Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure : A double blind, randomized controlled trial
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Protocol summary
Inclusion criteria: age 40 to 75, systolic heart failure with ejection fraction equal or lesser than 40 percent, continuing heart medications, prescribed by cardiologist, Heart failure stable according to the diagnosis and under the supervision of a heart specialist
Heart failure with NYHA Class II-III
Exclusion criteria: Pregnancy, Breast feeding, malignancy, Allergy to Aloe Vera gel, chronic inflammatory disease, severe liver disease, Acute infectious disease, Decompensation heart, History of peptic ulcer or hemorrhoids
Inclusion criteria:Written informed consent, age:18 years or above, systolic heart failure with ejection fraction equal or lesser than 40 percent or Heart failure with NYHA Class II-III, continuing heart medications, prescribed by cardiologist, Heart failure stable according to the diagnosis and under the supervision of a heart specialist
Exclusion criteria: Pregnancy, Breast feeding, malignancy, Allergy to Aloe Vera gel, chronic inflammatory disease, severe liver disease, Acute infectious disease, Decompensation heart, History of peptic ulcer or hemorrhoids
Inclusion criteria:Written informed consent, age 40 to 75:18 years or above, systolic heart failure with ejection fraction equal or lesser than 40 percent or Heart failure with NYHA Class II-III, continuing heart medications, prescribed by cardiologist, Heart failure stable according to the diagnosis and under the supervision of a heart specialist Heart failure with NYHA Class II-III Exclusion criteria: Pregnancy, Breast feeding, malignancy, Allergy to Aloe Vera gel, chronic inflammatory disease, severe liver disease, Acute infectious disease, Decompensation heart, History of peptic ulcer or hemorrhoids
معیار ورود:سن 40تا75سال، ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از 40 درصد، ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست، ابتلا به نارسایی قلبی stable طبق تشخیص و زیر نظر فوق تخصص نارسایی قلب
نارسایی قلب با NYHA Class II-III
معیار عدم ورود:حاملگی، شیردهی، ابتلا به کانسر، حساسیت به آلوئه ورا، بیماری التهابی مزمن، نارسایی مزمن کلیوی، بیماری کلاژن واسکولار، بیماری مزمن کبدی، بیماری عفونی حاد، عدم جبران نارسایی قلبی، سابقه بیماری پپتیک اولسر، همورویید
معیار ورود:رضایتنامه کتبی آگاهانه، سن بالای 18 سال، ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از 40 درصد یا نارسایی قلب با NYHA Class II-III ، ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست، ابتلا به نارسایی قلبی stable طبق تشخیص و زیر نظر فوق تخصص نارسایی قلب
معیار عدم ورود:حاملگی، شیردهی، ابتلا به کانسر، حساسیت به آلوئه ورا، بیماری التهابی مزمن، نارسایی مزمن کلیوی، بیماری کلاژن واسکولار، بیماری مزمن کبدی، بیماری عفونی حاد، عدم جبران نارسایی قلبی، سابقه بیماری پپتیک اولسر، همورویید
معیار ورود:رضایتنامه کتبی آگاهانه، سن 40تا75سالبالای 18 سال، ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از 40 درصد یا نارسایی قلب با NYHA Class II-III ، ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست، ابتلا به نارسایی قلبی stable طبق تشخیص و زیر نظر فوق تخصص نارسایی قلب نارسایی قلب با NYHA Class II-III معیار عدم ورود:حاملگی، شیردهی، ابتلا به کانسر، حساسیت به آلوئه ورا، بیماری التهابی مزمن، نارسایی مزمن کلیوی، بیماری کلاژن واسکولار، بیماری مزمن کبدی، بیماری عفونی حاد، عدم جبران نارسایی قلبی، سابقه بیماری پپتیک اولسر، همورویید
General information
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75
Year
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Yes
1
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There were two modifications to the inclusion criteria:
Age: 18 years or above
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
There were two modifications to the inclusion criteria: Age: 18 years or above Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
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در مورد معیار های ورود دو مورد اصلاح شد:
1-سن بالای 18 سال
2- ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای(EF) کمتر از ۴۰ درصد یا نارسایی قلب با NYHA Class II-III (در پیشنویس قبلی طرح، این دو مورد EF و کلاسNYHA جداگانه وارد شده بود در حالیکه یکی از این دو مورد نیز اگر مثبت باشد برای ورود به طرح کافی است)
علت تصحیح این دو مورد ذکرشده در بالا: طبق مقالات مشابه (تاثیر گیاهان دارویی بر نارسایی قلب، معیار ورودسن بالای18 سال بیان شده.
رفرنس:
Zick SM, Vautaw BM, Gillespie B, Aaronson KDJEjohf. Hawthorn extract randomized blinded chronic heart failure (HERB CHF) trial. 2009;11(10):990-9.
در مورد معیار های ورود دو مورد اصلاح شد: 1-سن بالای 18 سال 2- ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای(EF) کمتر از ۴۰ درصد یا نارسایی قلب با NYHA Class II-III (در پیشنویس قبلی طرح، این دو مورد EF و کلاسNYHA جداگانه وارد شده بود در حالیکه یکی از این دو مورد نیز اگر مثبت باشد برای ورود به طرح کافی است) علت تصحیح این دو مورد ذکرشده در بالا: طبق مقالات مشابه (تاثیر گیاهان دارویی بر نارسایی قلب، معیار ورودسن بالای18 سال بیان شده. رفرنس: Zick SM, Vautaw BM, Gillespie B, Aaronson KDJEjohf. Hawthorn extract randomized blinded chronic heart failure (HERB CHF) trial. 2009;11(10):990-9.
Adults aged 15 to 45 years
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40%
Patients willing to continue their standard continuing heart medications which prescribed by cardiologist
Ambulatory systolic heart failure patients in stable condition (no hospitalization during the trial and no planned surgery)
Functional New York Heart Association NYHA Class II-III
Written informed consent
Age: 18 years or above
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
Patients willing to continue their standard continuing heart medications which prescribed by cardiologist
Ambulatory systolic heart failure patients in stable condition (no hospitalization during the trial and no planned surgery)
Adults aged 15 to 45Written informed consent Age: 18 years or above Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III. Patients willing to continue their standard continuing heart medications which prescribed by cardiologist Ambulatory systolic heart failure patients in stable condition (no hospitalization during the trial and no planned surgery) Functional New York Heart Association NYHA Class II-III
سن ۴۰ تا ۷۵ سال
ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از ۴۰ درصد
ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست
ابتلا به نارسایی قلبی سیستولیک و stable(نداشتن برنامه بستری یا جراحی در طول کارآزمایی)
نارسایی قلب با NYHA Class II-III
رضایت آگاهانه کتبی
سن بالای 18 سال
ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از ۴۰ درصد یا نارسایی قلب با NYHA Class II-III
ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست
ابتلا به نارسایی قلبی سیستولیک و stable(نداشتن برنامه بستری یا جراحی در طول کارآزمایی)
رضایت آگاهانه کتبی سن ۴۰ تا ۷۵بالای 18 سال ابتلا به نارسایی قلبی سیستولیک با کسر تخلیه ای کمتر از ۴۰ درصد یا نارسایی قلب با NYHA Class II-III ادامه داروهای قلبی تجویز شده توسط کاردیولوژیست ابتلا به نارسایی قلبی سیستولیک و stable(نداشتن برنامه بستری یا جراحی در طول کارآزمایی) نارسایی قلب با NYHA Class II-III
Recruitment centers
#1
Name of recruitment center - English: Cardiovascular Afshar Specialty Clinic affiliated to Yazd Shahid Sadoughi University of Medical Scie
Name of recruitment center - Persian: کلینیک فوق تخصصی قلب و عروق افشار وابسته به دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Saeideh Sabbaghzadegan
Full name of responsible person - Persian: سعیده صباغ زادگان
Street address - English: Heart Clinic of Afshar Hospital, Jomhoory street, Yazd, Iran
Street address - Persian: ايران، يزد، بلوار جمهوري اسلامي، بيمارستان افشار
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8917156735
Phone: +98 35 1525 6012
Fax:
Email: sabbaghzadegan.s@tak.iums.ac.ir
Web page address:
Name of recruitment center - English: Cardiology clinic, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Name of recruitment center - Persian: کلینیک فوق تخصصی قلب و عروق دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person - English: Saeideh Sabbaghzadegan
Full name of responsible person - Persian: سعیده صباغ زادگان
Street address - English: Heart clinic, jomhoory street, Yazd, Iran
Street address - Persian: ايران، يزد، بلوار جمهوري اسلامي، کلینیک قلب
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8917156735
Phone: +98 35 1525 6012
Fax:
Email: sabbaghzadegan.s@tak.iums.ac.ir
Web page address:
Name of recruitment center - English: Cardiovascular Afshar Specialty Clinic affiliated to YazdCardiology clinic, Shahid Sadoughi University of Medical ScieSciences, Yazd, Iran Name of recruitment center - Persian: کلینیک فوق تخصصی قلب و عروق افشار وابسته به دانشگاه علوم پزشکی شهید صدوقی یزد Full name of responsible person - English: Saeideh Sabbaghzadegan Full name of responsible person - Persian: سعیده صباغ زادگان Street address - English: Heart Clinic of Afshar Hospitalclinic, Jomhooryjomhoory street, Yazd, Iran Street address - Persian: ايران، يزد، بلوار جمهوري اسلامي، بيمارستان افشارکلینیک قلب City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8917156735 Phone: +98 35 1525 6012 Fax: Email: sabbaghzadegan.s@tak.iums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Naserbakht
Full name of responsible person - Persian: دكتر مرتضی ناصر بخت
Street address - English: Hemat High way Iran University of Medical Siences, Tehran, Iran
Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Naserbakht
Full name of responsible person - Persian: دكتر مرتضی ناصر بخت
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran
Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Morteza Naserbakht Full name of responsible person - Persian: دكتر مرتضی ناصر بخت Street address - English: Hemat High way Iran University of Medical SiencesSciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 86701 Fax: Email: adminsite@iums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure
Design
A concealed, randomized, parallel group trial with blinded outcome assessment of 26 patients.
Settings and conduct
Aloe Vera gel or placebo is given one capsule in the same condition every 12 hours for 8 weeks to the systolic heart failure patients referred to the Cardiovascular Clinic of Yazd University of Medical Science
The participants will be allocate into two groups of intervention (Aloe Vera) and control (placebo) with titles A and B by using block randomization method.
participants, researcher, person who gives drug and investigators will be blinded to all study
Only the randomization statistician will be unblinded to the treatment assignment
Participants/Inclusion and exclusion criteria
Inclusion criteria:Written informed consent, age:18 years or above, systolic heart failure with ejection fraction equal or lesser than 40 percent or Heart failure with NYHA Class II-III, continuing heart medications, prescribed by cardiologist, Heart failure stable according to the diagnosis and under the supervision of a heart specialist
Exclusion criteria: Pregnancy, Breast feeding, malignancy, Allergy to Aloe Vera gel, chronic inflammatory disease, severe liver disease, Acute infectious disease, Decompensation heart, History of peptic ulcer or hemorrhoids
Intervention groups
Participants will given interventions two times a day for next 8 weeks.Each capsule contains 150 mg of Aloe Vera gel or 150 mg starch in the same shape, color and cans.
Main outcome variables
Minnesota Living with Heart Failure Questionnaire Score (MLHFQ)
The distance covered during a six-minute walk test (6 MWT)
General information
Reason for update
There were two modifications to the inclusion criteria:
Age: 18 years or above
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
Acronym
IRCT registration information
IRCT registration number:IRCT20190803044426N1
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2020-02-23, 1398/12/04
Update count:2
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Saeideh Sabbaghzadegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0388
Email address
sabbaghzadegan.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of “Aloe Vera” oral gel on the quality of life in patients with systolic heart failure : A double blind, randomized controlled trial
Public title
Efficacy of Aloe Vera gel in systolic heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent
Age: 18 years or above
Systolic heart failure disease with reduced left ventricular ejection fraction ≤40% or Symptomatic chronic heart failure NYHA class II-III.
Patients willing to continue their standard continuing heart medications which prescribed by cardiologist
Ambulatory systolic heart failure patients in stable condition (no hospitalization during the trial and no planned surgery)
Exclusion criteria:
Pregnancy
Breast feeding
Hypersensitivity to Aloe Vera
Chronic Inflammatory disease
Collagen vascular disease
History of peptic ulcer
Acute infectious disease
Decompensated heart failure
Chronic liver disease
Chronic renal failure
Hemorrhoids
Malignancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used
Blocking is used to balance the number of samples assigned to each study group, because we have two intervention groups, use equal 4 blocks and create all 4 possible modes and then with Excel software we randomly select a number of blocks.
Since the sample size in this study is 26 cases (13 cases in each group), by using Excel software, 7 blocks of 4 are randomly used.
The label of interventions to one of the letters A or B and the sequence of randomization determined by the statistical consultant.
For allocation concealment,drug delivery and the sequence of randomization is not available to researchers and evaluators while is the responsibility of the off-site individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
After evaluation by the researcher, participants are referred to the off-site individual(drug Delivery Person) and receive A or B intervention according to a random sequence list
The drug and placebo are coded in similar capsules and in identical packages, with the same color and participants, researchers, drug Delivery Person and investigators are not aware of treatment allocation. Only the statistician will be unblinded to the treatment assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.IUMS.REC.1398.457
Health conditions studied
1
Description of health condition studied
Systolic heart failure
ICD-10 code
I50.22
ICD-10 code description
Chronic systolic (congestive) heart failure
Primary outcomes
1
Description
Quality of Life Score in the Minnesota Questionnaire
Timepoint
Measure the quality of life score at the beginning of study(before intervention)and one week after taking Aloe Vera gel
Method of measurement
Minnesota Living With Heart Failure Questionnaire
Secondary outcomes
1
Description
The distance traveled in six minute walk test
Timepoint
Measure the distance traveled in six minute walk test at the beginning of study(before intervention)and one week after taking the Aloe Vera gel
Method of measurement
Six minute walk test
Intervention groups
1
Description
Patients will receive Aloe Vera gel capsule two times a day for next 8 weeks.Each capsule contains 150 mg of Aloe Vera gel . The drug will be provided by Shahid Beheshti university pharmacy lab
Category
Treatment - Drugs
2
Description
Placebo capsule that is identically appearing with Aloe Vera capsule will be administered to patients in placebo group. patients will receive placebo drug two times a day for next 8 weeks. Capsules contain 150 mg starch which will be provided in the Shahid Beheshti university pharmacy lab
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology clinic, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Saeideh Sabbaghzadegan
Street address
Heart clinic, jomhoory street, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917156735
Phone
+98 35 1525 6012
Email
sabbaghzadegan.s@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeideh Sabbaghzadegan
Position
MD, Ph.D student of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.847, Beginning of Behesht St, South side of Park City, Vahdat-e Islamic St, Hassan Abad Sq
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Fax
Email
sabbaghzadegan.s@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Majid Dadmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.847, Beginning of behesht Street, South Park City, Vahdat Islamic Street, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
dadmehr.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeideh Sabbaghzadegan
Position
MD, Ph.D student of Iranian Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 847 , Vahdat-e-Islami St , South side of Park City , Hassan Abad Square, Behesht Street, Faculty of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Fax
Email
ssbbaghzadegan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available