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CTRI Number  CTRI/2011/12/002271 [Registered on: 22/12/2011] Trial Registered Prospectively
Last Modified On: 26/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Trial 
Public Title of Study   Adjuvant Homoeopathic Management for side effects from chemotherapy in breast cancer patients  
Scientific Title of Study   Adjuvant Homoeopathic Management for breast cancer patients experiencing side effects from chemotherapy-An observational pilot study  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Kumar 
Designation  Director General In-charge 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Opp. D-Block, Janakpuri New Delhi

South West
DELHI
110058
India 
Phone    
Fax    
Email  ccrhindia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaya Gupta 
Designation  Assistant Director (H) 
Affiliation   
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Opp. D-Block, Janakpuri New Delhi

South West
DELHI
110058
India 
Phone    
Fax    
Email  jgupta21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaya Gupta 
Designation  Assistant Director (H) 
Affiliation   
Address  Central Council for Research in Homoeopathy 61-65, Institutional Area, Opp. D-Block, Janakpuri New Delhi


DELHI
110058
India 
Phone    
Fax    
Email  jgupta21@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional Area, Opp. D-Block, Janakpuri New Delhi-110058  
Type of Sponsor  Research institution 
 
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 DB Sarkar  Dr Anjali Chatterjee Regional Research Institute (H), Kolkata  Room no. 6. 50, Rajendra Chatterjee Road, Kolkata - 700 046 (West Bengal)
Kolkata
WEST BENGAL 
03323282714

drsarkardb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of CCRH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Side effects of chemotherapy in breast cancer patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicines Selection of the medicine will be done after case taking on the basis of presenting totality of symptoms. The prescription shall be justified from Materia Medica or Repertory.   The indicated medicine shall be given in 30c or 200c potency as per the need of the case. Each dose of indicated medicine shall consist of four globules (size no. 30).The effect of homoeopathic medicines shall be observed in managing the side effects of chemotherapy in breast cancer patients. Indicated medicine may be repeated every few minutes to hours depending on the intensity of the symptoms and susceptibility of the patient as follows: 6 hourly- in mild cases 4 hourly- in moderate cases Few minutes to 2 hourly- in severe cases, upto 4 months 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Females, 18 years or over, with any stage of any type of breast cancer undergoing chemotherapy
Patient having any two of the following side effects of chemotherapy viz. nausea, vomiting, abdominal pain, diarrhea, constipation, decreased appetite, hair loss, fatigue reporting within 2 weeks of chemotherapy.
Patient should not be under Homoeopathic treatment for the side effects of chemotherapy
Patients able to take self care
Patients willing to sign written informed consent
Hb% more than 6.5 gm%
 
 
ExclusionCriteria 
Details  Inability to comply with the study protocol, including psychiatric disease
Features of renal failure (urea more than 50 mg%, creatinine more than 2 mg %)
Features of gastro intestinal obstruction
Patients deemed ineligible by the investigator
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Edmonton Symptom Assessment Scale: Revised Version (ESAS-r)  patients will be assessed as per Edmonton Symptom Assessment Scale: Revised Version (ESAS-r)on 3rd and 7th day of homoeopathic treatment after each chemotherapy session. If the patient is not receiving subsequent chemotherapy course, ESES-r is to be filled up every month till 4 months. 
 
Secondary Outcome  
Outcome  TimePoints 
EORTC QLQ-C30 and QLQ-BR23  To assess the Health Related Quality of Life: EORTC QLQ-C30 and QLQ-BR23 at 1st and 7th day of homoeopathic treatment after each chemotherapy session. If the patient is not receiving subsequent chemotherapy course, EORTC QLQ-C30 and QLQ-BR23 is to be filled up every month till 4 months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  
06/08/2012 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary  

An observational pilot study of homoeopathic medicines in combating the side effects of chemotherapy in breast cancer patients will be carried out by Central Council for Research in Homoeopathy, at its Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Kolkata. Female participants 18 years and above, having breast cancer and presenting with side effects of chemotherapy shall be enrolled in the study. Homoeopathic medicines shall be used in the study.  Assessment shall be done as per Edmonton Symptom Assessment Scale (Revised Version), EORTC QLQ-C30 and QLQ-BR23. On conclusion of the study, the data obtained shall be statistically analyzed with the help of a suitable statistical package (SPSS statistical package version 16) to see the usefulness of homoeopathic medicines in combating the side effects of chemotherapy and the results shall be disseminated to the medical fraternity.

 
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