Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial

Background: Recalcitrant greater trochanteric pain is increasingly recognized as an indication for surgical intervention. The arthroscopic approach has become rapidly more common than the open alternative. Hypothesis: Patients undergoing radiofrequency microdebridement (RFMD) as an adjunct to arthroscopic gluteal bursectomy (AGB) and iliotibial band release (ITBR) will experience better functional improvement than AGB and ITBR alone at 1 year. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 33 patients with failed nonoperative treatment of gluteal tendinopathy were randomly allocated to undergo AGB/ITBR or AGB/ITBR + RFMD. Full-thickness tears were excluded. The primary outcome measure was the modified Harris Hip Score (mHHS) at 52 weeks. Secondary outcome measures included the mHHS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and 12-item Short Form Health Survey (SF-12), which were evaluated at 0, 6, 12, 24, and 52 weeks. Statistical significance was defined as P < .05. Results: A total of 33 participants (33 hips; 30 female and 3 male; mean age, 58 years) were randomized; 16 patients underwent AGB/ITBR + RFMD, and 17 underwent AGB/ITBR. Participants’ functionality improved in both groups at all time intervals. The mean mHHS score improved from 57.49 ± 10.61 to 77.76 ± 18.40 ( P = .004) and from 58.98 ± 12.33 to 79.96 ± 18.86 ( P = .001) at 52 weeks in the AGB/ITBR and AGB/ITBR + RFMD groups, respectively, although there was no statistically significant difference between groups. There were no device-related adverse events. Conclusion: AGB/ITBR led to significant improvements in patients with recalcitrant gluteal tendinopathy. In this small RCT, the addition of RFMD showed no additional benefit to AGB/ITBR but provided a safe adjunct for the surgical management of recalcitrant gluteal tendinopathy. Registration: NCT01562366 ( ClinicalTrials.gov identifier).

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Does Capsular Closure Affect Clinical Outcomes in Hip Arthroscopy? A Prospective Randomized Controlled Trial

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120963110 ◽

2021 ◽

Vol 9 (5) ◽

pp. 232596712096311

Author(s):

Etan P. Sugarman ◽

Michael E. Birns ◽

Matthew Fishman ◽

Deepan N. Patel ◽

Laura Goldsmith ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Clinical Outcomes ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Labral Repair ◽

Harris Hip Score ◽

Secondary Outcome ◽

Randomized Controlled ◽

Outcome Score ◽

Significant Difference

Background: There is increasing concern of iatrogenic hip instability after capsulotomy during surgery. Greater emphasis is now being placed on capsular closure during surgery. There are no prospective studies that address whether capsular closure has any effect on outcomes. Purpose/Hypothesis: The purpose of this study was to evaluate patient outcomes after interportal capsulotomy repair compared with no repair. We hypothesized that restoration of normal capsular anatomy with interportal repair will achieve clinical outcomes similar to those for no repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Adult patients with femoral acetabular impingement indicated for hip arthroscopy were randomized into either the capsular repair (CR) or the no repair (NR) groups. All patients underwent standard hip arthroscopy with labral repair with or without CAM/pincer lesion resection. Clinical outcomes were measured via the Hip Outcome Score–Activities of Daily Living (HOS-ADL) subscale, Hip Outcome Score–Sport Specific (HOS-SS) subscale, modified Harris Hip Score (mHHS), visual analog scale for pain, International Hip Outcome Tool, and Veterans RAND 12-Item Health Survey (VR-12). Results: A total of 54 patients (56 hips) were included (26 men and 30 women) with a mean age of 33 years. The HOS-ADL score significantly improved at 2 years in both the NR group (from 68.1 ± 20.5 to 88.6 ± 20.0; P < .001) and the CR group (from 59.2 ± 18.8 to 91.7 ± 12.3; P < .001). The HOS-SS score also significantly improved in both the NR group (from 41.1 ± 25.8 to 84.1 ± 21.9; P < .001) and the CR group (from 32.7 ± 23.7 to 77.7 ± 23.0; P < .001). Improvement was noted for all secondary outcome measures; however, there was no significant difference between the groups at any time point. Between 1 and 2 years, the NR group showed significant worsening on the HOS-ADL (–1.21 ± 5.09 vs 4.28 ± 7.91; P = .044), mHHS (1.08 ± 10.04 vs 10.12 ± 11.76; P = .042), and VR-12 Physical (–2.15 ± 5.52 vs 4.49 ± 7.30; P = .014) subsets compared with the CR group. Conclusion: There was significant improvement in the VR-12 Physical subscale at 2 years postoperatively in the capsular CR group compared with the NR group. Capsular closure appears to have no detrimental effect on functional outcome scores after hip arthroscopy. We recommend restoration of native anatomy if possible when performing hip arthroscopy.

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Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

International Urogynecology Journal ◽

10.1007/s00192-021-04739-5 ◽

2021 ◽

Author(s):

Kari Bø ◽

Lene Anette H. Haakstad ◽

Gøran Paulsen ◽

Anne Mette Rustaden

Keyword(s):

Randomized Controlled Trial ◽

Urinary Incontinence ◽

Strength Training ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Sum Score ◽

New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial

10.21203/rs.2.14018/v2 ◽

2020 ◽

Author(s):

Shanshan Li ◽

Qing Zhang ◽

Xuan Yin ◽

Hongyu Yue ◽

Wei Zhang ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Postoperative Pain ◽

Endoscopic Surgery ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

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Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17134649 ◽

2020 ◽

Vol 17 (13) ◽

pp. 4649

Author(s):

Michele Nieri ◽

Veronica Giuntini ◽

Umberto Pagliaro ◽

Monica Giani ◽

Lorenzo Franchi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Dental Plaque ◽

Controlled Trial ◽

Secondary Outcome ◽

Outcome Variable ◽

Plaque Score ◽

Plaque Removal ◽

Randomized Controlled ◽

Significant Difference ◽

Electric Toothbrush

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.

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Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

The American Journal of Sports Medicine ◽

10.1177/0363546519826969 ◽

2019 ◽

Vol 47 (5) ◽

pp. 1130-1137 ◽

Cited By ~ 17

Author(s):

Jane Fitzpatrick ◽

Max K. Bulsara ◽

John O’Donnell ◽

Ming Hao Zheng

Keyword(s):

Randomized Controlled Trial ◽

Ultrasound Guidance ◽

Platelet Rich Plasma ◽

Corticosteroid Injection ◽

Controlled Trial ◽

Harris Hip Score ◽

Randomized Controlled ◽

Gluteal Tendinopathy ◽

To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

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Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽

10.3390/nu13113698 ◽

2021 ◽

Vol 13 (11) ◽

pp. 3698

Author(s):

Chang-Chun Wu ◽

Lee-Chin Wong ◽

Chia-Jui Hsu ◽

Chianne-Wen Yang ◽

Ying-Chieh Tsai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Tourette Syndrome ◽

Performance Test ◽

Controlled Trial ◽

Continuous Performance Test ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: Study protocol for a Randomized Controlled Trial

10.21203/rs.2.14018/v1 ◽

2019 ◽

Author(s):

Shanshan Li ◽

Qing Zhang ◽

Xuan Yin ◽

Hongyu Yue ◽

Wei Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Postoperative Pain ◽

Endoscopic Surgery ◽

Rating Scale ◽

Short Form ◽

Controlled Trial ◽

Secondary Outcome ◽

Randomized Controlled ◽

Electroacupuncture Treatment

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This trial protocol provides an example of clinical application for the management of postoperative pain using electroacupuncture treatment. If the electroacupuncture treatment protocol confirms that this treatment method is effective and safe, it can be implemented as a standard of care for relieving postoperative pain in Chinese and Western medicine.

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Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03736-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Eissa Khalifa ◽

Hashem Mohammad ◽

Ameer Abdullah ◽

Mazen Abdel-Rasheed ◽

Mohammed Khairy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pregnancy Outcomes ◽

Ovarian Stimulation ◽

Controlled Trial ◽

Secondary Outcome ◽

Cost Of Treatment ◽

Randomized Controlled ◽

Significant Difference ◽

Long Protocol

Abstract Background Endometriosis affects the responsiveness to ovarian stimulation. This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment. Methods In this randomized controlled trial, 134 women with endometriosis-related infertility were randomly allocated to group A (n = 67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol), and Group B (n = 67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF. The primary outcome measure was the number of oocytes retrieved. The secondary outcome measures included the number of mature oocytes, fertilization rate, quality of life assessed by FertiQoL scores, cost of treatment, and pregnancy outcomes. Results Although there was no statistically significant difference between both groups regarding ovarian stimulation, response parameters, and pregnancy outcomes, the Dienogest group had a lower cost of treatment (2773 vs. 3664 EGP, P < 0.001), lower side effects (29.9% vs. 59.7%, P < 0.001), higher FertiQoL treatment scores (33.2 vs. 25.1, P < 0.001) and higher tolerability scores (14.1 vs. 9.4, P < 0.001 < 0.001). Conclusion Our study indicates that Dienogest is a suitable and safe substitute for GnRHa pretreatment in endometriosis patients. Trial registration NCT04500743 “Retrospectively registered on August 5, 2020”.

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Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline

The American Journal of Sports Medicine ◽

10.1177/0363546519837954 ◽

2019 ◽

Vol 47 (7) ◽

pp. 1654-1661 ◽

Cited By ~ 23

Author(s):

Alex Scott ◽

Robert F. LaPrade ◽

Kimberly G. Harmon ◽

Giuseppe Filardo ◽

Elizaveta Kon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Outcome Measures ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Patellar Tendinopathy ◽

Secondary Outcome ◽

Global Rating ◽

Ultrasound Guided ◽

Randomized Controlled ◽

Significant Difference

Background: A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. Purpose/Hypothesis: To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures—Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change—were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients’ global rating of change. Results: Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P—58 (29), 71 (20), and 80 (18); pain—4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change—4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). Conclusion: Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. Registration: NCT02116946 (ClinicalTrials.gov identifier).

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Chyawanprash for the prevention of COVID-19 infection among healthcare workers: A Randomized Controlled Trial

10.1101/2021.02.17.21251899 ◽

2021 ◽

Author(s):

Arun Gupta ◽

Amit Madan ◽

Babita Yadav ◽

Pallavi Mundada ◽

Richa Singhal ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Healthcare Workers ◽

Controlled Trial ◽

Secondary Outcome ◽

Rt Pcr ◽

Randomized Controlled ◽

Group I ◽

Significant Difference ◽

Group Ii ◽

Significant Change

AbstractBackgroundCoronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown.ObjectiveTo evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID-19 infections among frontline healthcare workers (HCWs).MethodsAn open-label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID-19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID-19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial /viral/ fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL-6 and IL-10 were the secondary outcome measures.ResultsOut of 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. In post intervention follow-up, 4 subjects in Group I and 2 subjects in Group II were COVID-19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference.ConclusionChyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID-19, clinical trial for longer duration with larger sample size is needed.Trial registrationClinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020Date of IEC approval19.5.2020

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