| CTRI Number |
CTRI/2024/03/063640 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Individualised Homoeopathic Treatment of Chronic Brucellosis in human beings along with Standard Care |
|
Scientific Title of Study
|
Individualised Homoeopathic Treatment of Chronic Brucellosis in human beings along with Standard Care – An open-label, pragmatic, and two arm Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChittaranjan Kundu |
| Designation |
Resaerch Officer,(Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr.Anjali Chatterji Regional Research Institute for Homoeopathy.50 Rajendranath Chatterjee Road. North Twenty four Parganas. WestBengal
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9474543940 |
| Fax |
|
| Email |
dr.kundu1984@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrChittaranjan Kundu |
| Designation |
Resaerch Officer,(Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr.Anjali Chatterji Regional Research Institute for Homoeopathy.50 Rajendranath Chatterjee Road. North Twenty four Parganas. WestBengal
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9474543940 |
| Fax |
|
| Email |
dr.kundu1984@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrChittaranjan Kundu |
| Designation |
Resaerch Officer,(Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Dr.Anjali Chatterji Regional Research Institute for Homoeopathy.50 Rajendranath Chatterjee Road. North Twenty four Parganas. WestBengal
North Twentyfour Parganas WEST BENGAL 700035 India |
| Phone |
9474543940 |
| Fax |
|
| Email |
dr.kundu1984@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional Area, Opposite D
Block, Janakpuri, New Delhi: 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
1-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Chittaranjan Kundu |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
OPD Room no:01, and Research OPD, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, 50 Rajendranath Chatterjee Road.PIN:700035,Near Onkar Petrol Pump North Twentyfour Parganas WEST BENGAL |
03329850232
dr.kundu1984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr.Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A231||Brucellosis due to Brucella abortus, (2) ICD-10 Condition: A233||Brucellosis due to Brucella canis, (3) ICD-10 Condition: A230||Brucellosis due to Brucella melitensis, (4) ICD-10 Condition: A232||Brucellosis due to Brucella suis, (5) ICD-10 Condition: A239||Brucellosis, unspecified, (6) ICD-10 Condition: A238||Other brucellosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Arsenicumalbum
2. Antim Crud
3. Bryoniaalba
4. Baptisia -T
5. Carcinosin
6. Car.V
7. Coff.cruda
8. Thuja. Occ
9. Mag M
10. Camphora
11. Ignatia
12. Rhustoxicodendron
13. Belladonna
14. Nuxvomica
15. Sepia
16. Phosphorus
17. Gelsemium
18. Mag-c
19. Sulphur
20. Natrummuriaticum
21. Aconitumnapellus
22. Eupatoriumperfoliatum
23. Opium
24. Pulsatilla
25. Arsenicumiodum
26. Apismellifica
27. Calcareacarbonica
28. Arnicamontana
29. Baptisiatinctoria
30. Cinchonaofficinalis
31. Lycopodium
32. Dulcamara
33. Influenzinum
34. Oscillococcinum
35. Stannum Met.
36. Camphora
|
Potencies:6C, 30C, 200C, ETC, Potency,
The doses pattern will br6C: Thrice daily 3 DAYS.30C :Twice daily 3 DAYS.200C Once daily.X 3 DAYS, Each dose consist of 6-8 cane sugar globules moisten with the medicine preserved in 90% V/V Ethanol;to be taken orally on clean tongue with empty stomach.
repetition of Homeopathic Medicines as per Homeopathic Principles |
| Comparator Agent |
Doxycycline, 200 mg, gentamicin 3–5 mg/kg/day, rifampin 600–900 mg |
Doxycycline, 200 mg a day orally in 1 or 2 doses for six weeks plus streptomycin 1g intramuscularly or intravenously (i.m./i.v.) once daily for the first 2–3 weeks.
2.Doxycycline in doses and duration as above plus gentamicin 3–5 mg/kg/day i.m./i.v. in 1 to 3 divided doses for 1–2 weeks.
3.Doxycycline in doses and duration as above, plus rifampin 600–900 mg a day orally in one dose for six weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Patients aged between 18 and 60 present with clinical signs and symptoms of recurrent or chronic Brucellosis. (Chronic brucellosis refers to patients whose symptoms persist for 12 months or more from diagnosis and treatment ).
•Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
•Known cases of uncontrolled diabetes hypertension.
•Person with any organic changes CA and others, i.e. tuberculosis, etc.
•Severe condition of the patient in any aspect of health.
•Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptomatic profile of the pateint will be assessed by cured,major improvemnt,moderate improvement,slight improvement,no changes,slight detioration,moderate detioration ,major detioration and diststrous detioration.MYMOP 2 tool to find the improvemnt. |
base line, Every 03 day for first 1 month(09 times),consecutively per month for next 11 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Quality of Life (QoL) using the EQ-5D-5L questionnaire as a parameter to compare and detect differences between two groups. This evaluation will provide valuable insights into the impact of the treatment approach on the overall well-being and quality of life of patients in each group. |
To assess the Quality of Life (QoL) using the EQ-5D-5L questionnaire EVERY MONTH, UPTO 12 TH MONTH.
Using MYMOP Questionnaire every month upto 12th month.
Modified Naranjo criteria every month upto 12th month |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
15/03/2024 |
| 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="2" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.kundu1984@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Brucellosis,
classified among the "seven neglected endemic zoonoses" by the World
Health Organization (WHO), continues to pose significant health concerns,
particularly in regions like Western Asia, the Middle East, the Mediterranean,
and Central and South America. Despite progress in control efforts, its
persistence in areas like Peru, Kuwait, and Saudi Arabia underscores the need
for ongoing monitoring and interventions. Brucellosis, caused by Brucella sp.,
not only affects animals but also poses financial burdens on affected
individuals due to hospital care, pharmacotherapy, and lost income from sick
leave.
The
clinical manifestations of Brucellosis encompass fever, sweats, fatigue,
anorexia, headache, arthralgia, and back pain. Recognizing these symptoms,
exceedingly prolonged fever without an evident cause is crucial for early
diagnosis.
While
the mortality rate is low, timely diagnosis and therapy are critical,
particularly in cases of endocarditis or central nervous system involvement.
Focal disease cases may require intensive therapeutic approaches, including
surgical intervention and extended antibiotic therapy.
Research
into combining homoeopathic treatments with allopathic standard care for
Brucellosis may yield valuable evidence. Well-designed clinical studies can
establish a robust body of evidence, enhancing our understanding and management
of the disease. This integrated approach evaluates the ADD-ON effects of
homoeopathic remedies alongside established allopathic protocols, which may
contribute to evidence-based healthcare practices. The ultimate goal is to
improve treatment strategies for Brucellosis, offering clinicians more
comprehensive options and benefiting patients by potentially enhancing outcomes
and quality of life. This research aligns with a commitment to delivering the
best care through an evidence-backed, integrative approach. |