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The effect of compound "Ma-ol-asal" on clinical manifestations and quality of life of chronic obstructive pulmonary disease (COPD) patients

Protocol summary

Study aim
In this study, the effectiveness of compound "Ma-ol-asal" syrup is measured on the improvement of clinical signs and quality of life of chronic obstructive pulmonary disease (COPD).
Design
Randomized, double blind, with control group, Clinical trials
Settings and conduct
Patients who refer to in pulmonary clinic ,at first, an examination and spiromety is done for them.Then, they complete CAT and St. Georges respiratory questionnaires. With randomization (blocks), Patients will be divided into 2 groups of 38 people: Intervention Group (Ma-ol-asal", Oral Syrup, 10 ml third a day) and Control Group (placebo, Oral Syrup, 10 ml third a day). Patients will be treated for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: participate to study, not allergic to any of the components of the drug; Exclusion criteria: very severe disease and/or severe and requiring hospitalization, underlying conditions (CF, bronchopulmonary, dysplasia, heart failure, bronchiectasis, pulmonary embolism and sarcoidosis) and Taking drugs such as aspirin, beta-blocker, and NSAID.
Intervention groups
Experimental group, receive the standard treatment and "Ma-ol-asal"syrup.Control group, patients receive standard treatment and placebo.
Main outcome variables
Clinical manifestation, Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190217042737N2
Registration date: 2020-04-04, 1399/01/16
Registration timing: retrospective

Last update: 2020-04-04, 1399/01/16
Update count: 0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Zohreh Poursaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 7434
Email address
zpoursaleh7@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2020-01-21, 1398/11/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The effect of compound "Ma-ol-asal" on clinical manifestations and quality of life of chronic obstructive pulmonary disease (COPD) patients
Public title
The effect of compound "Ma-ol-asal" of chronic obstructive pulmonary disease (COPD) patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COPD referring to the lung clinic People who are willing to participate in the study.
Exclusion criteria:
Very severe COPD require hospitalization Underlying illnesses, such as CF, Broncho-pulmonary dysplasia, heart failure, broncho-tracheomalacia, bronchiectasis, pulmonary embolism and sarcoidosis. Taking drugs such as aspirin, beta-blocker and NSAID. Allergic to any of the components of "Ma-ol-asal"
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 76
Actual sample size reached: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Based on four randomized chains and blocks of four, Patients will be divided into 2 groups of 38 people: Intervention Group and Control Group. Patients will be treated for 8 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, major researcher, lung specialist, respiratory testing technician, use of placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiatallah University of Medical Sciences
Street address
Nasri St.,South Sheikh Baha'i avenue.,Mulla- Sadra Avenue.,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.BMSU.REC.1396.399

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease (COPD)
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Clinical symptoms
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after commencing consumption of the compound syrup
Method of measurement
CAT questionnaire

2

Description
Quality of life
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after commencing consumption of the compound syrup
Method of measurement
The St George's respiratory questionnaire

Secondary outcomes

1

Description
Respiratory test changes in FEV1, FEV1 / FVC
Timepoint
At the beginning of the study (before the intervention) and 8 weeks after commencement of the administration of the compound syrup
Method of measurement
Pulmonary functional test

Intervention groups

1

Description
Intervention group: Oral syrup,compound "Ma-ol-asal Syrup contains honey, ginger, cinnamon, cardamom, saffron, Alpinia officinarum, oral syrup (250ml),10 ml three times a day,for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Oral syrup, a mixture of honey, water, color additive, etc. Oral Syrup (250ml), 10 ml three times a day, for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Polyclinic Bahaqiallah
Full name of responsible person
Zohreh Poursaleh
Street address
Mulla-Sadra St; Vanak Squa
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8216 2314
Email
z_poursaleh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology University
Street address
Mulla-Sadra St, Vanak Squa.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
z_poursaleh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Poursaleh
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mulla- Sadra St, Vanak Squa.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2503
Email
z_poursaleh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Ghanei/ Rasul Choopani
Position
Professor/Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pulmonologist/ Traditional medicine
Street address
Shahid Beheshti Faculty of Medicine-No. 8.,Shams Alley.,Tavanir Cross., Vali Asr St., Vanak Square.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 912 379 0148
Fax
Email
rchoopani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Poursaleh
Position
Candidate of PhD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Beheshti Faculty of Medicine-No. 8.,Shams Alley.,Tavanir Cross., Vali Asr St., Vanak Square.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 7787 7434
Fax
Email
zpoursaleh7@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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