The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial
Abstract Background Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood and adolescence. A number of these patients do not respond to the current pharmacological treatments and there may also be drug side effects. This study aims to determine the effic...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06297-7 |
| _version_ | 1811253606886670336 |
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| author | Haide Golsorkhi Mostafa Qorbani Mohammad Kamalinejad Saeideh Sabbaghzadegan Mohsen Bahrami Mohammad Vafaee-Shahi Hadi Montazerlotfelahi Elham Abniki Majid Dadmehr |
| author_facet | Haide Golsorkhi Mostafa Qorbani Mohammad Kamalinejad Saeideh Sabbaghzadegan Mohsen Bahrami Mohammad Vafaee-Shahi Hadi Montazerlotfelahi Elham Abniki Majid Dadmehr |
| author_sort | Haide Golsorkhi |
| collection | DOAJ |
| description | Abstract Background Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood and adolescence. A number of these patients do not respond to the current pharmacological treatments and there may also be drug side effects. This study aims to determine the efficacy and safety of two herbal medicine products, including Rosa canina L. (RC) and a polyherbal formulation (PHF) syrup, on the clinical manifestations of ADHD in children and adolescents. Methods Ninety ADHD patients based on DSM-5 diagnostic criteria will be randomly assigned equally into three groups: (1) RC syrup + methylphenidate (MP), (2) PHF syrup + MP, and (3) placebo + MP according to the inclusion criteria (30 subjects in each group). The syrup dosage is 5cc every 8 h, and MP will have a stabilized dose for 8 weeks during the study. Moreover, Conner’s questionnaires will be completed by the teacher and parents before the intervention and then every 4 weeks. Also, the Child Symptom Inventory-fourth edition (CSI-4) and temperament questionnaires will be completed before the intervention and every 4 weeks until 2 months. Discussion This trial is the first experiment to determine the effects of RC and PHF syrups on the clinical manifestations of ADHD in children and adolescents. Our findings provide new insight into the effect of these herbal products on the clinical manifestations of ADHD. Trial registration Iranian Registry of Clinical Trials IRCT20190923044855N1 . Registered on 14 January 2020. The trial was registered at https://www.irct.ir/ . |
| first_indexed | 2024-04-12T16:53:43Z |
| format | Article |
| id | doaj.art-520cf40dd0ca4b4393153d0ffa037ca4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T16:53:43Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-520cf40dd0ca4b4393153d0ffa037ca42022-12-22T03:24:19ZengBMCTrials1745-62152022-05-012311710.1186/s13063-022-06297-7The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trialHaide Golsorkhi0Mostafa Qorbani1Mohammad Kamalinejad2Saeideh Sabbaghzadegan3Mohsen Bahrami4Mohammad Vafaee-Shahi5Hadi Montazerlotfelahi6Elham Abniki7Majid Dadmehr8Department of Traditional Medicine, Research Institute for Islamic and Complementary Medicine, Iran University of Medical SciencesNon-communicable Diseases Research Center, Alborz University of Medical SciencesDepartment of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical SciencesDepartment of Traditional Medicine, Research Institute for Islamic and Complementary Medicine, Iran University of Medical SciencesResearcher of Persian Medicine, Private clinicDepartment of Pediatrics, School of Medicine, Iran University of Medical SciencesDepartment of Pediatrics, School of Medicine, Alborz University of Medical SciencesResearcher of Clinical Psychology, Private clinicDepartment of Traditional Medicine, Research Institute for Islamic and Complementary Medicine, Iran University of Medical SciencesAbstract Background Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood and adolescence. A number of these patients do not respond to the current pharmacological treatments and there may also be drug side effects. This study aims to determine the efficacy and safety of two herbal medicine products, including Rosa canina L. (RC) and a polyherbal formulation (PHF) syrup, on the clinical manifestations of ADHD in children and adolescents. Methods Ninety ADHD patients based on DSM-5 diagnostic criteria will be randomly assigned equally into three groups: (1) RC syrup + methylphenidate (MP), (2) PHF syrup + MP, and (3) placebo + MP according to the inclusion criteria (30 subjects in each group). The syrup dosage is 5cc every 8 h, and MP will have a stabilized dose for 8 weeks during the study. Moreover, Conner’s questionnaires will be completed by the teacher and parents before the intervention and then every 4 weeks. Also, the Child Symptom Inventory-fourth edition (CSI-4) and temperament questionnaires will be completed before the intervention and every 4 weeks until 2 months. Discussion This trial is the first experiment to determine the effects of RC and PHF syrups on the clinical manifestations of ADHD in children and adolescents. Our findings provide new insight into the effect of these herbal products on the clinical manifestations of ADHD. Trial registration Iranian Registry of Clinical Trials IRCT20190923044855N1 . Registered on 14 January 2020. The trial was registered at https://www.irct.ir/ .https://doi.org/10.1186/s13063-022-06297-7Attention-deficit/hyperactivity disorderADHDComplementary and alternative medicinesHerbal medicine |
| spellingShingle | Haide Golsorkhi Mostafa Qorbani Mohammad Kamalinejad Saeideh Sabbaghzadegan Mohsen Bahrami Mohammad Vafaee-Shahi Hadi Montazerlotfelahi Elham Abniki Majid Dadmehr The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial Trials Attention-deficit/hyperactivity disorder ADHD Complementary and alternative medicines Herbal medicine |
| title | The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial |
| title_full | The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial |
| title_fullStr | The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial |
| title_full_unstemmed | The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial |
| title_short | The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial |
| title_sort | effect of rosa canina l and a polyherbal formulation syrup in patients with attention deficit hyperactivity disorder a study protocol for a multicenter randomized controlled trial |
| topic | Attention-deficit/hyperactivity disorder ADHD Complementary and alternative medicines Herbal medicine |
| url | https://doi.org/10.1186/s13063-022-06297-7 |
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