Clinical Trial Details of World's 1st Homeopathy COVID-19 Study

Homoeopathy as adjuvant in management of Covid-19 infection 

Type of Trial	Interventional
Type of Study	Homeopathy
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Homoeopathy as adjuvant in management of Covid-19 infection
Scientific Title of Study	Effect of adjuvant homoeopathy with standard treatment protocol in management of covid-19: a randomised, open label, placebo controlled, parallel group study

Details of Principal Investigator or overall Trial Coordinator (multi-center study) 

Name	Prof Dr Pradeep Kumar Gupta
Designation	Principal
Affiliation	Naiminath Homoeopathic Medical College, Hospital and Research Centre

Health Condition / Problems Studied

Health Type  Condition  Patients  B972||Coronavirus as the cause of diseases classified elsewhere,

Intervention / Comparator Agent

Type  Name  Details  Intervention  Homoeopathic medicine  Homoeopathic medicines will be given to this group patients as an add-on to standard treatment. Following Individualization medicines will be selected keeping in view pathological aspect of disease. Dose and potency will be according to the frequency, intensity and duration of signs and symptoms. Repetitions will vary from case to case basis considering disease state and vitality of patient. Range of potency from 30, 200, 1M etc will be used.   Comparator Agent  Placebo  Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group.

Inclusion Criteria

Age From  18.00 Year(s) Age To  80.00 Year(s) Gender  Both  Details  o Symptomatic RT-PCR confirmed cases of Covid-19 infection. o Both sexes o Age between 18 years to 80 years and o Willing to give signed written informed consent

ExclusionCriteria

Details  1. Patients requiring ventilatory support 2. Patients with compromised immunity 3. Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases 4. Subjects unable to complete the study, or not suitable for the study by researchers. 5. Women during pregnancy 6. Lactating mothers

Method of Generating Random Sequence

Computer generated randomization

Primary Outcome

Outcome  TimePoints  Clinical outcome in terms of recovery of patient or requirement of life support (ventilator)/ death.  Ever 24 hr.

Secondary Outcome

Outcome  TimePoints  i. Time to progression to critical stage ii. Time to fever clearance iii. Time to resolution of pneumonia iv. Change in severity of symptoms as per clinical syndromes associated with COVID - 19 infection. v. Time to recovery in terms of 2 negative test for Covid-19 vi. Period of hospital stay vii. Requirement of conventional medication till clinical improvement   Ever 24 hr.

Target Sample Size

Total Sample Size="100" Sample Size from India="100"  Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Brief Summary

The results of the study will be able to predict the role of add on homoeopathic treatment for management of Covid-19 infected. In the absence any known anti-viral and vaccine the positive results of this study will decrease the morality and morbidity due to this pandemic. Further the cost-effectiveness of homoeopathy will enable developing countries in controlling such deadly disease effectively.

Source: http://ctri.nic.in/

Complete details of the clinical study