300 people covid placebo-controlled clinical trial

A randomized, placebo-controlled trial of adjunct homeopathy with standard of care for COVID-19 was conducted on 300 patients in a hospital environment. India Chirayu hospital

• Primary outcome on total symptom score measured over 10 days decreased significantly favoring Standard of care + Homeopathy.

• Recovery was earlier in Standard of care + Homeopathy group by 02 days showing the added benefits of homeopathy.

• Resolution of fever was 20 hours earlier in Standard of care + Homeopathy SC+H

• The study was conducted between July 2020 and October 2020.

• Patients who were reverse transcription polymerase chain reaction (RT-PCR) positive for SARS-CoV-2 and admitted to the COVID-19 ward of Chirayu Hospital were screened for study eligibility. Symptomatic patients aged 18–80 years, both sexes, willing to give written informed consent were included in the study

• All patients received supportive care according to the standard of care of the hospital as per the prevailing recommendation of the state government for COVID-19. It consisted of azithromycin 500 mg (once daily), pantaprazole 40 mg (once daily), calcium 500 mg (twice daily), Montelukast 10 mg/Levicetirizin 5 mg (once daily, during hours of sleep), Zinc 50 mg (once daily), vit D3 60000 IU (weekly). This regimen of standard care was given for 5 days. However, this protocol was modified as per the requirement and patient prognosis. Medicines were also given for symptomatic management of cough and pain, etc. as per the symptoms of the patient. Anti-hypertensive, anti-diabetic and others were given to patients as per the need of the individual case.

• Of the 300 consenting adults there were N=151 in the SC+H group and N=149 in the placebo group SC+P

Each symptom’s severity was measured on a 10-point numerical rating patient-reported scale. The patients were asked by the homeopathic treating physicians to rate their symptoms experienced over the past 24 h, 0 being no symptom to 10 being the worst suffering from the symptom imaginable. The score of each symptom was added to get the total symptom score for each patient. The outcome was assessed every day between 8 a.m. and 12 noon.

The secondary outcomes were time to fever clearance and time to clinical recovery. Time to fever clearance was defined as the time from the first dose of the study drug until the temperature dropped to ≤37.5 °C and remained below this temperature for at least 48 h. The body temperature of patients was recorded every 6 h. Time to clinical recovery was the time from enrolment till the total symptom score became ‘0’.

Assuming a 10% withdrawal rate, a total of 305 patients were needed for enrolment

The homeopathic medicines were dispensed through medicated sucrose pills; similarly, the placebo group received sucrose pills impregnated with ethyl alcohol. Both medicated and placebo pills were identical in colour, odour, and appearance.

The symptoms (dyspnoea, sputum production, fatigue, cough, headache) which were frequently associated with adverse outcomes in COVID-19 patients were analyzed for the percentage of patients getting relieved from them. The day-wise cumulative percentage was calculated for the no. of patients who had resolution of each pathogonomic symptom. A P value less than 0.05 was considered statistically significant

The most common comorbidity was hypertension followed by diabetes mellitus and chronic lung disease. At the time of enrolment 62.91% (n = 95) had pneumonia in the SC + H group, while 51% (n = 76) had pneumonia in the SC + P group. Among all the patients, 1.39% (n = 2) had oxygen saturation below 90%, 27.27% (n = 39) had between 90% and 95% in the SC + H group and 3.54% (n = 5) had oxygen saturation below 90%, 28.36% (n = 40) had between 90%–95% in the SC + P group. The patients were classified into mild, moderate, and severe as per the presentation at baseline.

Outcome

After 5 days of treatment, a significant number of patients in the SC + H group got rid of symptoms. Placebo being /SC+P. The cumulative percentage of patients getting relieved of symptoms is as follows (SC + H/SC + P): dyspnoea 60.66%/29.73%; sputum production 85.29%/21.05%; fatigue 68.57%/21.82%; cough 64.63%/33.33%; headache 84.09%/78.13%.

Our study found that adjunct individualized homeopathic medicine with the standard of care significantly improves clinical recovery with early resolution of symptoms compared to those who received placebo along with the standard of care. This study is the first of its kind with adjunct individualized homeopathic treatment of COVID-19.

About 82% of post-COVID-19 patients reported suffering from at least one symptom related to COVID-19 [21]. In our study in the standard care group, 63% had at least one symptom at the time of discharge from the hospital. However, in the adjunct treatment group, only 24% of patients had any residual symptom related to COVID-19 at discharge from the hospital.

Adjunct homeopathy could significantly shorten the time for fever clearance, thereby reducing the need for antipyretics. It has been reported that symptoms such as dyspnoea, sputum production, fatigue, and headaches are frequently observed in patients with fatal outcomes [22]; however, in our study, these symptoms resolved earlier in patients who received adjunct homeopathy than in those who received standard of care only.

Symptoms related to pneumonia were resolved earlier in the SC + H group than in the SC + P group.

Due to the large number of COVID-19 patients during the study at the hospital, the follow-up laboratory tests of all the patients could not be done due to a resource crunch. However, this does not limit the applicability of the study results as clinical improvement is evident from an early resolution of symptoms of the patients.

The no. of moderate/severe (based on the presence of pneumonic changes in the lung) cases and patients having higher total symptom scores at baseline were more in the SC + H group, however there were more in the homeopathic group than the placebo group in chronic lung cases.

The study was created by homeopaths;

Debadatta Nayak a, Juhi Gupta b, Anupriya Chaudhary c, Krishna  Gopal Singh d, Abhijeet Deshmukh e, Deblina Das a, Abhishek Saha f, Deepak Kumar a, Ashwini Kumar a, Ajay Goenka g, S.K. Mishra h, Sanjay Gupta i, Anil Khurana j