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CTRI Number  CTRI/2020/03/024342 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 12/09/2023
Post Graduate Thesis  Yes 
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 Study to Evaluate the Efficacy of Individualized Homoeopathic Medicines in Treatment of Piles in the Light of Hahnemannian Concept: A Double-blind, Randomized, Placebo-Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1249-0163  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Munmun Koley 
Designation  Postgraduate Trainee 
Affiliation  State National Homoeopathic Medical College & Hospital 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 4, Viraj Khand 1, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  9830816022  
Fax    
Email  dr.mkoley@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinod Kumar Vimal 
Designation  Professor 
Affiliation  State National Homoeopathic Medical College & Hospital 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 4, Viraj Khand 1, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  9532796688  
Fax    
Email  vkvbkh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arvind Kumar Verma 
Designation  Principal, Professor & Head 
Affiliation  State National Homoeopathic Medical College & Hospital 
Address  Dept. of Materia Medica,Viraj Khand 1, Gomti Nagar

Lucknow
UTTAR PRADESH
226010
India 
Phone  7275809725  
Fax    
Email  arvindkr.verma@gov.in  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College & Hospital; Viraj Khand 1, Gomti Nagar, Lucknow - 226010, Uttar Pradesh, India 
 
Primary Sponsor  
Name  State National Homoeopathic Medical College Hospital 
Address  Viraj Khand 1, Gomti Nagar, Lucknow - 226010, Uttar Pradesh, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Munmun Koley  State National Homoeopathic Medical College & Hospital  OPD No. 4, Viraj Khand 1, Gomti Nagar, Lucknow - 226010, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 
9830816022

dr.mkoley@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Intervention  Individualized homoeopathic medicines in centesimal potencies  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided according to the case. In centesimal scale, each dose shall consist of a 6-8 cane sugar globules no.10 medicated with single drop of 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 the cases. Individualized dose will be selected on the judgment of susceptibility of the patients. Subsequent prescriptions will be generated according to Kent’s observations, second prescription, and relevant homoeopathic principles. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with medicines, this arm will be advised to take lifestyle modifications (improving anal hygiene, sitz bath, increase fluid and fibreintake, and avoid straining). In case any acute condition arises, patient will be provided with acute homoeopathic medicine and will be revert back to the previously allocated group once the acute condition settles down. Duration of therapy for each patient is 3 months. 
Comparator Agent  Placebo  This arm, will receive identical looking placebo, indistinguishable in appearnce from verum. Placebo each dose to be taken orally on clean tongue in empty stomach. This group will also be advised to take lifestyle modifications (improving anal hygiene, sitz bath, increase fluid and fibre intake, and avoid straining). In case of any acute condition arises, patient will be provided with acute homoeopathic medicines and will be revert back to the previously allocated group once the acute condition settles down. Duration of therapy for each patient is 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i)Cases suffering from primary piles (ICD K64.9) with or without anitis for at least 3 months
ii)Age between 18 and 65 years
iii)Both male and female patients
iv)Patient having on ongoing standard or other alternative therapy for piles, discontinued for at least 2 weeks
v)Literate patients; ability to read English and/or Hindi and capability and willingness to give informed consent and to comply with the study procedure 
 
ExclusionCriteria 
Details  a)Cases too sick for consultation
b)Cases unwilling to stay after the doctor’s visit
c)Patients unable to read patient information sheet
d)Patients unwilling to take part or not giving consent to join the study
e)Grade IV piles, anal fissure and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies (suspected/diagnosed), history of leukemic disorders, patients with obstruction of portal circulation
f)Cases willing for or requiring immediate surgical intervention or undergoing surgery in last 6 months
g)Diagnosed cases of uncontrolled systemic diseases or life-threatening illness affecting quality of life or any organ failure
h)Patient with psychiatric disorders, unstable mental or psychiatric illness
i)Undergoing homoeopathic treatment for chronic disease within last 6 months
j)Self-reported immune-compromised state
k)Substance abuse and/or dependence
l)Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anorectal symptom severity and Quality of Life Questionnaire (ARSSQoL) score  Baseline, and every month up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
European Quality of Life (EQ-5D-5L)  Baseline, and every month up to 3 month 
Modified Naranjo Criteria  After 3 months 
Patient Response Assessment Tool after Homoeopathic Treatment (PRATHoT)  After 3 months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/04/2020 
Date of Study Completion (India) 30/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet, to be published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Hemorrhoids or piles is the condition where veins of anorectum junction become congested, dilated and elongated, i.e., tortuous. About 3.3 million people of United States are suffering from the fourth leading gastrointestinal disease, i.e., piles, but only 4% seeks medical help. Clinical feature includes fresh bleeding, usually painless until complicated with other disease, history of constipation, due to hanging of overlying mucosa with varicose veins there is partial prolapsed of the rectum. A recent paper reported hemorrhoids as one of the most frequently encountered clinical conditions in a homeopathic hospital surgery and medicine outpatient in West Bengal, India and is treated with a considerable success rate of 60.3 to 82.3%. Treatment options mainly depend on the type and severity of hemorrhoids, patient’s preference, and the expertise of physicians. The current therapies can be grouped into 3 types. Increased fiber intake, medical therapies, and lifestyle changes are included in the conservative treatment for non-thrombosed hemorrhoids. Homeopathy ranks the most popular among the traditional, complementary, or alternative medicines. Thus piles were identified as one of the promising and priority research areas by this systematic documentation research. However, till date, clinical trials in this field have remained seriously compromised. In this double-blind, randomized, placebo controlled trial at State National Homoeopathic Medical College and Hospital, 140 patients suffering from piles will be randomized to either treatment (verum; n=70) or placebo (control; n=70) was aimed to investigate  whether there are any differences in outcomes between these two groups over 3 months of intervention. Anorectal symptom severity and Quality of Life Questionnaire (ARSSQoL), European Quality of Life (EQ-5D-5L), Modified Naranjo Criteria, and Patient Response Assessment Tool after Homoeopathic Treatment (PRATHoT) scores were used as the primary and secondary outcome measures respectively. Out of the 140 randomized, 122 were protocol-compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at P less than 0.05 two-tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (P < 0.001) and EQ-5D-5L VAS (P = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Thus, IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings need to be substantiated by further phase 3 trials.

 
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