| 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
|
|
|
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
|
|
|
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. |