Effect of Ayurvedic Interventions on Toxemia of Pregnancy (Preeclampsia) & Fetal Outcome- A Randomized Placebo-Controlled Trial

Background: Toxemia of pregnancy also known as preeclampsia is a common clinical condition affecting 8-10% pregnancies worldwide. It has adverse outcome both for mother and fetus. The management options are mainly targeted to prevent adverse outcomes associated to premature births, such as administration of antenatal corticosteroids and magnesium sulphate infusions. Aim & Objectives: The main aim of the study was to evaluate efficacy of Ayurvedic interventions in management of toxemia and in prevention of premature delivery as well as fetal hazards due to pre-eclampsia. Methods: It was an open ended, parallel group, randomized placebo controlled clinical trial with equal allocation in both the groups. Sample size was 15 in each group. Trial group was administered Gokshura Siddha Yavagu(Green gram gruel medicated with Tribulus terrestris Linn) and Dhatryavaleha (linctus prepared with Ayurveda medicines like Phyllanthus emblica L.)while control group was treated with similar looking placebo-linctus. Results: Both ayurvedic parameters-Shotha(edema), Avil mutrata (Discolored urine) & clinical features of toxemia have shown excellent relief while control group patients either show poor or no relief when assessed by USG scan and needed further treatment with induction of labor. Conclusion: This study concludes that Ayurvedic interventions in the form of Gokshura siddha Yavagu and Dhatri Avleha can provide significant symptomatic relief (p<0.0001) in toxemia of pregnancy and can also promote normal growth and development in fetus.

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The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02631-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Alireza Amanollahi ◽

Sheikh Mohammed Shriful Islam ◽

Jenna McVicar ◽

...

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

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The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial

Nutrients ◽

10.3390/nu12051522 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1522

Author(s):

Yeek Tat Ng ◽

Sonia Chew Wen Phang ◽

Gerald Chen Jie Tan ◽

En Yng Ng ◽

Nevein Philip Botross Henien ◽

...

Keyword(s):

Vitamin E ◽

Nerve Conduction ◽

Controlled Trial ◽

Intervention Group ◽

Serum Biomarkers ◽

Control Group ◽

Controlled Clinical Trial ◽

Diabetic Patients ◽

Chronic Hyperglycemia ◽

Conduction Velocities

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.

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App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

10.2196/preprints.19624 ◽

2020 ◽

Author(s):

Stephanie Erika Bonn ◽

Mari Hult ◽

Kristina Spetz ◽

Marie Löf ◽

Ellen Andersson ◽

...

Keyword(s):

Physical Activity ◽

Bariatric Surgery ◽

Controlled Trial ◽

Intervention Group ◽

Study Participant ◽

Lifestyle Factors ◽

Lifestyle Changes ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

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A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

Addiction Science & Clinical Practice ◽

10.1186/s13722-020-00209-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

K. Sorsdahl ◽

D. J. Stein ◽

S. Pasche ◽

Y. Jacobs ◽

R. Kader ◽

...

Keyword(s):

South Africa ◽

Controlled Trial ◽

Adverse Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Brief Treatment ◽

Middle Income ◽

Methamphetamine Use ◽

Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

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Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/9329465 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Yu-yang Pang ◽

Yan Li ◽

Gang Kui ◽

Yong Tang ◽

Ming-juan Liao ◽

...

Keyword(s):

Clinical Trial ◽

Myeloproliferative Neoplasms ◽

Controlled Trial ◽

Intervention Group ◽

Complete Healing ◽

Control Group ◽

Controlled Clinical Trial ◽

Leg Ulcers ◽

Open Label ◽

Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

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“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

Clinical Rehabilitation ◽

10.1177/0269215520965054 ◽

2020 ◽

pp. 026921552096505

Author(s):

Vanessa González-Rueda ◽

Carlos López-de-Celis ◽

Elena Bueno-Gracia ◽

Jacobo Rodríguez-Sanz ◽

Albert Pérez-Bellmunt ◽

...

Keyword(s):

Neck Pain ◽

Rating Scale ◽

Controlled Trial ◽

Neck Disability Index ◽

Chronic Neck Pain ◽

Control Group ◽

Controlled Clinical Trial ◽

Primary Care Center ◽

Randomized Controlled ◽

Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

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Efficacy of Integrative Body-Mind-Spirit Group Intervention for Parents of Children With Eczema: A Randomized, Wait-List Controlled Clinical Trial

Research on Social Work Practice ◽

10.1177/1049731520905643 ◽

2020 ◽

Vol 30 (6) ◽

pp. 623-632

Author(s):

Yat-Lui Fung ◽

Hiu-Tin Leung ◽

Celia H. Y. Chan ◽

Bobo H. P. Lau ◽

Cecilia L. W. Chan

Keyword(s):

Psychosocial Intervention ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Empirical Support ◽

Well Being ◽

Control Group ◽

Controlled Clinical Trial ◽

Wait List ◽

Reducing Stress

Objectives: This randomized controlled trial evaluated the effects of a psychosocial intervention developed based on the Integrative Body-Mind-Spirit (IBMS) model that aimed to enhance the well-being of parents of children with eczema. Methods: Ninety-one families were randomly allocated to either the six-session intervention group ( n = 48) or the wait-list control group ( n = 43) and completed the randomized trial. For both groups, a range of psychosocial outcome measures were taken before the intervention (T0), postintervention (T1), and 6 weeks after the intervention (T2). Results: Relative to the control group, the intervention group was significantly improved over time in their levels of perceived stress, depression, and a number of holistic well-being measures, including nonattachment, afflictive ideation, and general vitality. Discussion: The results provided empirical support for an IBMS-informed psychosocial intervention in reducing stress and depression and enhancing well-being among parents of children with eczema.

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A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty

Scientific Reports ◽

10.1038/s41598-021-02848-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Sung-Won Choi ◽

Se-Joon Oh ◽

Yehree Kim ◽

Min Young Kwak ◽

Myung-Whan Suh ◽

...

Keyword(s):

Eustachian Tube ◽

Valsalva Maneuver ◽

Controlled Trial ◽

Pure Tone Audiometry ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Multicenter Rct ◽

Balloon Eustachian Tuboplasty

AbstractTo assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air–bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.

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Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

BIRDEM Medical Journal ◽

10.3329/birdem.v7i3.33783 ◽

2017 ◽

Vol 7 (3) ◽

pp. 216-220

Author(s):

Md Mehedi Hasan ◽

Samira Rahat Afroze ◽

Muhammad Abdur Rahim ◽

Muhammad Abdus Salam

Keyword(s):

Controlled Trial ◽

Ethical Review ◽

Control Group ◽

Controlled Clinical Trial ◽

Transurethral Resection Of Prostate ◽

Randomized Controlled ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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