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CTRI Number  CTRI/2024/06/068239 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic Treatment of Piles. 
Scientific Title of Study   A double-blind, randomized, study on the efficacy of individualized Homoeopathic medicines in treating Hemorrhoids- a placebo controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1308-5313  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Anjan Roy 
Designation  Reader and HOD, Department of Surgery 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India 
Phone  7610990608  
Fax    
Email  dranjanroy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anjan Roy 
Designation  Reader and HOD, Department of Surgery 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India 
Phone  7610990608  
Fax    
Email  dranjanroy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Anjan Roy 
Designation  Reader and HOD, Department of Surgery 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
The Calcutta Homoeopathic Medical College and Hospital 265-266, APC Road
Kolkata
WEST BENGAL
700009
India 
Phone  7610990608  
Fax    
Email  dranjanroy@gmail.com  
 
Source of Monetary or Material Support  
The Calcutta Homoeopathic Medical College & Hospital, 265,266, APC Road, Kolkata 700009 
 
Primary Sponsor  
Name  The Calcutta Homoeopathic Medical College and Hospital 
Address  The Calcutta Homoeopathic Medical College & Hospital, 265,266, APC Road, Kolkata 700009 
Type of Sponsor  Government medical college 
 
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 Anjan Roy  The Calcutta Homoeopathic Medical College and Hospital  OPD number 3, 16, 19, 21 of Dept of Surgery, Emergency,Medicine, Materia Medica and Organon at 265-266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL 		 7610990608

dranjanroy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Calcutta Homoeopathic Medical College and Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K649||Unspecified hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking placebo with concomitant care  This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy: 3months. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of medicines, potency, and will be dispensed according to the random number list. 
Intervention  Individualized Homoeopathic Medicines with Concomitant Care  Intervention is planned as administering indicated homoeopathic medicines as decided to the case or condition. Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of he cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking, or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. 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® and RADAR® software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy: 3months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i) Age 18-65 years
ii) First degree (grade I) haemorrhoids without prolapse outside of anal canal
iii) Second degree (grade II) haemorrhoids that prolapse with straining, but retract spontaneously
iv) With any of the following clinical symptoms: bleeding, pain (including discomfort and tenesmus during defecation or any other time), heaviness, pruritus, and mucus discharge.
v) Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
vi) Literate patients; ability to read Bengali and/or English and/or Hindi
vii) Patients giving written consent to participate
 
 
ExclusionCriteria 
Details  i) Pregnant or lactating women
ii) Forth degree (grade IV) haemorrhoids
iii) External haemorrhoids
iv) Skin tags
v) Malignancies
vi) Rectal polyps
vii) Anal fissure
viii) Irritable bowel syndrome
ix) Unstable mental or psychiatric illness or other systemic diseases (e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure.
x) Any substance abuses
xi) Self-reported immune – compromised state
xii) Patients who are too sick for consultation
xiii) Simultaneous participation of any other clinical trials.
xiv) Undergoing homoeopathic treatment for any chronic disease within last 6 month.
 
 
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 
Parameters for outcome assessment will be done in Ano-Rectal Symptom Severity and Quality of Life (ARSSQoL) questionnaire with English, Bengali or Hindi version. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being of patients suffering from hemorrhoids.  2 years or till targeted sample size achieved 
 
Secondary Outcome  
Outcome  TimePoints 
To document occurrences of adverse events & Homoeopathic aggravations in all the groups during the trail phase & to shortlist the most frequently indicated Homoeopathic medicines with their indications.  3 months of trial phase 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2024 
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="0"
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 - NO
Brief Summary  
Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just proximal to the dentate line. These vascular cushions are a normal anatomical structure of the anal canal, and their existence does not necessarily indicate haemorrhoidal disease.  Haemorrhoids may be classified into internal haemorrhoids, originating from the internal haemorrhoidal plexus above the dentate line, and external haemorrhoids, originating from the external haemorrhoidal plexus below the dentate line.  
There is quite lack of data available in homoeopathy in treatment of hemorrhoid. keeping in view this lack of validated clinical trial on hemorrhoid, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this double- blind, placebo controlled trial of individualised homoeopathic medicines against placebo at The Calcutta Homoeopathic Medical College & Hospital on 114 participants with hemorrhoids. 
Parameters for outcome assessment in English, Bengali and Hindi version of the ARSSQoL questionnaire. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being patients suffering from haemorrhoids.
 
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