Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204600690227 Date of Approval: 06/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPASSIONATE COVID-19 TREATMENT PROJECT INTENDED TO EVALUATE SAFETY AND EFFICACY OF THE NIMRCAF, COVIDOL AND BUPIJI OIL – THE HERBAL PREPARATIONS FOR THE TREATMENT OF COVID-19 PATIENTS
Official scientific title COMPASSIONATE COVID-19 TREATMENT PROJECT INTENDED TO EVALUATE SAFETY AND EFFICACY OF THE NIMRCAF, COVIDOL AND BUPIJI OIL – THE HERBAL PREPARATIONS FOR THE TREATMENT OF COVID-19 PATIENTS
Brief summary describing the background and objectives of the trial The ongoing coronavirus disease of 2019 (COVID-19) epidemic is stretching the health systems and severely impacting the economies of many countries globally. Up-to-date there is no medicine that can treat this disease. Tanzania, like many countries, is fighting the epidemic and different measures are being taken to control the spread of the virus (SARS-CoV-2). However, the prevention measures would probably show better success if they would increase the number of recovered cases of infected, and therefore reducing chances of onward transmission to the unaffected persons. This process can be re-enforced through early enough interventions through using traditional, financially affordable herbal remedies. Here we are proposing a randomized open-label trial intending to assess the safety and efficacy of NIMRCAF, Covidol and Bupiji oil for the treatment of the COVID-19 patients. Objectives Broad Objective The main objective of this study is to assess the safety and efficacy of NIMRCAF, Covidol and Bupiji oil for the treatment of COVID-19 patients. Specific Objectives 1. To determine the safety of NIMRCAF, Covidol and Bupiji oil herbal preparations using clinical and laboratory parameters among COVID-19 patients. 2. To determine the efficacy of NIMRCAF, Covidol and Bupiji oil in terms of clearance of coronavirus and disappearance of the signs and symptoms among patients compared to those receiving standard care alone. 3. To detect and document any adverse event related to the use of each of these three products compared to among those receiving standard care alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HTP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Coronavirus Disease 2019
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/04/2022
Actual trial start date
Anticipated date of last follow up 03/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 416
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NIMRCAF 20mls eight hourly 21 days NIMRCAF is a code name for herbal concoction formulated from five common spices which include ginger roots, red onion bulb, garlic ten big cloves, cayenne pepper and lemon. Most of these ingredients contain antioxidants, immune-boosting properties phytochemicals and some have high flavonoids content. Flavonoids are a class of compounds presented broadly in nature, with extensive profitable biological benefits, including anti-viral/bacterial, anti-inflammatory, cardio-protective, anti-diabetic, anti-cancer, anti-ageing, as well as potential ACE2 inhibitors. 104
Experimental Group Covidol 50mL eight hourly 21 days Covidol is an oral liquid that contains Acalypha fruticos, Fracourtia indica, Keeta venosa and Commiphora africana extracts. These plants possess anti-cancer, anti-tumor, anti-inflammatory, anti-platelet, bronchodilator to mention few effects. Drug can be administered to all cases of Coronavirus Disease. Critically ill patient nasogastric administration is advised. It reduces fever, manages cough, flu and respiratory disorders. 104
Experimental Group Bupiji Oil one drop in 400mls of boiling water inhaled for 5minutes thrice daily 21 days The Bupiji oil herbal oil formulation consists of eucalyptus, lemongrass, cloves, holy basil (tulsi or Ocimum suave), curry leaves, mint and Chenopodium ambrosioides. This oil is used for steam inhalation treatment. 104
Control Group Standard Care for COVID19 It will depend with the drug administered. It will depend with the drug administered. Standard treatment for COVID-19 will be administered to the patients in the control group as per national treatment guideline. 104 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Confirmed COVID-19 patients aged eighteen years and above • Hospitalized and with moderate or severe form of disease, during the study period at any of the study sites • Consented participant • Unconsented participant • Patient with any clinically significant Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale • Patient aged less than eighteen years • Patient with peptic ulcers • History of using any of the investigational herbal preparations • Pregnant women • COVID-19 patients with mild signs and symptoms 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 110 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/01/2022 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the frequency, severity, and duration of adverse events. The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events will be evaluated through study completion. End point
Secondary Outcome NIMRCAF, Covidol or Bupiji oil preparation will be declared to have efficacy on the management of the COVID-19 during the observational period through: • Reduction of number of corona virus as measured CT value • Duration of hospitalization • Duration of clearance of the presenting signs and symptoms • Mortality End point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhimbili National Hospital Malik Road Dar es Salaam United Republic of Tanzania
Muhimbili National Hospital Mlonganzila Kibamba Dar es Salaam United Republic of Tanzania
Kilimanjaro Christian Medical Center Longuo B Moshi United Republic of Tanzania
Bugando Medical Center Makongoro road Mwanza United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Health Mtumba Dodoma United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro Clinical Research Institute Longuo B Moshi United Republic of Tanzania Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Mtumba Dodoma United Republic of Tanzania
Muhimbili National Hospital Malik Road and Kibamba Dar es Salaam United Republic of Tanzania
National Institute for Medical Research 3 Barack Obama Drive Dar es Salaam United Republic of Tanzania
Kilimanjaro Christian Medical Center Longuo B Moshi United Republic of Tanzania
Bugando Medical Center Makongoro road Mwanza United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Godfather Kimaro fatherdk@yahoo.com +255784607461 United Nations road
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania National Institute for Medical Research Muhimbili Center
Role Name Email Phone Street address
Public Enquiries Dorica Burengelo dburengelo@yahoo.com +255713583887 United Nations road
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania National Institute for Medical Research Muhimbili Center
Role Name Email Phone Street address
Scientific Enquiries Godfather Kimaro fatherdk@yahoo.com +255784607461 United Nations road
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania National Institute for Medical Research Muhimbili Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results will be reported after deidentification (through text, tables, figures and appendices). Clinical Study Report,Statistical Analysis Plan,Study Protocol After results are finalized. No end date. Investigators whose proposed use of the data has been approved by the committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information