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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 virus”. 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

 
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