| CTRI Number |
CTRI/2024/11/077446 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of homoeopathic medicine in the treatment of Constipation in Children |
|
Scientific Title of Study
|
A clinical study to evaluate the effectiveness of Calcarea group in the management of Functional Constipation in Paediatric age group using Wexner Constipation Score |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasheda T |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Peadiatrics Opd Room Number 5D
Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8940553055 |
| Fax |
|
| Email |
prashi.murthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K R Binisha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Peadiatrics Opd Room Number 5D
Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8072095009 |
| Fax |
|
| Email |
krbpaediatrician@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K R Binisha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
Department of Peadiatrics Opd Room Number 5D
Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8072095009 |
| Fax |
|
| Email |
krbpaediatrician@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road Seeragapadi Salem Tamilnadu 636308
INDIA |
|
|
Primary Sponsor
|
| Name |
Vinayaka Mission Homoeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main Road Seeragapadi
Salem
Tamilnadu 636308 |
| Type of Sponsor |
Private 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 |
| Dr Prasheda T |
Vinayaka Mission Homoeopathic Medical College and Hospital |
Department of Peadiatrics Opd Room Number 5D
Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main Road Seeragapadi
Salem
Salem
TAMIL NADU |
08940553055
prashi.murthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Mission Kirubanandha Variyar Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High fibre rich diet without medicine |
Education regarding the importance of high fibre rich diet is given and a diet chart will be provided |
| Intervention |
Homoeopathic Remedy with high fibre rich diet |
Intervention of Homoeopathic medicines from Calcarea group based on individualization of the patient along with high fibre rich diet. Based on susceptibility of the patient the dose is selected. Medicine is administered via oral route. Follow up is taken once in a month. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 to 18 years
Children of both sexes
Children fulfilling the criteria for functional constipation based on ICD 11 – DD91.1 and Wexner Constipation Score
|
|
| ExclusionCriteria |
| Details |
Cases related to Metabolic, Neurologic dysfunction and Motility related disorders like Hirschsprung’s disease, spinal cord abnormalities, anterior located anus, hypothyroidism, diabetes mellitus, hypercalcemia.
Children with Immune-compromised Diseases
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wexner Constipation Score |
At the baseline and end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that proposed study will be useful in reducing the symptoms severity of Functional Constipation using the medicine of Calcarea group in paediatric age
group |
At the baseline and end of the study |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Functional Constipation is considered to be one of the major health issues affecting
children in the Paediatric age group and can have detrimental effects on a
child’s life. Although it cannot result in life-threatening difficulties, it can
produce mental and physical disturbances that raise concerns for children and
their families. It can also negatively impact school performance due to a lack
of education, which can eventually lower quality of life when it comes to
health. Constipation has an incidence of 3% affecting people globally, and the mean prevalence of constipation was 9.5%. This
study helps to assess functional constipation using Wexner Constipation scale
and efficacy of Calcarea group in treating it. |