Evaluating the effect of topical combination galbanum oil and dry cupping therapy to alleviate COVID-19 patients symptoms
Design
Clinical trial with control group with parallel groups, without blinding, randomized, phase 3 on 60 patients. Block randomization is used for randomization.
Settings and conduct
Available standard treatment (according to the latest protocol of the Covid-19 headquarters) + Initially, 2 cc of galbanum oil is massaged in the back of the chest until the oil is absorbed into the skin + hot cupping behind the chest at a distance of 4 cm from the vertebral spines, fixed at point T4 for one minute and sliding on both sides of the spine to It is performed for 5 minutes, three times a day, at the time of hospitalization for 3- 5 days (from the first day of hospitalization to a maximum of 5 days of hospitalization). Hot cupping using a medium-sized balloon cup (cup opening width is 5 cm and cup height is 8 cm with a suction of about 10-15 mm).
Place of study of Imam Khomeini Hospital Complex in Tehran
Participants/Inclusion and exclusion criteria
Patients aged 18-80 years with positive PCR test COVID-19 With inpatient clinical criteria (T>38°C or severe cough or shortness of breath or RR> 24 per min or O2 sat <93%) non-entry: pregnancy Breastfeeding,coagulopathy disease, vertebral fracture or herniated disc Hearth and renal failure
Intervention groups
The case group includes people who, in addition to standard treatment for coronavirus infectious disease, receive dry cupping and galbanum oil.
The control group includes people who receive only standard treatment for coronavirus infectious disease.
Main outcome variables
The primary outcome involves a recovery period in which the patient is in a position to: fever <37.2 ° in the early morning or <37.8 during the day - number of breaths ≤ 24 in room air - O2sat> 94 in room air and lack of cough or mild cough.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201111049349N1
Registration date:2021-11-10, 1400/08/19
Registration timing:prospective
Last update:2021-11-10, 1400/08/19
Update count:0
Registration date
2021-11-10, 1400/08/19
Registrant information
Name
Fatemeh Emadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 4055
Email address
fatemeh12emadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of topical combination galbanum oil and dry cupping therapy to alleviate COVID-19 patients symptoms
Public title
Effect of dry cupping therapy and galbanum oil in treatment of coronavirus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test
From 18 to 80 years old (male and female)
Clinical criteria for hospitalization (fever ≥ 38 °C- sever cough or shortness of breath or blood oxygen saturation≤ 93% or respiratory Rate ≥24 breaths/minute or positive CPR
Completion of the informed consent form by the patient or his/her companions
Exclusion criteria:
Pregnancy or breastfeeding
intubation
Existence of any history of allergies and skin allergies to the consumption of any of the components of the herbal product
Hearth failure
renal failure
Receive chemotherapy
vertebral fracture or herniated disc
Open wound at the site of cupping
Inability and unwillingness of the patient to fill out a personal consent form to enter the study
Coagulation disease
Immune Deficiency Disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving cupping and control group (Assignment). Then based on blocks and allocation sequences cupping therapy will be given to patients. This is an open-label study and blinding will not happen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Tehran-Qom Highway, Opposite side of Imam Khomeini Holy Shrine, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.SHAHED.REC.1399.108
Health conditions studied
1
Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Percentage of blood oxygen saturation
Timepoint
Before the intervention and days 1,2,3,4,5 after the intervention
Method of measurement
Pulse oximeter device
Secondary outcomes
1
Description
Sevierty of cough
Timepoint
Before the intervention and days 1,2,3,4,5 after the intervention
Method of measurement
CTCAE version 5 (Common Terminology Criteriafor Adverse Events Version 5.0)
2
Description
Severe need for oxygen therapy
Timepoint
Before the intervention and days 1,2,3,4,5 after the intervention
Method of measurement
CTCAE version 5
3
Description
Sevierty of dyspnea
Timepoint
Before the intervention and days 1,2,3,4,5 after the intervention
Method of measurement
CTCAE version 5
4
Description
Sevierty of Chest pain (non-cardiac)
Timepoint
Before the intervention and days 1,2,3,4,5 after the intervention
Method of measurement
CTCAE version 5
Intervention groups
1
Description
Intervention group: The group which receive cupping therapy with galbanum oil application and standard medicines. Preparation of medicine:To prepare galbanum essential oil, galbanum gum is prepared from a suitable type of reputable herbal market and then, after the approval of a botanist, the voucher number is received from the herbarium of Faculty of Pharmacy, University of Tehran. Then, to prepare its essential oil, 200 g galbanum is poured into a balloon. Then, using water distillation method (hydrodistillation) and Clevenger apparatus, essential oil is extracted for 4 hours and the oil percentage is calculated (V/W). The water residue is removed by anhydrous sodium sulfate and the achieved oil is stored in a dark container in a refrigerator at 4-5°C prior to use in formulation or in hexane or petroleum ether solvent for essential oil components analysis by GC /MS.The achieved galbanum essential oil was then mixed with Almond violet oil (10%) ( Tuba Green Gold Company) with the ratio of 5:95 and stir to make homogeneous formulation.
Category
Treatment - Drugs
2
Description
Control group: The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Fateme Seydi
Street address
1nd floor, No 43,Shahid Hajisadehi Avenue, Dardasht Avenue, Narmak
City
Tehran
Province
Tehran
Postal code
1651813911
Phone
+98 21 7793 8493
Email
fateme.seydi1444@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Iranzad asl
Street address
Tehran-Qom Highway Opposite side of Imam Khomeini Holy Shrine Tehran, Shahed University, Department of traditional medicine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
m_iranzadasl@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Fateme Seydi
Position
Phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
1nd floor, No 43, East Shahid Hajisadghi Avenue,Dardasht Avenue ,Narma
City
Tehran
Province
Tehran
Postal code
1651813911
Phone
+98 21 7793 8493
Email
fateme.seydi1444@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Iranzad Asl
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tehran-Qom Highway Opposite side of Imam Khomeini Holy Shrine Tehran, Shahed University, Department of traditional medicine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Email
m_iranzadasl@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Seydi
Position
Ph.D Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
1nd floor, No 43,Shahid Hajisadehi Avenue, Dardasht Avenue, Narmak
City
Tehran
Province
Tehran
Postal code
1651813911
Phone
+98 21 7793 8493
Email
fatemeh.seydi1444@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
After publishing the article
To whom data/document is available
The results will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
After the publication of the article for further and supplementary studies and clinical and therapeutic applications
From where data/document is obtainable
Responsible for public accountability
What processes are involved for a request to access data/document