CTRI Number	CTRI/2020/06/026195 [Registered on: 28/06/2020] Trial Registered Prospectively
Last Modified On:	18/11/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Homeopathy
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Homoeopathy as an add-on in treatment of COVID-19
Scientific Title of Study	Effectiveness of Individualized homoeopathy as an add-on to standard treatment of COVID-19 - A multicentric, randomized, parallel arm, single blind, placebo, controlled study
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Debadatta Nayak  Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 South West DELHI 110058 India  Phone  09873404012   Fax     Email  drdnayak@gmail.com
Details Contact Person Scientific Query	Name  Dr Anil Khurana  Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 South West DELHI 110058 India  Phone  09911127619   Fax     Email  anil23101961@gmail.com
Details Contact Person Public Query	Name  Dr Anupriya  Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 South West DELHI 110058 India  Phone  09871139304   Fax     Email  anupriyaccrh@gmail.com
Source of Monetary or Material Support	Central Council for Research in Homoeopathy
Primary Sponsor	Name  Central Council for Research in Homoeopathy  Address  61-65, Institutional Area, Opp. D Block, Janak Puri, New Delhi – 110058  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 2   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Juhi Gupta  Chirayu Hospital  Bhopal-Indore Highway Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh 462030 Bhopal   9425609774 sanjanhvi@yahoo.co.in  Dr Juhi Gupta  Hamidia Hospital  Sultania Road, Bhopal-462001 Bhopal   9425609774 sanjanhvi@yahoo.co.in
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee-CCRH  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent	Type  Name  Details  Intervention  Homoeopathic medicine along with standard care  Homoeopathic medicines will be given to this group patients as an add-on to standard treatmet. 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 cae to case basis cosidering disease state and vitality of patient. Range of potency from 30, 200, 1M etc will be used.  Comparator Agent  Placebo along with standard care  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  1. Hospitalized symptomatic patients with COVID-19 infection 2. Age between 18 years to 80 years 3. Both the sexes 4. Willing to give written informed consent
ExclusionCriteria	Details  1. Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases 2. Patients on ventilatory support 3. Immunocompromised patients 4. Subjects considered to be 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
Method of Concealment
Blinding/Masking	Participant Blinded
Primary Outcome	Outcome  TimePoints  Clinical recovery of patient or requirement of life support (ventilator)/ death.  Ever 24 hr.
Secondary Outcome	Outcome  TimePoints  1. Time to fever clearance 2. Change in severity of symptoms as per clinical syndromes associated with COVID - 19 infection. 3. Time to resolution of pneumonia 4. Time to recovery 5. Period of hospital stay 6. Requirement of conventional medication till clinical improvement   Ever 24 hr.
Target Sample Size	Total Sample Size="300" Sample Size from India="300"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	08/07/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	None yet.
Brief Summary	At present no specific treatment exist for Covid 19. Add on homoeopathy was effective in diseases like Dengue and AES with no reported adverse effects. This study will able to estimate the treatment effect of the add on homoeopathy in covid patients. In the absence any known anti-viral and vaccine any 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.