Randomized-controlled Clinical Study Research Articles

Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis: A randomized control clinical and biochemical Study

Effectiveness of Zinc Supplementation in management of patients with symptomatic Benign Migratory Glossitis: A randomized control clinical and biochemical Study

Evaluation of the Role of Preoperative Pharmacological Ureteral Dilatation in Ureteroscopic Stone Surgery

Abstract Background Urinary stone disease is very common, with an estimated prevalence among the general population of 2% to 3% and an estimated lifetime risk of 1 in 8 for white males and 5% to 6% for white females, with men forming stones three times as often as women. Aim of the Work To compare the effectiveness of antispasmodics (hyoscine-N- butylbromide), α-blockers (tamsulosin), placebo as control (in the form of multivitamins), as preoperative medications for ureteral dilatation prior to semirigid ureteroscopic stone surgery. Patients and Methods This prospective randomized control clinical study conducted on 90 patients admitted from Urology department, Faculty of Medicine, Ain Shams University hospitals in a period of 6 months starting from March 2022 till September 2022; they were randomized into 3 groups 30 patients per group: Group (A) received Tamsulosin 0.4 mg once daily for 7 days, Group (B) received Hyoscine-N- butylbromide 10 mg three times per day for 7 days, Group (C) received Placebo. Results The operation time and the need of double J stent insertion significantly decrease with Tasmulosin or Hyoscine-N-butylbromide versus Placebo. Operative and postoperative complications significantly decrease while using Tamsulosin or Hyoscine- N-butylbromide versus Placebo. Conclusion The administration of adjunctive alpha-blockers and/or antispasmodics prior to ureteroscopic management of lower ureteric stones seems to be associated with better advancing of the ureteroscope to access the stone, shorter procedure time, higher stone-free rate, lower incidence of intra- and postoperative complications and lesser need for postoperative analgesia.

Efficacy of Garlic Extract (Allium sativum L.) as a Therapeutic Modality of Condyloma Acuminata: A Meta-Analysis

Background: Condyloma acuminata (CA) is a sexually transmitted infection caused by human papillomavirus (HPV). Current standard treatment has limitations, so effective and safe alternative therapies are needed. Garlic (Allium sativum L.) has long been used in traditional medicine and has potential as an antiviral and antitumor agent. This study aims to evaluate the efficacy of garlic extract as a CA therapy modality through meta-analysis. Methods: A literature search was conducted on PubMed, Scopus, and Web of Science databases to identify randomized controlled clinical studies (RCTs) evaluating the efficacy of garlic extract in CA patients. Extracted data included study characteristics, interventions, sample size, clinical outcomes, and side effects. Statistical analysis was performed using Review Manager 5.4 software. Results: A total of 8 RCTs involving 542 CA patients met the inclusion criteria. Meta-analysis showed that garlic extract was significantly more effective in clearing CA lesions compared with placebo (OR 2.87; 95% CI 1.95-4.23; p < 0.00001). Garlic extract also demonstrated comparable effectiveness to standard therapies such as podophyllin and imiquimod. There was no significant difference in the incidence of side effects between the garlic extract group and the control group. Conclusion: Garlic extract is an effective and safe therapeutic modality for CA. Further studies with more robust designs are needed to confirm these findings and explore the mechanism of action of garlic extract on CA.

Timing of oral anticoagulants initiation for atrial fibrillation after acute ischemic stroke: A systematic review and meta-analysis.

There is a longstanding clinical uncertainty regarding the optimal timing of initiating oral anticoagulants (OAC) for non-valvular atrial fibrillation following acute ischemic stroke. Current international recommendations are based on expert opinions, while significant diversity among clinicians is noted in everyday practice. We conducted an updated systematic review and meta-analysis including all available randomized-controlled clinical trials (RCTs) and observational cohort studies that investigated early versus later OAC-initiation for atrial fibrillation after acute ischemic stroke. The primary outcome was defined as the composite of ischemic and hemorrhagic events and mortality at follow-up. Secondary outcomes included the components of the composite outcome (ischemic stroke recurrence, intracranial hemorrhage, major bleeding, and all-cause mortality). Pooled estimates were calculated with random-effects model. Nine studies (two RCTs and seven observational) were included comprising a total of 4946 patients with early OAC-initiation versus 4573 patients with later OAC-initiation following acute ischemic stroke. Early OAC-initiation was associated with reduced risk of the composite outcome (RR = 0.74; 95% CI:0.56-0.98; I2 = 46%) and ischemic stroke recurrence (RR = 0.64; 95% CI:0.43-0.95; I2 = 60%) compared to late OAC-initiation. Regarding safety outcomes, similar rates of intracranial hemorrhage (RR = 0.98; 95% CI:0.57-1.69; I2 = 21%), major bleeding (RR = 0.78; 95% CI:0.40-1.51; I2 = 0%), and mortality (RR = 0.94; 95% CI:0.61-1.45; I2 = 0%) were observed. There were no subgroup differences, when RCTs and observational studies were separately evaluated. Early OAC-initiation in acute ischemic stroke patients with non-valvular atrial fibrillation appears to have better efficacy and a similar safety profile compared to later OAC-initiation.

Clinical evaluation of 0.8% hyaluronic acid gel adjunctive to scaling and root planning in the treatment of chronic periodontitis in Hyderabad Sindh.

Objective: To determine the effect of hyaluronic acid as an adjuvant to root planning and scaling for the management of chronic periodontitis patients. Study Design: Prospective Randomized-controlled Clinical study. Setting: Department of Periodontology, Faculty of Dentistry Isra Dental College Hyderabad. Period: 1st July 2022 to 31st June 2023. Methods: A total of 50 diagnosed patients of chronic periodontitis and assigned into two groups according to the treatment given. Group A received Hyaluronic acid+Scaling and Root Planning whereas group B patients received Scaling and Root Planning alone. Patients were clinically evaluated before receiving treatment. Periodontal Depth (PD), Clinical Attachment level (CAL), Blood on Probe (BOP), and Plague Index (PI) were recorded at Baseline appointments, 3rd-month appointments, and 6th-month appointments after receiving treatment. The results were analyzed by SPSS version 21. Results: in both groups, significant improvement was observed in the mean value of PD, and CAL after receiving treatment, while comparing both groups, Group A patients found more significant results (<0.05) as compared to Group B. The study also found a significant reduction in BOP and PI of both groups of patients after receiving treatment but there was not any significant difference found in the mean value of BOP and PI in both groups. Conclusion: The study was conducted to determine the effectiveness of Hyaluronic acid as an adjuvant therapy that may affect chronic periodontitis along with SRP. The current study concluded hyaluronic acid gel is an effective adjuvant therapy with SRP.

Effect of Locally Delivered Spirulina Gel on the Treatment of Stage II, Grade B Periodontitis: A Randomized Control Clinical Study.

Effect of Locally Delivered Spirulina Gel on the Treatment of Stage II, Grade B Periodontitis: A Randomized Control Clinical Study.

Efficacy of ultrasound versus short wave diathermy in the treatment of chronic low back pain in patients with lumbar disk herniation: a prospective randomized control study

BackgroundLumbar disk herniation (LDH) is a cause of chronic low back pain (CLBP) treated using physical therapy (PT), including exercise and physical modalities such as ultrasound (US) and short wave diathermy (SWD). Despite the use of US and SWD, there is inconclusive evidence on their efficacy. The aim of this study was to investigate the efficacy of US and SWD in the treatment of CLBP in patients with LDH.MethodsA prospective randomized control clinical study. Individuals with radicular CLBP and LDH on magnetic resonance imaging, presenting to the Physical and Rehabilitation Medicine Department were randomized into 3 treatment groups. All participants received 10 sessions of hotpack, transcutaneous nerve stimulation (TENS) and therapeutic exercises. In addition, Group 1 received 10 sessions of therapeutic US (1 MHz, 1.5W/cm2, 10 min), Group 2 SWD (27.12 MHz, wavelength 11.06 m, induction technique, 20 min) to the lower back. Group 3 (control group) received hotpack, TENS and therapeutic exercises alone. Visual analogue scale (VAS) for LBP, Modified Oswestry Disability Index (MODI) and Short Form 36 (SF-36) were evaluated pre and post treatment and at one and three months follow up.ResultsIn all groups, VAS for LBP and MODI improved with treatment and at the one and three month follow up (p < 0.001). In Groups 1 and 2, MODI scores continued to reduce at 1 and 3 months (p < 0.001 and p = 0.012 respectively). SF-36 physical, social function and pain parameters reduced in all groups (p < 0.05). Role limitation due to physical and emotional problems, emotional well-being, vitality and mental health improved in Groups 1 and 2 (p < 0.05).ConclusionsDeep heating agents can be used as part of the physical therapy for CLBP in those with LDH with positive mid-term effects.Trial registrationNCT03835182, 02/04/2019.

FRI607 SGLT2 Inhibition Improves Muscle Oxidative Capacity And Its Relationship With Cardiac Performance In Patients With T2D And Heart Failure

Abstract Disclosure: Y. Qin: None. N.D. Sanchez: None. A.J. Moody: None. F.M. Acosta: None. S. Neppala: None. M. Brown: None. H. Honka: None. B. Todd: None. L.A. Cruz Moreno: None. A.R. Stepanenko: None. S.E. Espinoza: None. N. Musi: None. C. Triplitt: None. G. Clarke: None. E. Cersosimo: None. R.A. DeFronzo: None. C. Solis-Herrera: None. Cardioprotective benefits of SGLT2 inhibitors (SGLT2i) have been largely thought to be coupled to a physiologic increase in plasma ketones, with much interest in the role of adaptive changes in cardiac fuel source in subjects with T2D and HF. Given the changes in the global dynamics of bioenergetics with SGLT2i, and the proven pleiotropic effects of ketone bodies, suggest that, in addition to their cardioprotective function, SGLT2i may influence other organ systems. In particular, how skeletal muscle (SkM), or cardiopulmonary function, respond to these global bioenergetics changes remains largely unknown. A pilot randomized-controlled clinical study was designed to examine the effects of SGLT2i on SkM bioenergetics (31P MRS), &amp; cardiopulmonary function (CPET), and its association with left ventricular cardiac function (MRI). Six subjects (Age=59±2.6, BMI=33.3±1.1, A1c=7.1±0.3) with T2D and HF (&amp;lt;50%) were randomized empagliflozin 25mg/day (SGLT2i) vs. placebo (control) in a 2:1 fashion for 12 weeks. Imaging and clinical evaluations were performed pre- and post-intervention. The SGLT2i group improved EF (28.7 vs. 38.8, p=0.1). SkM 31P MRS at rest, measuring the relative intracellular concentrations of high-energy metabolites of phospholipid breakdown, reduced with SGLT2i, suggesting better energy utilization by the SkM. 31P MRS-after exercise, showed significant improvements in SkM oxidative capacity (KPCR*[PCr], 0.6 to 0.8, p=0.03), with SGLT2i.During CPET testing, the ventilatory anaerobic threshold (VT), with SGLT2i, showed a significant (p=0.05) increase in VT time, suggesting an increase in the time in aerobiosis in these subjects. The minute ventilation-to-carbon dioxide output slope (a strong predictor of cardiopulmonary complications/death) was improved in the SGLT2i group vs. placebo, which could be associated with the CV benefit observed with these agents. Additionally, patient self-reported outcomes (Promis) showed a trend of improvement in the SGLT2i group. In summary, we demonstrate novel and exciting preliminary findings that in patients with T2D &amp; HF, SGLT2i-associated benefits are not isolated to the heart and may also expand to the SkM, including improved oxidative capacity, energy utilization, and SkM recovery post-exercise. With improvements in HF prognostic markers and patient self-reported outcomes. These original findings may represent novel mechanisms contributing to the cardiac benefits of SGLT2i. Presentation: Friday, June 16, 2023

Articaine versus Lidocaine in only buccal infiltration anesthesia for the extraction of mandibular anterior teeth. A prospective split-mouth randomized-controlled clinical study

ObjectiveTo investigate the effectiveness of a single labial infiltration of 4% articaine versus 2% lidocaine for the extraction of mandibular anterior teeth without an additional lingual injection.Patients and methodsA prospective, randomized-controlled, split-mouth clinical study was implemented. Healthy adult patients seeking bilateral extraction of mandibular anterior teeth were included in this study. Teeth extractions were randomly assigned to two equal groups, where one mandibular anterior tooth was extracted using a solitary labial infiltration of either 4% articaine (the study group) or 2% lidocaine (the control group). After 14 days, the other mandibular anterior tooth was extracted using the other local anesthetic agent. The selection of the anesthetic agent injected in the first session was done in a randomized fashion. After 5 min of local anesthetic injection, the tooth was extracted, and each patient was asked to record the intensity of the extraction pain using the Visual Analogue Scale (VAS).ResultsThirty-one patients were included in the study. The efficacy of a single labial injection for mandibular anterior teeth extraction was established by the fact that none of the patients in the study or control group required re-administration of local anesthesia. The mean VAS for pain control during tooth extraction was 1.16 ± 0.93 for the articaine group and 1.71 ± 0.90 for the lidocaine group. The pain score showed a statistically significant decrease in the articaine group compared to that in the lidocaine group (P = 0.017).ConclusionAlthough the anesthetic effects of only buccal infiltration of 4% articaine and 2% lidocaine for extraction of mandibular anterior teeth were comparable, the use of 4% articaine would have more effective and predictable outcomes.ClinicalTrials.org(ID: NCT05223075) 3/2/2022.

The Effect of Lactoferrin Supplementation on Iron level and Haematological Parameters after Sleeve Gastrectomy

Abstract Background Sleeve gastrectomy (SG) is one of the most effective bariatric surgery methods of treatment for obesity. It can cause nutritional deficiencies and lead to anemia at the same time. Aim and objectives To evaluate the effect of lactoferrin supplementation on iron level and haematological parameters after three months of supplementations for sleeve gastrectomy patients. Subjects and Methods This study is a randomized control clinical study, Forty patients after sleeve gastrectomy divided into two groups as follows: (Group 1): 20 cases received ferrous sulphate capsule once daily for 3 consecutive months, (Group 2): 20 cases received lactoferrin sachet twice daily for 3 consecutive months with ferrous sulfate capsule once daily. Result There is a significant increase in hemoglobin, HCT, and RBCs after 3-months follow up on ferrous sulfate supplementation. Meanwhile, there is a significant decrease in serum ferritin after 3 months follow up. However, the improvement in hematological parameters was more significant in the group of lactoferrin with ferrous sulfate. Conclusion Oral lactoferrin was better tolerated and more acceptable in combination with oral iron with higher increase in hematological parameters when compared to oral iron therapy alone over three-months treatment.

Comparing the Efficacy and Safety of Treatment with Fixed Dose of Tadalafil Monotherapy versus Its Combination with Silodosin in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

Background Benign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostatic transition zone. Aim of the Work To assess the efficacy and safety of fixed-dose of Tadalafil monotherapy versus its combination with Silodosin in treatment of BPH patient and erectile dysfunction (ED) by comparing IPSS score, PVR, Q max and The international Index of Erectile Function (IIEF questionnaire). Methodology This prospective randomized control clinical study was conducted at tertiary care hospital at Ain Shams University hospitals from June 2021 till January 2022 and performed on total 60 men patients which were 45 years old or older with a history of LUTS secondary to BPH of at least 6 months. Results Our study results revealed that there was no statistically significant difference found between the studied groups regarding IPSS and Q-max at baseline while there was statistically significant difference found in IPSS and Q-max at 1 month, 2 months and 3 months, with statistically significant decrease in IPSS and significant increase in Q-max through follow-up from baseline in each group. Conclusion This analysis suggested that the combination-therapy of tadalafil and Silodosin was more effective than tadalafil alone in improving subjective LUTS, but there was no significant improvement in sexual function.

Antioxidant supplementation during treatment of outpatient dogs with parvovirus enteritis ameliorates oxidative stress and attenuates intestinal injury: A randomized controlled trial

A prospective randomized controlled clinical study was conducted to determine whether antioxidant supplementation as an adjunct therapy alters hemogram, oxidative stress, serum intestinal fatty acid binding protein-2 (IFABP-2) level, fecal viral load, clinical score (CS) and survivability in outpatient canine parvovirus enteritis (CPVE) dogs. The dogs with CPVE were randomized to one of the five treatment groups: supportive treatment (ST) alone, ST with N-acetylcysteine (ST+NAC), resveratrol (ST+RES), coenzyme Q10 (ST+CoQ10) or ascorbic acid (ST+AA). The primary outcome measures were reduction of CS and fecal HA titre, and enhancement of survivability. Secondary outcome measures were reduction of oxidative stress indices and IFABP-2 level from day 0 to day 7. The mean CS and HA titre were significantly (P < 0.05) decreased from day 0 to 7 in ST and all antioxidant groups. The supplementations of NAC, RES and AA along with ST markedly (P < 0.05) reduced the concentrations of malondialdehyde, nitric oxide and IFABP-2 on day 7 as compared to ST alone. Additionally, NAC and RES supplementations markedly (P < 0.05) improved the total leukocyte count and neutrophil count in CPVE-affected dogs. NAC and RES could serve as better antioxidants for the amelioration of oxidative stress in CPVE but, the antioxidants did not confer any additional benefits in reduction of CS, fecal HA tire, or survivability when compared with ST alone.

Fabry Disease: Current and Novel Therapeutic Strategies. A Narrative Review.

Fabry disease (FD) is an inherited lysosomal storage disorder, leading to multisystemic manifestations and causing significant morbidity and mortality. The aim of this narrative review is to present the current and novel therapeutic strategies in FD, including symptomatic and specific treatment options. A systematic literature search was conducted to identify relevant studies, including completed and ongoing randomized-controlled clinical trials (RCTs), prospective or retrospective cohort studies, case series and case reports that provided clinical data regarding FD treatment. A multidisciplinary symptomatic treatment is recommended for FD patients, personalized according to disease manifestations and their severity. During the last two decades, FD-specific treatments, including two enzyme-replacement-therapies (agalsidase alfa and agalsidase beta) and chaperone treatment with migalastat have been approved for use and allowed for symptoms' stabilization or even disease burden reduction. More therapeutic agents are currently under investigation. Substrate reduction therapies, including lucerastat and venglustat, have shown promising results in RCTs and may be used either as monotherapy or as complementary therapy to established enzymereplacement- therapies. More stable enzyme-replacement-therapy molecules that are associated with less adverse events and lower likelihood of neutralizing antibodies formation have also been developed. Ex-vivo and in-vivo gene therapy is being tested in animal models and pilot human clinical trials, with preliminary results showing a favorable safety and efficacy profile. The therapeutic landscape in FD appears to be actively expanding with more treatment options expected to become available in the near future, allowing for a more personalized approach in FD patients.

Single Blind Randomized Control Clinical Study to Assess the Effect of Cow-Ghee On Lipid Profile and Blood Glucose in Healthy Volunteers

Ayurveda consider cow ghee as healthiest source of dietary fat and have rejuvenating property, improves memory and strengthens nervous, eyes and protects the body from various diseases by balancing all three Doshas (Vata, Pitta and Kaph) and advocates it’s use in daily diet to maintain health. Though, today concept of healthy eating has become synonym to avoid ghee. Aim: To assess the efficacy of Cow Ghee on Lipid Profile and Blood Sugar levels in Healthy Volunteers. Materials and methods: This was a Single blind randomized control clinical study. 60 healthy volunteers (30 in each group) between the age group 25-45 years were randomly selected. FBS was assessed based on WHO Guideline and Complete lipid profile was assessed based on ATP III Guideline. Statistical analysis used: result was assessed using Paired and unpaired t test with the help of Graph Pad InStat-3 software. Results: The slight increase in FBS, TC, TGs, VLDL, and HDL was recorded with mean difference 2.054, 2.91 (p = 0.4376), 21.568 (p = 0.0024), 4.141 (p = 0.0039), and 2.068 (p=0.0483) respectively compare to mean difference 10.260, 5.835 (p=0.2348), 16.88 (p=0.0297), 3.39 (p = 0.0274), and no change in HDL in placebo control group. While decrease in LDL by mean difference 3.291 (p = 0.3786) was recorded in cow ghee group compare to increase in mean difference 1.497 (p = 0.7844) in placebo control group. Conclusion: study reveals no adverse effect of consumption of 15-gram cow ghee daily for 45 days on lipids and FBS.

The effect of whole-body vibration on spasticity in post-stroke hemiplegia: A prospective, randomized-controlled study.

This study aims to investigate whether whole-body vibration (WBV) has an anti-spastic effect on the ankle plantar flexors. This single-blind, prospective, randomized-controlled clinical study included a total of 48 patients with chronic stroke (33 males, 15 females; mean age: 60.7±10.9 years; range, 25 to 80 years) between May 2019 and February 2020. They were randomized into two groups: WBV group (n=24) and sham WBV group (n=24). A training program of 12 sessions (three days a week for four weeks) was applied regularly in both groups. The spasticity degree of the plantar flexors was evaluated by using both a subjective assessment method (modified Ashworth scale [MAS]) and several objective assessment methods (Hmax/Mmax, homosynaptic post-activation depression [HPAD], and torque) before and after the training program. There were no significant changes in the torque values, Hmax/Mmax, and HPAD level after the training program in both groups (p>0.05). However, the MAS score in the WBV group significantly decreased (-9.0%), but no change in the control group was observed (0.7%) (p=0.027, effect size = 0.32). The objective assessment methods for spasticity show that WBV has no anti-spastic effect.

A time-restricted feeding intervention in children and adolescents with obesity: The TRansForm study protocol

[www.ClinicalTrials.gov], identifier [NCT05174871].

Early Anticoagulation in Patients with Acute Ischemic Stroke Due to Atrial Fibrillation: A Systematic Review and Meta-Analysis.

Introduction: There is uncertainty regarding the optimal timing for initiation of oral anticoagulation in patients with acute ischemic stroke (AIS) due to atrial fibrillation (AF). Methods: We performed a systematic review and meta-analysis of randomized-controlled clinical trials (RCTs) and prospective observational studies to assess the efficacy and safety of early anticoagulation in AF-related AIS (within 1 week versus 2 weeks). A second comparison was performed assessing the efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin-K antagonists (VKAs) in the two early time windows. The outcomes of interest were IS recurrence, all-cause mortality, symptomatic intracerebral haemorrhage (sICH) and any ICH. Results: Eight eligible studies (6 observational, 2 RCTs) were identified, including 5616 patients with AF-related AIS who received early anticoagulation. Patients that received anticoagulants within the first week after index stroke had similar rate of recurrent IS, sICH and all-cause mortality compared to patients that received anticoagulation within two weeks (test for subgroup differences p = 0.1677; p = 0.8941; and p = 0.7786, respectively). When DOACs were compared to VKAs, there was a significant decline of IS recurrence in DOAC-treated patients compared to VKAs (RR: 0.65; 95%CI: 0.52–0.82), which was evident in both time windows of treatment initiation. DOACs were also associated with lower likelihood of sICH and all-cause mortality. Conclusions: Early initiation of anticoagulation within the first week may have a similar efficacy and safety profile compared to later anticoagulation (within two weeks), while DOACs seem more effective in terms of IS recurrence and survival compared to VKAs.

Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study

BackgroundChildhood undernutrition is a major public health concern that needs special attention to achieve 2025 global nutrition targets. Moderate acute malnutrition (MAM), manifest as wasting (low weight-for-height), affects 33 million children under 5, yet there are currently no global guidelines for its treatment. We recently performed a randomized-controlled clinical study of a microbiota-directed complementary food formulation (MDCF-2) in 12-18-month-old Bangladeshi children with MAM. The results revealed that MDCF-2, freshly prepared each day, produced a significantly greater improvement in ponderal growth than a standard ready-to-use supplementary food (RUSF), an effect that is associated with repair of the disrupted gut microbial community development that occurs in children with MAM. To test the generalizability of these results in acutely malnourished children at other sites, there is a pressing need for a packaged, shelf-stable, organoleptically-acceptable formulation that is bioequivalent to MDCF-2. This report describes the protocol for a clinical study to evaluate candidate formulations designed to meet these criteria.MethodsA randomized single-blind study will be conducted in 8-12-month-old Bangladeshi children with MAM to compare the efficacy of alternative shelf-stable MDCF prototypes versus the current MDCF-2 formulation that is produced fresh each day. V4-16S rDNA amplicon and shotgun sequencing datasets will be generated from faecal DNA samples collected from each child enrolled in each group prior to, during, and after treatment to determine the abundances of MDCF-2-responsive bacterial taxa. Efficacy will be assessed by quantifying the change in representation of MDCF-2-responsive gut bacterial taxa after 4-weeks of treatment with freshly prepared MDCF-2 compared to their changes in abundance after treatment with the prototype MDCFs. Equivalence will be defined as the absence of a statistically significant difference, after 4-weeks of treatment, in the representation of faecal bacterial taxa associated with the response to MDCF-2 in participants receiving a test MDCF.DiscussionThis trial aims to establish acceptability and equivalence with respect to microbiota repair, of scalable, shelf-stable formulations of MDCF-2 in 8-12-month-old Bangladeshi children with moderate acute malnutrition.Trial registrationClinicalTrials.gov (NCT05094024). The trial has been registered before starting enrolment on 23 October 2021.

Comparative Study of Efficacy of Jatamansi (Nardostachys jatamansi DC) and Imipramine in Generalized Anxiety Disorder (G.A.D.): A Randomized Controlled Double Blind Clinical Trial

Background: Onset of G.A.D. is related with bigger excessiveness and uncontrolled worry, along with more chronic course and more severe life mutilation.Individuals suffering from G.A.D. are at high risk of bothered mental health, social functioning, and overall physical &amp;mental well being. Limited long-term efficacy of anxiolytic drugs has shown by clinical trials but drowsiness, dependency, impaired cognition and memory and sexual dysfunction like loss of libido are common adverse side effects of these drugs. Nardostachys jatamansi is a reputed Ayurvedic herb useful for treatment of various disorders mainly central nervous disorders. Various preclinical and clinical studies had proven anxiolytic activity of Jatamansi. Hence present study is planned to assess effects of Jatamansiin Generalized Anxiety Disorder.&#x0D; Materials and Methods: Presentdouble-blind randomized control clinical study involves two groups with 38 subjects each. Group A (Study Group) will be treated with administration of Tab. Jatamansi in the dose of 1000 mg B.D. orally with water. Group B (Control Group)will betreated with administration of Tab. Imipramine 75 mg H.S. orallyfor 60 days. Assessment parameter will be anxiety score based on symptoms of Generalized Anxiety Disorder. H.A.M.-A. Scale, G.A.D. – 7 Scale, Manas Bhava and Oxidative Stress. Primary outcome of study is improvement in the sign and symptoms of anxiety with reduction in anxiety scale score.

A comparative study between the effect of Aminophylline, Neostigmine and Gabapentin on prevention of post dural puncture headache after cesarean section

Abstract Objectives Post dural puncture headache (PDPH), since it is first described by August Bier in 1898, remains a common complication in spinal anesthesia (SA). Many pharmacological agents are suggested for PDPH management as acetaminophen, caffeine, non-steroidal antiinflammatory drugs, corticosteroids, and sumatriptan. Aim The aim of this study is to compare between the prophylactic effect of each of; aminophylline, gabapentin, and neostigmine added to atropine on the occurrence of PDPH after caesarean section (CS) under SA. Subjects and Methods This prospective randomized controlled clinical study was carried out 75 pregnant female patients 20-40 y, 60-100 kg. ASA physical status II undergoing elective CS. Patients were randomly divided into 3 groups (25 patients in each); group A: received 250 mg aminophylline IV immediately after delivery of the infant, group B: received IV neostigmine 20 µg/kg added to atropine 10 µg/kg immediately after delivery of the infant and group C: received 3 capsules gabapentin 300 mg; the 1st before SA by 2 h with sip of water, the 2nd after CS by 6 h and the 3rd after 14 h from CS. Results The incidence of PDPH was lower in group A (8% vs 40% in group B and 24% in group C. The onset of PDPH was significantly delayed in group C than group A and in group C than B, but insignificant between group A and B. The duration of PDPH and total dose of analgesic requirement was significantly lower in group A than group B and C and in group B than C. Heart rate (HR) showed significant increase in group A (post aminophylline than pre) only. HR in the other groups and mean arterial blood pressure showed insignificant difference among the three groups (between pre and post administration of drugs). As regards VAS, there was no significant difference in the three groups at 3 h. There was significant difference among the three groups at 6, 12, 24, 36, 48 and 72 h. (between group A &amp; B from 24h up to 72h, between group A &amp; C from 6 up to 72h and between group B &amp; C at 6 h only (delayed onset with neostigmine)). Side effects were minimal and tolerable. Conclusion Aminophylline reduced the incidence and duration of PDPH after CS under SA more than gabapentin and neostigmine with less analgesic requirement and minimal side effects. Also, neostigmine was superior than gabapentin in delaying the onset and decreasing the duration of PDPH.