Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial
Objectives: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderat...
Gespeichert in:
| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2021-08, Vol.22 (1), p.514-514, Article 514 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 514 |
|---|---|
| container_issue | 1 |
| container_start_page | 514 |
| container_title | Current controlled trials in cardiovascular medicine |
| container_volume | 22 |
| creator | Mahmoodi, Sara Yousefi, Mojtaba Sadeghi, Omid Mahmoodabadi, Ali Sadriirani, Mohammadreza Hosseinzade, Zahra Jahanbakhsh, Abdolhossein Panahande, Seyed Bahman Saeedinejad, Zaker Malekzadeh, Jan Mohamad Naghmachi, Mohsen Pourmahmoudi, Azizollah |
| description | Objectives: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.
Trial design: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study
Participants: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows:
Inclusion Criteria
Patients aged >= 18 years
COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR)
Exclusion Criteria
Pregnancy or lactation
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive kidney failure
Having a history of participating in a clinical trial during the last 30 days
Intervention and comparator: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days.
Main outcomes: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group.
Randomisation: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com)
Blinding (masking): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study.
Numbers to be randomised (sample size): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required.
Trial Status: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is |
| doi_str_mv | 10.1186/s13063-021-05462-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_webof</sourceid><recordid>TN_cdi_webofscience_primary_000683466700001</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_f8ec5f8fa09e4b76b6d13eb4c80caff8</doaj_id><sourcerecordid>2730340684</sourcerecordid><originalsourceid>FETCH-LOGICAL-c473t-8385d625bbd0b5a061acd26a964942c543d9e6b92036e93e58ca4724d170e2bf3</originalsourceid><addsrcrecordid>eNqNks9qFTEUhwdRbK2-gKuAG0FG828yGReCXLQWCm50HTLJSZs6M-eaZFqu7-Q7mttbinXlKoecLx-Hk1_TvGT0LWNavctMUCVayllLO6l4qx81x6yXXas46x7_VR81z3K-olSKQcinzZGQQkrJ--Pm92kCWEgBS-JS7A8gdvEklkwgBHCF4EImO2KyBdOObG2yMxRI-ZbzMYPNQPJu3hacc3WQS8zbWOxUW77yJcJSbTexXJINXkdP2PCeWJJLWl1Z0x5KWNDhRAKm2knVjHP8VTsOl5JwmmpZUrTT8-ZJsFOGF3fnSfP986dvmy_t-dfTs83H89bJXpRWC915xbtx9HTsLFXMOs-VHZQcJHedFH4ANQ6cCgWDgE47K3suPesp8DGIk-bs4PVor8w2xdmmnUEbze0FpgtjU4luAhM0uC7oYOkAcuzVqDwTMEqnqbMh6Or6cHBt13EG7-o6kp0eSB92lnhpLvDaaMEHSfeC13eChD9XyMXMMTuYJrsArtnwrtN0YJQNFX31D3qFa1rqqgzvBRWSKi0rxQ-US5hzgnA_DKNmnyxzSJapyTK3yTL7Kd4cHt3AiCG7-q0O7h9SWs1CKtXXirJK6_-nNzUuJeKywXUp4g-bf-S3</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2730340684</pqid></control><display><type>article</type><title>Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial</title><source>DOAJ Directory of Open Access Journals</source><source>SpringerNature Journals</source><source>PubMed Central Open Access</source><source>Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><source>PubMed Central</source><source>Springer Nature OA/Free Journals</source><creator>Mahmoodi, Sara ; Yousefi, Mojtaba ; Sadeghi, Omid ; Mahmoodabadi, Ali ; Sadriirani, Mohammadreza ; Hosseinzade, Zahra ; Jahanbakhsh, Abdolhossein ; Panahande, Seyed Bahman ; Saeedinejad, Zaker ; Malekzadeh, Jan Mohamad ; Naghmachi, Mohsen ; Pourmahmoudi, Azizollah</creator><creatorcontrib>Mahmoodi, Sara ; Yousefi, Mojtaba ; Sadeghi, Omid ; Mahmoodabadi, Ali ; Sadriirani, Mohammadreza ; Hosseinzade, Zahra ; Jahanbakhsh, Abdolhossein ; Panahande, Seyed Bahman ; Saeedinejad, Zaker ; Malekzadeh, Jan Mohamad ; Naghmachi, Mohsen ; Pourmahmoudi, Azizollah</creatorcontrib><description>Objectives: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.
Trial design: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study
Participants: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows:
Inclusion Criteria
Patients aged >= 18 years
COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR)
Exclusion Criteria
Pregnancy or lactation
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive kidney failure
Having a history of participating in a clinical trial during the last 30 days
Intervention and comparator: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days.
Main outcomes: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group.
Randomisation: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com)
Blinding (masking): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study.
Numbers to be randomised (sample size): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required.
Trial Status: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021.
Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-021-05462-8</identifier><identifier>PMID: 34344427</identifier><language>eng</language><publisher>LONDON: Springer Nature</publisher><subject>CBC ; Clinical trials ; Coronaviruses ; COVID-19 ; CRP ; ESR ; Infections ; Laboratories ; Letter ; Life Sciences & Biomedicine ; Medicine, Research & Experimental ; protocol ; Randomised controlled trial ; Research & Experimental Medicine ; Science & Technology ; Tea</subject><ispartof>Current controlled trials in cardiovascular medicine, 2021-08, Vol.22 (1), p.514-514, Article 514</ispartof><rights>The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>2</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000683466700001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c473t-8385d625bbd0b5a061acd26a964942c543d9e6b92036e93e58ca4724d170e2bf3</citedby><orcidid>0000-0002-7008-2449</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8329408/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8329408/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2115,27929,27930,39263,53796,53798</link.rule.ids></links><search><creatorcontrib>Mahmoodi, Sara</creatorcontrib><creatorcontrib>Yousefi, Mojtaba</creatorcontrib><creatorcontrib>Sadeghi, Omid</creatorcontrib><creatorcontrib>Mahmoodabadi, Ali</creatorcontrib><creatorcontrib>Sadriirani, Mohammadreza</creatorcontrib><creatorcontrib>Hosseinzade, Zahra</creatorcontrib><creatorcontrib>Jahanbakhsh, Abdolhossein</creatorcontrib><creatorcontrib>Panahande, Seyed Bahman</creatorcontrib><creatorcontrib>Saeedinejad, Zaker</creatorcontrib><creatorcontrib>Malekzadeh, Jan Mohamad</creatorcontrib><creatorcontrib>Naghmachi, Mohsen</creatorcontrib><creatorcontrib>Pourmahmoudi, Azizollah</creatorcontrib><title>Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>TRIALS</addtitle><description>Objectives: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.
Trial design: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study
Participants: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows:
Inclusion Criteria
Patients aged >= 18 years
COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR)
Exclusion Criteria
Pregnancy or lactation
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive kidney failure
Having a history of participating in a clinical trial during the last 30 days
Intervention and comparator: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days.
Main outcomes: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group.
Randomisation: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com)
Blinding (masking): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study.
Numbers to be randomised (sample size): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required.
Trial Status: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021.
Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.</description><subject>CBC</subject><subject>Clinical trials</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>CRP</subject><subject>ESR</subject><subject>Infections</subject><subject>Laboratories</subject><subject>Letter</subject><subject>Life Sciences & Biomedicine</subject><subject>Medicine, Research & Experimental</subject><subject>protocol</subject><subject>Randomised controlled trial</subject><subject>Research & Experimental Medicine</subject><subject>Science & Technology</subject><subject>Tea</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqNks9qFTEUhwdRbK2-gKuAG0FG828yGReCXLQWCm50HTLJSZs6M-eaZFqu7-Q7mttbinXlKoecLx-Hk1_TvGT0LWNavctMUCVayllLO6l4qx81x6yXXas46x7_VR81z3K-olSKQcinzZGQQkrJ--Pm92kCWEgBS-JS7A8gdvEklkwgBHCF4EImO2KyBdOObG2yMxRI-ZbzMYPNQPJu3hacc3WQS8zbWOxUW77yJcJSbTexXJINXkdP2PCeWJJLWl1Z0x5KWNDhRAKm2knVjHP8VTsOl5JwmmpZUrTT8-ZJsFOGF3fnSfP986dvmy_t-dfTs83H89bJXpRWC915xbtx9HTsLFXMOs-VHZQcJHedFH4ANQ6cCgWDgE47K3suPesp8DGIk-bs4PVor8w2xdmmnUEbze0FpgtjU4luAhM0uC7oYOkAcuzVqDwTMEqnqbMh6Or6cHBt13EG7-o6kp0eSB92lnhpLvDaaMEHSfeC13eChD9XyMXMMTuYJrsArtnwrtN0YJQNFX31D3qFa1rqqgzvBRWSKi0rxQ-US5hzgnA_DKNmnyxzSJapyTK3yTL7Kd4cHt3AiCG7-q0O7h9SWs1CKtXXirJK6_-nNzUuJeKywXUp4g-bf-S3</recordid><startdate>20210803</startdate><enddate>20210803</enddate><creator>Mahmoodi, Sara</creator><creator>Yousefi, Mojtaba</creator><creator>Sadeghi, Omid</creator><creator>Mahmoodabadi, Ali</creator><creator>Sadriirani, Mohammadreza</creator><creator>Hosseinzade, Zahra</creator><creator>Jahanbakhsh, Abdolhossein</creator><creator>Panahande, Seyed Bahman</creator><creator>Saeedinejad, Zaker</creator><creator>Malekzadeh, Jan Mohamad</creator><creator>Naghmachi, Mohsen</creator><creator>Pourmahmoudi, Azizollah</creator><general>Springer Nature</general><general>BioMed Central</general><general>BMC</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-7008-2449</orcidid></search><sort><creationdate>20210803</creationdate><title>Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial</title><author>Mahmoodi, Sara ; Yousefi, Mojtaba ; Sadeghi, Omid ; Mahmoodabadi, Ali ; Sadriirani, Mohammadreza ; Hosseinzade, Zahra ; Jahanbakhsh, Abdolhossein ; Panahande, Seyed Bahman ; Saeedinejad, Zaker ; Malekzadeh, Jan Mohamad ; Naghmachi, Mohsen ; Pourmahmoudi, Azizollah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-8385d625bbd0b5a061acd26a964942c543d9e6b92036e93e58ca4724d170e2bf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>CBC</topic><topic>Clinical trials</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>CRP</topic><topic>ESR</topic><topic>Infections</topic><topic>Laboratories</topic><topic>Letter</topic><topic>Life Sciences & Biomedicine</topic><topic>Medicine, Research & Experimental</topic><topic>protocol</topic><topic>Randomised controlled trial</topic><topic>Research & Experimental Medicine</topic><topic>Science & Technology</topic><topic>Tea</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mahmoodi, Sara</creatorcontrib><creatorcontrib>Yousefi, Mojtaba</creatorcontrib><creatorcontrib>Sadeghi, Omid</creatorcontrib><creatorcontrib>Mahmoodabadi, Ali</creatorcontrib><creatorcontrib>Sadriirani, Mohammadreza</creatorcontrib><creatorcontrib>Hosseinzade, Zahra</creatorcontrib><creatorcontrib>Jahanbakhsh, Abdolhossein</creatorcontrib><creatorcontrib>Panahande, Seyed Bahman</creatorcontrib><creatorcontrib>Saeedinejad, Zaker</creatorcontrib><creatorcontrib>Malekzadeh, Jan Mohamad</creatorcontrib><creatorcontrib>Naghmachi, Mohsen</creatorcontrib><creatorcontrib>Pourmahmoudi, Azizollah</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mahmoodi, Sara</au><au>Yousefi, Mojtaba</au><au>Sadeghi, Omid</au><au>Mahmoodabadi, Ali</au><au>Sadriirani, Mohammadreza</au><au>Hosseinzade, Zahra</au><au>Jahanbakhsh, Abdolhossein</au><au>Panahande, Seyed Bahman</au><au>Saeedinejad, Zaker</au><au>Malekzadeh, Jan Mohamad</au><au>Naghmachi, Mohsen</au><au>Pourmahmoudi, Azizollah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><stitle>TRIALS</stitle><date>2021-08-03</date><risdate>2021</risdate><volume>22</volume><issue>1</issue><spage>514</spage><epage>514</epage><pages>514-514</pages><artnum>514</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Objectives: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.
Trial design: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study
Participants: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows:
Inclusion Criteria
Patients aged >= 18 years
COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR)
Exclusion Criteria
Pregnancy or lactation
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive kidney failure
Having a history of participating in a clinical trial during the last 30 days
Intervention and comparator: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days.
Main outcomes: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group.
Randomisation: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com)
Blinding (masking): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study.
Numbers to be randomised (sample size): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required.
Trial Status: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021.
Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.</abstract><cop>LONDON</cop><pub>Springer Nature</pub><pmid>34344427</pmid><doi>10.1186/s13063-021-05462-8</doi><tpages>2</tpages><orcidid>https://orcid.org/0000-0002-7008-2449</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1745-6215 |
| ispartof | Current controlled trials in cardiovascular medicine, 2021-08, Vol.22 (1), p.514-514, Article 514 |
| issn | 1745-6215 1745-6215 |
| language | eng |
| recordid | cdi_webofscience_primary_000683466700001 |
| source | DOAJ Directory of Open Access Journals; SpringerNature Journals; PubMed Central Open Access; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; PubMed Central; Springer Nature OA/Free Journals |
| subjects | CBC Clinical trials Coronaviruses COVID-19 CRP ESR Infections Laboratories Letter Life Sciences & Biomedicine Medicine, Research & Experimental protocol Randomised controlled trial Research & Experimental Medicine Science & Technology Tea |
| title | Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-12T00%3A36%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_webof&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Green%20tea%20intake%20and%20its%20effect%20on%20laboratory%20parameters%20and%20disease%20symptoms%20in%20hospitalised%20patients%20with%20Covid%2019:%20a%20structured%20protocol%20for%20a%20randomized%20controlled%20trial&rft.jtitle=Current%20controlled%20trials%20in%20cardiovascular%20medicine&rft.au=Mahmoodi,%20Sara&rft.date=2021-08-03&rft.volume=22&rft.issue=1&rft.spage=514&rft.epage=514&rft.pages=514-514&rft.artnum=514&rft.issn=1745-6215&rft.eissn=1745-6215&rft_id=info:doi/10.1186/s13063-021-05462-8&rft_dat=%3Cproquest_webof%3E2730340684%3C/proquest_webof%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2730340684&rft_id=info:pmid/34344427&rft_doaj_id=oai_doaj_org_article_f8ec5f8fa09e4b76b6d13eb4c80caff8&rfr_iscdi=true |