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CTRI Number  CTRI/2024/03/064438 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homeopathic medicines for weakness of cancer  
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in LM potencies in reducing cancer-related fatigue: A series of n-of-1 trials 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1304-5259  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahejabeen Siddique 
Designation  Postgraduate Trainee 
Affiliation  D. N. De Homoeopathic Medical College and Hospital  
Address  Dept of Repertory, OPD room no. PG3 and Oncology, 12 Gobinda Khatick Road kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  9831646077  
Fax    
Email  dr.mahejabeensiddiquee@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Shubhamoy Ghosh 
Designation  Head 
Affiliation  D.N. De Homoeopathic Medical College and Hospital  
Address  Department of Pathology and Microbiology, OPD room no. PG3, 12 Gobinda Khatick Road Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  9831034229  
Fax    
Email  Shubhamoy67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Shubhamoy Ghosh 
Designation  Head 
Affiliation  D.N. De Homoeopathic Medical College and Hospital  
Address  Department of Pathology and Microbiology, OPD room no. PG3, 12 Gobinda Khatick Road Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  9831034229  
Fax    
Email  Shubhamoy67@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046 
 
Primary Sponsor  
Name  D. N. De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road Tangra Kolkata 700046, West Bengal. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahejabeen Siddique  D N De Homoeopathic Medical College and Hosoital  OPD room no. PG3 and Oncology, Dept. of Repertory, 12 Gobinda Khatick Road Tangra Kolkata 700046 West Bengal
Kolkata
WEST BENGAL 		 9831646077

dr.mahejabeensiddiquee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebo plus concomitant care  This group will receive a placebo, identical in appearance to that of verum. A single non-medicated cane sugar globule (placebo) of poppy seed size (no. 10) will be dissolved in 35 ml of distilled water with the addition of 2 drops of 90% v/v ethanol; 7 doses are to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml of normal water in a clean cup, Stir well, take 5 ml of this liquid orally, and discard the rest of the liquid from the cup. All medicines and other items will be procured from a Good Manufacturing Practice (GMP)-certified firm. A diet chart will be given to each participant as advised by a trained dietician, and along with that, a list of yoga poses will also be instructed to all participants as advised by a yoga instructor. Duration of intervention:2 months 
Intervention  Individualized homeopathic medicines in LM potencies plus concomitant care  Intervention is planned as administering the indicated homeopathic medicine in 50 millesimal (LM) potencies. In LM scale, a single medicated cane sugar globule of poppyn seed size (no. 10) will be dissolved in 35 ml distilled water with addition of 2 drops of 90% v/v ethanol; 7 doses are to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard the rest of the liquid from the cup. All the medicines and other sundry items will be procured from a Good Manufacturing Practice certified firm. The patients will be advised to refrain from eating, drinking, smoking, or brushing their teeth within 30 minutes of taking the medicine. A diet chart will be given to each participant as advised by a trained dietician, and along with that, a list of yoga poses will also be demonstrated to all the participants as advised by a yoga instructor. Duration of intervention: 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from cancer-related fatigue (ICD-10 code R53.0) for at least 3 months
2. Patients who screen positively for fatigue (values of 4 out of 10 or higher indicating moderate to severe fatigue)
3. Age between 18 and 75 years
4. Either sex or transgender 
 
ExclusionCriteria 
Details  1. Patients who are not willing to cooperate and are not giving informed consent to participate in the trial.
2. Cases too sick for consultation.
3. Cases willing for or requiring immediate surgical intervention or undergoing major surgery in last 6 months
4. Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illnesses, or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
5. Patients with psychiatric disorders
6. Undergoing homoeopathic treatment for chronic disease within last 6 months
7. Substance abuse and/or dependence
8. Pregnant, puerperal and lactating women
9. Simultaneous participation in any other clinical trial 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)   Every 20 days, up to 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
The Short Form 36 (SF-36) Health Survey Questionnaire  Every 20 days, up to 2 months 
The Wu Cancer Fatigue Scale (WCFS)  Every 20 days, up to 2 months 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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 3 
Date of First Enrollment (India)   01/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 (Others) - 

  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.mahejabeensiddiquee@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    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 - NA
Brief Summary  

Cancer-related fatigue (CRF) is defined as a “distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion, related to cancer or cancer treatment, that is not proportional to recent activity and interferes with usual functioning.” This fatigue is considered to be multidimensional in nature, and a hallmark feature is that CRF is not generally relieved by rest.  CRF may result from the disease itself or from treatments, and it often worsens during the acute treatment timeframe. Estimates of the prevalence of CRF range from 25% to 99%, depending on the type and stage of cancer, type of treatment received. CRF is associated with significant physical and psychological impairments and a decrease in overall quality of life during and after cancer treatment. Homoeopathy may have immense potential to offer in the successful treatment of CRF, but it has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of individualized homoeopathic medicines (IHMs) in the treatment of CRF in adults. A series of double-blind, randomized, placebo-controlled n-of-1 trials will be conducted on 21 adults who are suffering from CRF at the outpatient’s department of D. N. De. Homoeopathic Medical College and Hospital. Assessment will be done by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) score (primary outcome), the Short Form 36 (SF-36) Health Survey Questionnaire, and the Wu Cancer Fatigue Scale (WCFS) score (secondary outcome) every 20 days up to 2 months. Comparative analysis will be carried out to detect group differences. The results will be published in scientific journals.

 
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