| CTRI Number |
CTRI/2024/02/063082 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of constipation with constitutional medicine and diet |
|
Scientific Title of Study
|
A prospective randomized control study to show the effectiveness of constitutional medicine in functional constipation among paediatric age group |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinoliyajaini G |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Sarada krishna homoeopathic medical college hospital
Kulasekharam
Department of Paediatrics
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
6382317676 |
| Fax |
04651279448 |
| Email |
dr.vinoliyajaini1617@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bencitha Horrence Mary D |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Sarada krishna homoeopathic medical college hospital
Kulasekharam
Department of Paediatrics
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443064215 |
| Fax |
04651279448 |
| Email |
dr.bencitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P R Sisir |
| Designation |
Professor and head |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Sarada krishna homoeopathic medical college hospital
Kulasekharam
Department of Paediatrics
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
6282615250 |
| Fax |
04651279448 |
| Email |
drsisirpr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic medical college hospital
Kulasekharam Kanniyakumari |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna homoeopathic medical college hospital
Kulasekharam
|
| 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 Vinoliyajaini G |
Sarada Krishna Homoeopathic medical college and hospital |
Department of Paediatrics Kulasekharam Kanniyakumari district
Kanniyakumari
TAMIL NADU |
6382317676
04651279448
dr.vinoliyajaini1617@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna Homoeopathic medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
constitutional medicine |
case is analysed and constitutional medicine will be given for 6 months and improvement is assessed using constipation assessment scale initially and after six months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age group 6 months of age to 18 years of age
Both genders
Children with complaints of difficulty in passing stool with history of 2 weeks.
Children who have experienced two or more symptoms under the Rome’s criteria.
|
|
| ExclusionCriteria |
| Details |
Children undertaking other system of medicines
Cases which have organic etiology such as hirspruchng disaease, colonic obstruction.
Children under 6 months of age and patients above 18 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The improvement of functional constipation is compared with control group and medicinal group |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of functional constipation is compared with control group & medicinal group |
6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 otherwise known as idiopathic constipation. It usually starts after the neonatal period. Functional
constipation is otherwise known as idiopathic constipation. It usually starts after the neonatal period. In
toddler poor toilet training also one of the cause for this. Young children often exhibit stool withholding behaviors which leads to
constipation, pain while passing stool and infrequent bowel motion. Aim of the study is to show the efficacy of individualized homoeopathic medicine in improving the children with functional constipation .Cases will be selected in Sarada Krishna homoeopathic medical college hospital based on the inclusion criteria and improvement is assessed using Constipation assessment scale. |