Evaluation of the efficacy of Ipecac homeopathy remedy in controlling covid-19 disease symptoms and accelerating the recovery process
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Patients with covid19 admitted to rasoul-e-Akram and Firoozgar Hospitals are included in the study. Both patient and therapist are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients admitted with suspicious or definite diagnosis of Covid-19(according to national guideline).
Definition of Covid-19 Suspected Case:
A. Patient with respiratory symptoms with radiologic manifestations of unilateral or bilateral multilobular infiltration on CT scan or chest x-ray
B- Pneumoniae person who despite the appropriate treatments, has poor clinical response and in an unusual and unexpected way the patient's clinical condition becomes more acute and aggravated.
Exclusion criteria:
• Patients who are treated with corticosteroids or immunosuppressants for any reason.
• Patients who cannot take oral medication due to decreased consciousness.
Intervention groups
Ipecac homeopathy remedy is prescribed with dose of 15 drops every 2 hours for 6 hours and then 15 drops every 6 hours for 3 days.
Main outcome variables
Fever; Cough; Shortness of breath; Chills; Myalgia; O2 Saturation; Number of days admitted; Number of lymphocytes; Serum CRP level; Ventilator requirement; Oxygen intake and rout of its use and finally side effect of urticaria, itching and eruption.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140907019073N4
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Ali Mazaherinezhad
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
mazaherinezhad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind clinical trial study on Evaluation of the effectiveness of Ipecac homeopathic remedy in control of Clinical manifestations of COVID-19
Public title
Evaluation of the effectiveness of Ipecac homeopathic remedy in control of Clinical manifestations of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suspected or uncertain cases of patients admitted to one of Rasoul-e-Akram or Firoozgar Hospitals with a diagnosis of Covid19 (based on national Guideline).
Exclusion criteria:
Patients should not be intubated.
Patient should not be immune defective.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly patients are divided into moderate and severe groups to match the severity of the disease then according to computerized block randomization division is performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles are numbered in each group and finally according to computerized block randomization division is performed , the remedies and placebo put on the numbered bottles by one of researchers who is only person that know about this concealment. Every patient admitted to the ward and who wants to participate this survey take this bottles respectively.
Patients, therapist and evaluator does not know the true contents of the bottles(which have equal taste and odor) and the study is double-blinded.
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, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-03-26, 1399/01/07
Ethics committee reference number
IR.IUMS.REC.1399.039
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
fever
Timepoint
The first day, the second day, the third day
Method of measurement
Check body temperature with thermometer
2
Description
Cough
Timepoint
The first day, the second day, the third day
Method of measurement
Physician report
3
Description
Shortness of breath
Timepoint
The first day, the second day, the third day
Method of measurement
Patient Report
4
Description
Chills
Timepoint
The first day, the second day, the third day
Method of measurement
Patient Report
5
Description
Myalgia
Timepoint
The first day, the second day, the third day
Method of measurement
Patient Report
6
Description
O2 arterial blood saturation
Timepoint
The first day, the second day, the third day
Method of measurement
Pulse Oximeter Report
7
Description
Number of lymphocytes
Timepoint
The first day, the second day, the third day
Method of measurement
Blood test
8
Description
Serum CRP
Timepoint
The first day, the second day, the third day
Method of measurement
Blood test
Secondary outcomes
1
Description
Need ventilator
Timepoint
The first day, the second day, the third day
Method of measurement
Physician diagnosis
2
Description
The amount of oxygen received
Timepoint
The first day, the second day, the third day
Method of measurement
Manometer view
3
Description
Oxygen Intake Method
Timepoint
The first day, the second day, the third day
Method of measurement
Observation
Intervention groups
1
Description
The one globule of (Ipecac)homeopathy remedy with C30 potency produced by Hellios homeopathy pharmacy distilled in 20 ml. 10 degree alcohol which will be administered at a dose of 15 drops every 2 hours for 6 hours and then every 6hours at 15 drops for 3 days.
Category
Treatment - Drugs
2
Description
The one placebo(Sac-lac) distilled in 20 ml. 10 degree alcohol which will be administered at a dose of 15 drops every 2 hours for 6 hours and then 15 drops every 6 hours for 3 days. remedy and placebo have both common bases and are similar in taste, color, odor and taste.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e- Akram hospital
Full name of responsible person
Ali Mazaherinezhad
Street address
Niayesh St, Satarkhan Av
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 2248
Fax
+98 21 6650 2248
Email
hrmc@iums.ac.ir
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Ali Mazaherinezhad
Street address
Beh Afarin Street , Karim Khan Ave, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Fax
Email
h_firoozgar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Proffessor A.Motevalian
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Fax
+98 21 8670 2503
Email
motevalian.a@iums.ac.ir
Web page address
https://vcr.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
Medical Council of Iran
Full name of responsible person
Farbod Rahnama Chitsaz
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Homeopathy
Street address
No. 119 Shahid Farshi Moqaddam street(16th)
City
Tehran
Province
Tehran
Postal code
1439837953
Phone
+98 21 8413 0001
Email
farbod.chitsaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazaherinezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Hemat Highway next to Milad Tower. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
Mazaheri.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somaye Mahroozade
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 847 Vadat Eslami Street
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
dr.mahroozade@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD collection for the primary and secondary outcomes
When the data will become available and for how long
immediately after publication
To whom data/document is available
people working in academic institution
Under which criteria data/document could be used
The result of further analysis may not be presented to public without permission