Dhati

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Study Group ◽

Axillary Temperature ◽

Medical College ◽

Randomized Controlled ◽

Significant Difference

Introduction: Fever is the most common presenting complain for which children are brought to the paediatrician.Physical methods are widely used in treating febrile children, tepid sponging being commonly practiced in hospitals along with antipyretics. The objectives of this study were to compare the effectiveness of tepid sponging and antipyretic drug versus antipyretic drug alone in febrile children.Material and Methods: This was a Randomized controlled trial done in JSS Medical College and Hospital. All children under the age of 6 months to 12 years, admitted with axillary temperature of >99oF were included in the study. A total of 500 children were included over two years study period. Children with recorded axillary temperature of >990F were randomized into control and study group by computer generated randomisation. Children in the control group received only paracetamol (15mg/kg) at 5 minutes and combined group received paracetamol and tepid sponging at five minutes. Axillary temperature was monitored every 15 minutes for a period of 2 hours in both the groups.Results: There is no significant difference in reduction of temperature between the two groups by the end of two hours. Children in combined group had a higher level of discomfort than those in only antipyretic group.Conclusion: Tepid sponging does not add to the efficacy of paracetamol in antipyresis and that addition of tepid sponging to antipyretic, results in additional discomfort for the child. This study, therefore, endorses the view that antipyretic alone without tepid sponging should be the modality of therapy in children with fever.

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A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20201791 ◽

2020 ◽

Vol 9 (5) ◽

pp. 1976

Author(s):

Rahul Kirtania ◽

Jayita Pal ◽

Sisir Biswas ◽

Aditi Aich

Keyword(s):

Randomized Controlled Trial ◽

Blood Loss ◽

Controlled Trial ◽

Active Management ◽

Control Group ◽

Care Hospital ◽

Normal Delivery ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

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The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Maryam Montazeri ◽

Khalil Esmaeilpour ◽

Sakineh Mohammad-Alizadeh-Charandabi ◽

Sevda Golizadeh ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Block Design ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Writing Therapy ◽

Randomized Block Design ◽

Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

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A Randomized Controlled Trial on the Effectiveness of Court-Type Traditional Thai Massage versus Amitriptyline in Patients with Chronic Tension-Type Headache

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/930175 ◽

2015 ◽

Vol 2015 ◽

pp. 1-12 ◽

Cited By ~ 5

Author(s):

Peerada Damapong ◽

Naowarat Kanchanakhan ◽

Wichai Eungpinichpong ◽

Prasobsook Putthapitak ◽

Pongmada Damapong

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Alternative Therapy ◽

Pressure Pain Threshold ◽

Tension Type Headache ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Tissue Hardness ◽

Tension Type Headaches

This study aimed to evaluate the effectiveness of the court-type traditional Thai massage (CTTM) to treat patients with chronic tension-type headaches (CTTHs) comparing with amitriptyline taking. A randomized controlled trial was conducted. Sixty patients diagnosed with CTTH were equally divided into a treatment and a control group. The treatment group received a 45-minute course of CTTM twice per week lasting 4 weeks while the control group was prescribed 25 mg of amitriptyline once a day before bedtime lasting 4 weeks. Outcome measures were evaluated in week 2, week 4 and followed up in week 6 consisting of visual analog scale (VAS), tissue hardness, pressure pain threshold (PPT), and heart rate variability (HRV). The results demonstrated a significant decrease in VAS pain intensity for the CTTM group at different assessment time points while a significant difference occurred in within-group and between-group comparison (P< 0.05) for each evaluated measure. Moreover, the tissue hardness of the CTTM group was significantly lower than the control group at week 4 (P< 0.05). The PPT and HRV of the CTTM group were significantly increased (P< 0.05). CTTM could be an alternative therapy for treatment of patients with CTTHs.

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The effectiveness of preoperative individual information on reducing anxiety and pain after hysterectomy: A randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n1p67 ◽

2019 ◽

Vol 10 (1) ◽

pp. 67

Author(s):

Hrønn Thorn ◽

Lisbeth Uhrenfeldt

Keyword(s):

Randomized Controlled Trial ◽

Postoperative Pain ◽

Controlled Trial ◽

Anxiety Level ◽

Preoperative Anxiety ◽

Control Group ◽

Study Group ◽

Randomized Controlled ◽

Significant Difference ◽

Individual Information

Background and objective: Preoperative anxiety among gynecological patients is well-known and has a direct correlation with postoperative pain. By minimizing preoperative anxiety, the level of postoperative pain may decrease. The purpose of this study was to evaluate the effect of preoperative structured information and dialogue on patients' anxiety and postoperative pain.Methods: A single-center non-blinded randomized controlled trial. Forty-six women scheduled for hysterectomy were allocated either to the study group or the control group. The study group was given individual information at a preoperative consultation while the control group was given information at admittance. The main outcome was anxiety level and postoperative pain.Results: Forty participants (study group = 20; control group = 20) were analyzed. No statistically significant difference was found in anxiety level within the first 24 h postoperatively or in postoperative pain within four weeks between the groups.Conclusions: Preoperative individual information and dialogue did not result in significant effects in reducing anxiety level nor did it result in lower postoperative pain score.

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Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects

Neurosurgery ◽

10.1227/neu.0b013e3182284aca ◽

2011 ◽

Vol 69 (5) ◽

pp. 1093-1104 ◽

Cited By ~ 33

Author(s):

Charles L. Rosen ◽

Gary K. Steinberg ◽

Franco DeMonte ◽

Johnny B. Delashaw ◽

Stephen B. Lewis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Fluid Collection ◽

Infectious Agent ◽

Study Endpoint ◽

Primary Study ◽

Control Group ◽

Randomized Controlled ◽

Dural Closure ◽

Significant Difference

Abstract BACKGROUND After intradural cranial surgery, a dural substitute is often required for dural closure. Although preferred, limitations of autograft include local availability and additional surgical site morbidity. Thus, allografts, xenografts, and synthetics are frequently used. OBJECTIVE To report 6-month results of a randomized, controlled trial of a biosynthesized cellulose (BSC) composed duraplasty device compared with commercially available dural replacements. METHODS A total of 99 patients (62 BSC; 37 control) were treated on protocol, using a 2:1 (BSC:control) blocked randomization schedule. Physical examinations were performed pre- and postoperatively within 10 days and at 1, 3, and 6 months. Magnetic resonance imaging was performed preoperatively and at 6 months. The primary study endpoint was the absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and the absence of cerebrospinal fluid fistula at 6 months. RESULTS At 6 months, the primary hypothesis, noninferiority of the BSC implant compared with the control group, was confirmed (P = .0206). Overall success was achieved by 96.6% of BSC and 97.1% of control patients. No significant difference was revealed between treatment groups for surgical site infection (P = 1.0000) or wound healing assessment (P ≥ .3685) outcomes, or radiologic endpoints (P ≥ .4061). Device strength and seal quality favored BSC. CONCLUSION This randomized, controlled trial establishes BSC as noninferior to commercially available dural replacement devices. BSC offers a hypothetical advantage concerning prion and other infectious agent exposure; superior handling qualities are evident. Longer term data are necessary to identify limitations of BSC and its potential equivalence to the gold standard of pericranium.

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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