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CTRI Number  CTRI/2024/12/077959 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic treatment of cancer pain 
Scientific Title of Study   Efficacy of individualized homeopathic medicines in LM potencies in addition to standard anticancer care in cancer pain management in adults A series of n of 1 trials using Synthesis Repertory  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1316-1158  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arunabha Aditya 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Repertory OPD room no PG3 12 Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9647842641  
Fax    
Email  arunabha.aditya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shubhamoy Ghosh 
Designation  Professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Pathology and Microbiology OPD room no PG3 12 Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9804151933  
Fax    
Email  shubhamoy67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubhamoy Ghosh 
Designation  Professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Pathology and Microbiology OPD room no PG3 12 Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9804151933  
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 Kolkata 700046 
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 Arunabha Aditya  D N De Homoeopathic Medical College and Hospital  Department of Repertory OPD no. PG3 and 1, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL 		 9647842641

arunabha.aditya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G893||Neoplasm related pain (acute) (chronic),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking placebo and standard care  Placebo identical looking globules will be dissolved in 35 ml of distilled water with addition 2 drops of 90% alcohol and is administered in the same posology as the Verum medication and standard care. Concomitant care: All the enrolled patients will receive advices on general management according to guidelines such as, patient education, to enhance their awareness of fatigue and assessment capabilities; in order to help them find their optimal pace of life. Yoga practices will be advised to the patients as suggested by physiotherapist. Dose: Individualized. Frequency: Individualized. Route of administration: Per oral. Duration of therapy: 2 months 
Intervention  Individualized Homoeopathic medicines and standard care  Individualized homeopathic medication (IHM) following the method of the sixth edition of the Organon is summarized as below: Individualization of the homeopathic medication for each case will be based on analyzing the totality of symptoms. The homeopathic medication will be procured from standardized matrices prepared according to the method described in the sixth edition of the Organon. Intervention is planned as administering individualized homeopathic medicines in 50 millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) will be dissolved in 35 ml distilled water with addition of 2 drops of 90% v/v ethanol; 7 doses 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 rest of the liquid from the cup. All medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)- certified firm. The participant should apply ten succussions to the bottle before each dose (Organon, 6th ed., paragraph 248). As the participant improves, the selected homeopathic medication will be further administered in “step by step” ascending fifty-millesimal potencies (LM1-LM2-LM3-LM4...), wherein each potency will be used for a maximum period of one week. Single individualized medicine will be prescribed on each occasion taking into account presenting symptoms totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia medica and due consensus among three homoeopaths. Provision will be kept to change the medicine or potencies and adjust the dosage whenever required. Concomitant care: All the enrolled patients will receive advice on general management according to guidelines such as, patient education, to enhance their awareness of fatigue and assessment capabilities; in order to help them find their optimal pace of life. Yoga practices will be advised to the patients as suggested by the physiotherapist. Dose: Individualized. Frequency: Individualized. Route of administration: Per oral. Duration of therapy: 2 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients suffering from pain in cancer-related pain (ICD-10 codeG89.3) for at least 3 months.
2. Patients who screen positively for pain (values of 5-6 out of 10 indicating moderate pain).
3. Aged between 18 to 75 yrs
4. Either sex or transgenders.
5. Patients ability to understand Bengali or English or Hindi. 
 
ExclusionCriteria 
Details  1. Patient has NPRS score greater than equal to 7 (severe pain)
2. Patients not willing to cooperate and not giving informed consent to participate in the
trial.
3. Cases too sick for consultation.
4. Cases willing for or requiring immediate surgical intervention or undergoing major surgery in last 6 months
5. Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric
illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
6. Patient with psychiatric disorders
7. Undergoing homoeopathic treatment for chronic disease within last 6 months Substance abuse and/or dependence.
8. Pregnant, in puerperium 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 
SF-MPQ score (Short form McGill Pain Questionnaire)  Baseline, every 10 days, up to 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
EORTC QLQ-C15-PAL (European organization for research
and treatment of cancer quality of life questionnaire core 15 palliative care) 		 Baseline, every 10 days, up to 2 months 
PHQ-9 (Patient Health Questionnaire)  Baseline, every 10 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   N/A 
Date of First Enrollment (India)   16/12/2024 
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)   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 - 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 [arunabha.aditya@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   The International Association for the Study of Pain (IASP) defines pain as an unpleasant emotional situation which is originating from a certain area, which is dependent or non-dependent on tissue damage and which is related to the past experience of the person in question. Chronic pain is common among cancer patients, with about 40% experiencing inadequate pain management. Advances in oncology have improved pain control and increased survival rates, leading to a rise in cancer survivors. However, 27.6% of these survivors suffer from moderate to severe chronic pain, which can last over 3 to 6 months and result from various causes. Chronic pain significantly impacts quality of life, causing physical, emotional, and social challenges. Our aim to study about efficacy of individualized Homoeopathic medicines in the management of cancer pain by using a series of n-of-1 randomized, placebo-control design. Duration of study will be 2 months. Primary outcome SF-MPQ, secondary outcome EORTC- QLQ -C15- PAL, PHQ-9, measured at baseline, every 10 days up to 2 months. Results will be published in scientific journals. 
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