| 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
|
|
|
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
|
|
|
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. |