CTRI Number	CTRI/2020/05/024969 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On:	28/09/2020
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Homeopathy
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Prof Dr Pradeep Kumar Gupta  Address  N.H.19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh Agra UTTAR PRADESH 283202 India  Phone  9765270885   Fax     Email  nhmcagra@gmail.com
Details Contact Person Scientific Query	Name  Dr Debadatta Nayak  Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 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 Public Query	Name  Dr Anil Khurana  Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 South West DELHI 110058 India  Phone  09911127619   Fax     Email  anilnaman@rediffmail.com
Source of Monetary or Material Support	Naiminath Homoeopathic Medical College, Hospital and Research Centre
Primary Sponsor	Name  Naiminath Homoeopathic Medical College Hospital and Research Centre  Address  N.H.19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh – 283202   Type of Sponsor  Private medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Prof Dr Pradeep Kumar Gupta  F.H. Medical College and Hospital  Near Etmadpur, Railway over bridge, N.H -2 , Agra, Uttar Pradesh - 283201 Agra   9765270885 nhmcagra@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee-F H Medical College  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  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  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
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
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"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India) Modification(s)	15/10/2020
Date of First Enrollment (Global)	15/10/2020
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details
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.