| CTRI Number |
CTRI/2023/04/051596 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
15/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Different treatment of children suffering from worms |
|
Scientific Title of Study
|
Individualized homoeopathic medicines versus standard care in treatment of intestinal nematodes in children: A comparative cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1290-3207 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nibedita Samanta |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7005640692 |
| Fax |
|
| Email |
nibeditasamanta59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Ganguly |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick
Road, Tangra, Kolkata 700046, West Bengal
|
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nibedita Samanta |
D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal |
OPD room no.2 (Pediatrics), 10
(Research), and PG
(Organon of Medicine), Dept.
of Organon of Medicine
Kolkata
WEST BENGAL |
7005640692
nibeditasamanta59@gmail.com |
| Dr Saba Alam |
Panchkari Radharani Adarsha Vidyalaya |
31B, Cristopher Road, Seal Lane, Topsia
Kolkata
WEST BENGAL |
9830675955
saeedayesha33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B820||Intestinal helminthiasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic
medicines plus concomitant
care |
Intervention is planned as administering the indicated homoeopathic medicines in centesimal potencies (cH). 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 with empty stomach; dosage and repetition depending upon the individual requirement of the 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. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Advice will be given to maintain proper hygiene, e.g., regular cleaning of the body every day, washing the hands with soap and water after going to the toilet, washing the hands after handling pet and other animals and trimming of nails. Dosage: As required. Duration of therapy: 3 months. Route of administration: Per oral. |
| Comparator Agent |
Standard care (anti-helminthics, namely, Albendazole, Mebendazole, etc.), plus concomitant care |
Standard care will be provided in terms of anti-helmenthics, namely Albendazole, Mebendazole, etc. in personalized doses, as recommended by consultant pediatrician. In preschool-aged children (2-5 years) (i) 200 mg, (ii) 400 mg and (iii) 600 mg; in schoolchildren (6-12 years) and adults (21 years or more) (i) 200 mg (only for hookworm infections), (ii) 400 mg, (iii) 600 mg and (iv) 800 mg. Advice will be given to maintain proper hygiene, e.g., regular cleaning of the body every day, washing the hands with soap and water after going to the toilet, washing the hands after handling pet and other animals and trimming of nails. Dosage: As required. Duration of therapy: 3 months. Route of administration: Per oral. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients suffering from intestinal nematodes (B82. 0) for 3 months or more
2) Age between 3 and 18 years
3) Patients of either sex, and transgender
4) Literate patients; ability to read English and/or Bengali or illiterate patient will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires.
5) Providing written informed assent and/or consent voluntarily to participate in the trial.
6) The patient reporting to the OPD will be screened for the following symptom and the subject with minimum 5 of the following symptoms will be included in the study.
a) Pain around the umbilics.
b) Pruritus (itching or pain around anus)
c) Hypopigmented patches in skin
d) Pallor
e) Nausea and vomiting
f) Headache
g) Gastric distension
h) Loss of appetite
i) Diarrhea
j) History of passing intestinal nematodes in the stool |
|
| ExclusionCriteria |
| Details |
1) Systemic complications due to intestinal nematodes infestation
2) Acute gastro enteritis
3) Amoebiasis
4) Acute abdomen (appendicitis)
5) Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people
6) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
7) Patients having the history of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
8) Self-reported immune-compromised state
9) Already undergoing homeopathic treatment for chronic disease within last 1 month
10) Simultaneous participation in any other clinical trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients with stool specimen positive for ova-parasites-cysts of intestinal nematodes |
Baseline, after 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Quality of Life (PEDSQL) score |
Baseline, and every month, up to 3 months |
| Reducing symptoms - anal itching and discomfort, passing of gastrointestinal helminths in stool, abdominal pain, nausea, pallor, vomiting, diarrhea, anorexia, unusual irritability, weight loss, headache and pruritus skin |
Baseline, and every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/04/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nibeditasamanta59@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Intestinal parasitic infestation is a major public health problem in children of developing countries. Intestinal parasitic infections are considered amongst the most common infections throughout the world, and it is estimated that 3.5 billion subjects are suffering from it (WHO 1998). Currently, the need for active treatment is controversial. The large number of medicinal alternatives available lack proper evidence to define the best therapy. Though the use of homeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homeopathy in worm infestations has remained compromised. Under such circumstances, we intend to undertake this research project to compare homeopathic medicines with standard of care in the treatment of worm infestations in children and adolescents. A comparative cohort study will be carried out at D. N. De Homoeopathic Medical College and Hospital and Panchkari Radharani Adarsha Vidyalaya, 31B, Cristopher Road, Seal Lane, Topsia, Kolkata 700046 involving 100 children (50 n each cohort) with worm infestation and comparing individualized homeopathic medicines with standard care (anti-helminthic drugs). The primary outcome measure is the difference between groups in proportion of ova-parasites-cysts of intestinal nematodes in stool after 3 months of intervention. Secondary outcome measures will be PEDSQL score and reducing symptoms, assessed every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |