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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- This will include determination of the proportion of subjects showing clinical improvement in both the treatment groups
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •1.Patients who are participating in any other clinical trial or experimental treatment for COVID-
- •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.
结局指标
主要结局
This will include determination of the proportion of subjects showing clinical improvement in both the treatment groups
时间窗: Day 0, Day 7, Day 14 or Discharge
次要结局
- 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)
