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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  
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 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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.kundu1984@gmail.com].

  6. 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.

  7. 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.

 
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