| CTRI Number |
CTRI/2020/08/027045 [Registered on: 09/08/2020] Trial Registered Prospectively |
| Last Modified On: |
07/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate efficacy and safety of Camphora tablets in Covid positive patients |
|
Scientific Title of Study
|
A randomized, double blind, prospective, placebo-controlled, comparative study to evaluate the efficacy and safety of Camphora tablets when given as add-on therapy to Standard of Care in hospitalized patients who are SARS-CoV-2 positive |
| Trial Acronym |
Camphora in COVID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.1 dated 29 July 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Agarwal |
| Designation |
Additional Professor |
| Affiliation |
TN Medical College and BYL Nair Hospital |
| Address |
OPD Building, ground Floor, Department of Orthopedics, TN Medical College and BYL Nair Hospital, Mumbai Central
Mumbai MAHARASHTRA 400008 India |
| Phone |
9821023866 |
| Fax |
|
| Email |
ashish64kv@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Renuka Munshi |
| Designation |
Additional Professor |
| Affiliation |
TN Medical College and BYL Nair Hospital |
| Address |
G Building, 5th Floor, Department of Clinical Pharmacology, TN Medical College and BYL Nair Hospital, Mumbai Central
Mumbai MAHARASHTRA 400008 India |
| Phone |
02223027204 |
| Fax |
|
| Email |
renuka.munshi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Renuka Munshi |
| Designation |
Additional Professor |
| Affiliation |
TN Medical College and BYL Nair Hospital |
| Address |
G Building, 5th Floor, Department of Clinical Pharmacology, TN Medical College and BYL Nair Hospital, Mumbai Central
Mumbai MAHARASHTRA 400008 India |
| Phone |
02223027204 |
| Fax |
|
| Email |
renuka.munshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| TN Medical College & BYL Nair Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Agarwal |
| Address |
OPD building, ground Floor, Department of Orthopedics, TN Medical College & BYL Nair Hospital, Mumbai |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renuka Munshi |
TN Medical College & BYL Nair Hospital |
G bldg, 5th floor,
Dr AR Nair Road
Mumbai Central
Mumbai Mumbai MAHARASHTRA |
02223027205
renuka.munshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Academic Research Projects (ECARP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Camphora tablets |
Mild infection: Camphora (1M) 4 pills every 4 hours until symptoms abate.
Moderate infection: Camphora (10M) 4 pills every 3 hours until symptoms abate.
Severe infection: Camphora (10M) 4 pills every 2 hours until symptoms abate
To be taken for 10-14 days or till discharge |
| Comparator Agent |
Placebo |
Mild infection: Placebo 4 pills every 4 hours until symptoms abate.
Moderate infection: Placebo 4 pills every 3 hours until symptoms abate.
Severe infection: Placebo 4 pills every 2 hours until symptoms abate
To be taken for 10-14 days or till discharge |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are able to provide a written informed consent or have a legally accepted representative to provide the same.
2.Patients who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test 48 hours prior to the entry into the study.
3.Patients who are admitted with mild / moderate/ severe COVID-19 (as per MOFHW criteria) for treatment at the hospital
4.Female patients with a negative urine pregnancy test at screening.
5.Patients who are able to take the study drug orally and comply with the study procedures |
|
| ExclusionCriteria |
| Details |
1.Patients who are participating in any other clinical trial or experimental treatment for COVID-19.
2.Patients requiring concomitant use of invasive mechanical ventilation.
3.Patients requiring vasopressors or ionotropic medications.
4.Patients requiring anti-viral drugs like ritonavir, lopinavir, remdesivir or monoclonal antibodies like tocilizumab at hospitalization
5.Female Patients who are pregnant or lactating.
6.Patients who are known to be HIV positive or positive for Hepatitis B or C.
7.Patients with liver enzymes (namely alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)) > 5x upper limit of normal.
8.Patients who are not deemed fit as per the investigator for any other medical reason |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This will include determination of the proportion of subjects showing clinical improvement in both the treatment groups |
Day 0, Day 7, Day 14 or Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The determination of change in the clinical improvement scale, resolution of fever by Tmax response, overall survival of the subjects, survival to hospital discharge, progression of COVID-19 associated pneumonitis, number of ICU days, duration of increased supplemental oxygen requirement, change in oxygen requirement, change in cytokine levels and other biomarkers (CRP, CPK, S. Ferritin, LDH, D-dimer levels) and safety and tolerability of Camphora tablets from baseline to end of treatment |
Day 0, Day 7, Day 14, Discharge |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/08/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will publish the data in peer reviewed journal after completion of the study and analysis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 is an infectious disease caused by the “novel corona virusâ€. Common symptoms are fever, dry cough, breathing difficulty. Some patients also have aches and pains, nasal congestion, runny nose, sore throat, nausea, vomiting or diarrhoea. It has been reported from over 200 countries across the world and is associated with a high mortality (0.5 - 8%). COVID-19 disease features range from minor upper respiratory tract infections, mild (fever myalgia) to severe clinical symptoms and even death (Cytokine storm syndrome/cytokine release syndrome to even death). Patients with known corona virus infection have raised IL-6, IL-10, IL-12, IL-14, TNFα and INFg levels, 4-10 days after onset of disease (Huang C. et.al 2020, Ren L et.al 2020). Clinical data from China showed that approximately 17.7% - 32% of patients required intensive care with evidence suggesting that cytokine release syndrome (CRS) plays a major role in COVID-19 disease process (Liu et al, 2020.). There are various Homeopathic medicines claimed to be useful in the present COVID-19 pandemic. The Ministry of AYUSH too has advised use of a Homeopathic Medicine ARS ALB as preventive therapy. However according to the Homeopathic community, there are other medicines that can be effective both as preventive and curative. There are small studies done in Iran, France and England, where they have prescribed Homeopathic medicines and found a positive outcome. Hence we would like to assess the efficacy and safety of an homeopathic medicine viz. Camphora in COVID19 positive patients Camphor has many medicinal uses including serving as an anti-inflammatory, antiseptic, antiviral, bactericidal, counter-irritant, diuretic, expectorant, sedative, stimulant and vermifuge. In dentistry, parachlorophenol [35%] is added to camphor [65%] and used as an antibacterial for infected root canals. Medicinal main constituents Monoterpenes, chiefly camphor, linalool and 1,8-cineole. A white crystalline substance found in cavities in the trunk or obtained by oxidation of the volatile oil, camphor gets its name from the Arabic kafur, chalk. Pockets within the wood may hold crystallised camphor like they were gemstone caves. Camphor is produced by passing steam through the pulverised wood and condensing the vapours. It crystallizes from the oily portion of the distillate and is purified by pressing and sublimation. In its chemical structure, camphor is almost identical to borneol. Synthetic camphor is made from pinene, the principal constituent of turpentine oil. Synthetic camphor can be distinguished from natural camphor by its optical inactivity, the latter being dextrorotatory. Camphora 1M has been used on several patients in Iran and is apparently a coronavirus prophylactic. As a matter of fact, some homeopathy doctors even recommend Camphora 1M as a curative medicine in case of coronavirus although scientific validation of this claim is limited. Camphora, an indigenously manufactured homeopathic drug is an orally administered drug will be potentially useful in the treatment of COVID-19 patients, preventing the progression to the cytokine release syndrome |