History
# Registration date Revision Id
2 2020-06-24, 1399/04/04 141066
1 2019-01-27, 1397/11/07 77003
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
primary aims : determiniation effect of effect of Chammomile & Lemon balm syrupe on chest pain and quality of life in patient with cardiac syndrome x secondary aims: 1. design and manufacture of standard chammomile&Lemon balm syrupe 2. Comparision of changes in chest pain in patient with cardiac syndrome x in interventional group with control group 3.Comparision of changes in quality of life in patient with cardiac syndrome x in interventional group with control group objective aims: provide a potentially effective treatment forcardiac syndrome x
Design
The study is a double-blind clinical trial with two parallel control and intervention groups that has been randomized with Block Randomization. Sample size with 20% probability of dropping samples is two groups of 20 people. The phase of study is phase 3
Settings and conduct
Conducted study: Tehran heart center How to do a study: A double-blind clinical trial is a randomized blocking study. The target community: patient with cardiac syndrome x study groups: two groups of control and intervention. To the control group, placebo and to the intervention group, the chamomile product - lemon balm (5 cc twice daily) is given.
Participants/Inclusion and exclusion criteria
inclusion criteria: Angina- like chest pain positive exercise stress test angiographically normal epicardial coronary arteries no response to treatments in conventional medicine exclusion criteria: sever Valvular heart disease cardiomyopathy coronary spasm LV dysfunction uncontrolled Diabetes mellitus uncontrolled HTN History of myocardial infarction
Intervention groups
interventional group: chammomile-lemonbalm syroup control group: placebod
Main outcome variables
The overall score of pain in the Seattle angina Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180608040014N1
Registration date: 2019-01-27, 1397/11/07
Registration timing: prospective

Last update: 2019-01-27, 1397/11/07
Update count: 1
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Samane Noroozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 1359
Email address
snoroozi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study on the effect of Chammomile(Matricaria chamomilla L.)&Lemon balm (Melissa officinalis L.) syrupe on chest pain and quality of life in patient with cardiac syndrome x
Public title
The study on the effect of chammomile&lemon balm syrupe in cardiac syndrome x
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Angina- like chest pain positive exercise stress test angiographically normal epicardial coronary arteries no response to treatments in conventional medicine
Exclusion criteria:
sever Valvular heart disease cardiomyopathy coronary spasm LV dysfunction uncontrolled Diabetes mellitus uncontrolled HTN History of myocardial infarction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using dual and triple blocks, the randomization sequence is prepared. First, all double blocks such as AABB and triple blocks like AABBAB were developed. Then they were given a score and randomly selected sequences from each of them and sorted in the following order. ABABBABBAABABABBABAABAABBABBAAABABABBABAABBBAABABABABBABAAABABABAB This arrangement will be in 60 envelopes in the same way, and the person responsible for the rendezvous will open the relevant envelope for each person in the study and identify the treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients blinding are treated with placebo, which is similar to the original drug. People who measure heart rate and quality of life in patients are not informed about the patient's treatment group. In the event of any uncommon side effects in patients regardless of treatment group, the patient will be excluded from the study and thus there will be no disturbances in blindness. Medication and placebo will be prepared and coded by the traditional consultant of the pharmaceutical consultant, with maximum apparent similarity in terms of packaging and content (flavor and aroma). This coding for the drug and the placebo is confidential by the pharmaceutical specialist, and the continuous numbers and rows are determined by the four blocks of them and will be delivered without disclosure to the researcher. The researcher and the patient are completely unaware of the content and the researcher will provide patients with a randomized randomized blocking drug and placebo. At the end of the study, the rows of drugs and placebo are aggregated by a pharmaceutical expert and will be provided to the expert statistical analyst by unlocking the codes in two groups A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
vice-chancellor in research affairs,sixth floor, the Central Organization of Tehran University of Medical Sciences,st.ghods, Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-11-23, 1397/09/02
Ethics committee reference number
IR.TUMS.VCR.REC.1397.618

Health conditions studied

1

Description of health condition studied
cardiac syndrome x
ICD-10 code
I20.9
ICD-10 code description
Angina pectoris, unspecified

Primary outcomes

1

Description
The overall score of pain in the Seattle Angina Questionnaire
Timepoint
at first and end of study(month(1),month(3)
Method of measurement
the Seattle Angina questionnare

Secondary outcomes

1

Description
Quality of Life Score in SF36 Quality of Life Questionnaire
Timepoint
at first and end of study(month(1),month(3))
Method of measurement
SF36 Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: chammomile&lemon balm syrupe control group: placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
tehran heart center
Full name of responsible person
دکتر علی واشقانی فراهانی
Street address
Tehran Heart Center-- Jalal Al Ahmad Highway-north kargar Ave-tehran
City
tehran
Province
Tehran
Postal code
19378-36814
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
دکتر محمد علی صحرائیان
Street address
vice-chancellor in research affairs,sixth floor, the Central Organization of Tehran University of Medical Sciences,st.ghods, Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samane noroozi
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ahmadie Health Center,No. 27,st north sarparst, West of Taleghani Street,Phelestine Square
City
Tehran
Province
Tehran
Postal code
0229888567
Phone
+98 218897652730
Email
dr.samanenoroozi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hossein rezaiezade
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ahmadie Health Center,No. 27,st north sarparst, West of Taleghani Street,Phelestine Square
City
Tehran
Province
Tehran
Postal code
STPM.tums.ac.ir
Phone
+98 21 8899 0837
Email
hosseinrezaeizade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
samane noroozi
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ahmadie Health Center,No. 27,st north sarparst, West of Taleghani Street,Phelestine Square
City
tehran
Province
Tehran
Postal code
STPM.tums.ac.ir
Phone
+98 218897652730
Email
dr.samanenoroozi@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after being unrecognizable in Excel.
When the data will become available and for how long
Up to 5 years after printing results
To whom data/document is available
Researchers at the academic and scientific institutes of people who are in the field of drug production can apply for them.
Under which criteria data/document could be used
1- Performing the same task on heart disease 2- Animal studies 3. drug production
From where data/document is obtainable
Scientific Researcher: Dr. Hossein Rezaezadeh, emai:hosseinrezaeizade@gmail.com tel:09127038842
What processes are involved for a request to access data/document
1-At the request of a magazine after the acceptance of the article for arbitration 2. If a researcher or a drug manufacturer wants to do the same, they can use the data if they refer to this study.
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