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CTRI Number  CTRI/2024/08/072297 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment for post covid respiratory distress  
Scientific Title of Study   A retrospective study to short list the different post covid complications in patient attending NIH IPD and OPD and role of homoeopathic medicine in combating post covid respiratory distress 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Charusmita Priyadarshani 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy,Kolkata 
Address  OPD room no: 14 Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 Kolkata WEST BENGAL 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  9348484129  
Fax    
Email  charusmitapriyadarshani131@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Subhas Singh 
Designation  Professor 
Affiliation  National Institute of Homoeopathy, Kolkata 
Address  OPD room no: 14 Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 Kolkata WEST BENGAL 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Subhas Singh 
Designation  Professor 
Affiliation  National Institute of Homoeopathy, Kolkata 
Address  OPD room no: 14 Department of Organon of Medicine. National Institute of Homoeopathy, GE Block, Sector - III, Salt lake, Kolkata - 700106 Kolkata WEST BENGAL 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  9830644223  
Fax    
Email  drssubhas@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy ,GE Block, Sector- III, Salt lake, Kolkata- 700106 
 
Primary Sponsor  
Name  National Institute of Homoeopathy. 
Address  GE Block, Sector- III, Salt lake, Kolkata- 700106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Charusmita Priyadarshani  National Institute Of Homoeopathy  OPD no.14, Department of Organon of Medicine, GE Block, sector -3, Salt Lake, Kolkata, PIN-700106, WEST BENGAL
Kolkata
WEST BENGAL 
9348484129

charusmitapriyadarshani131@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of National Institute of Homoeopathy.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified, (2) ICD-10 Condition: J989||Respiratory disorder, unspecified, (3) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine in suitable potency  All patients will be prescribed individualized homoeopathic medicine after detailed case taking in accordance with the directions given by Dr. C.F.S Hahnemann in ‘Organon of Medicine’6th Edition. Indicated individualized homoeopathic medicine in suitable potency will be prescribed. Dose and frequency of medicine will be decided as per the homoeopathic principles. Follow up will be done monthly till 6 months from the baseline. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  History of COVID-19 (diagnosed by RTPCR or history of having COVID like manifestations). Patient suffering from respiratory distress which develops after Covid19.Age 18-65 years. Both sexes.
Ability to understand Bengali or Hindi or English.
 
 
ExclusionCriteria 
Details  1.Cases require immediate life support measures.
2.Cases suffering from uncontrolled systemic illness or life-threatening infections or any organ failure.
3.Patients who are too sick for consultation.
4.Unwilling to take part and not giving consent to join the study.
5.Diagnosed cases of unstable mental or psychiatric illness.
6.Pregnant women and lactating mothers
7.Substance abuse and/or dependence.
8.Self-reported immune-compromised state, and
9.Undergoing homoeopathic treatment for any other chronic disease within the last 6 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the changes in intensity and duration of Post Covid respiratory distress after individualised Homoeopathic medication as per the direction of Hahnemann mentioned in Organon of Medicine in §104and §255.  Baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Modified Medical research Council (MRC) dyspnoea Scale
2.Modified Naranjo Criteria for Homoeopathy (MONARCH)  
Baseline and 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After getting approval from the ethical committee, the patients will be approached, and educated   about the study and their consent will be obtained.Following preliminary screening for the complaints develops after Covid 19 using specified selection criteria, eligible 50 patients will be recruited in the study.The study is proposed to be conducted both in IPD and OPD of the National Institute of Homoeopathy, Kolkata and the period of the study will be one year. Our study included patients who were having history of COVID-19 (diagnosed by RTPCR or history of having COVID like manifestations). 50 patients of 18-65 years of age will be included in the study.The patients will be interviewed about whether he/she had History of COVID-19 (diagnosed by RTPCR or history of having COVID like manifestations) and the symptoms remain after they have had COVID-19 has to be noted down.Participants fulfilling the inclusion & exclusion criteria shall be included in the study. Case-taking of the participants will be done as per strict Homoeopathic principles and data as per Preliminary details, special questionnaires and scoring according to the Modified Medical Research Council (MCR) dyspnoea scale and MONARCH. Clinical examination or relevant investigations will be done as per requirement.Medicine will be prescribed in Centesimal or Fifty Millesimal potency, maintaining the strict Homoeopathic principles (regarding dose and repetition).The investigator will be the only authority for collection, recording and assessment of the data.Follow up on a regular basis (every 4weeks) for a minimum of 6 months (In case of50 millesimal before repeating the next potency patient shall consult telephonically). After completion of study the result will be represented by using different statistical methods after analysing the results.

 
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