| CTRI Number |
CTRI/2024/12/078730 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in managament of cases of GERD in Bilious temperament |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in management of cases of GERD with particular emphasis on Bilious temperament: A prospective single arm clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kushal |
| Designation |
Junior Resident (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy, Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South
DELHI
110024
India |
| Phone |
9958917207 |
| Fax |
|
| Email |
kushal19121994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Jethani |
| Designation |
HOD (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy, Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South
DELHI
110024
India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kushal |
| Designation |
Junior Resident (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy, Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South
DELHI
110024
India |
| Phone |
9958917207 |
| Fax |
|
| Email |
kushal19121994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024 |
| 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 |
| Dr Kushal |
Nehru Homoeopathic Medical College and Hospital |
Department of Homoeopathic Philosophy, Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South
DELHI |
9958917207
kushal19121994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Of Nehru Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic individualized medicine in centesimal scale from group of bilious temperament remedies |
40 patients will be enrolled
and homoeopathic individualized medicine in centesimal scale after considering the bilious temperament will be given after repertorisation from group of bilious temperament remedies and consultation with homeopathic materia medica and follow up of each patient will be taken every month for three months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and female patients between age group 18–60 years having symptoms of heartburn and/or regurgitation with at least 1 episode in a week and symptom score more than 4 on GERDQ.
2) Patient having bilious temperament on the basis of temperament questionnaire.
3) Patients willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patients falling under other temperaments as per questionnaire.
2) Patients with advanced pathology of GERD.
3) Substance abuse or dependence.
4) Patients already taking acid-suppressing medications like proton pump inhibitors (PPIs) and histamine H2 receptor antagonists.
5) Patients of malignancy.
6) Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
7) Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illness affecting quality of life/any organ failure.
8) Patient unable to comply with the study protocol (including psychiatric diseases).
9) Pregnant ladies are excluded.
10) Unwilling to take part and not giving consent to join the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction of clinical symptoms of GERD using GERDQ scale |
Baseline and at every month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify useful homeopathic medicines for management of GERD in bilious temperament. |
At 1 year |
| To identify the most commonly indicated medicine in management of GERD in bilious temperament. |
At 1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/01/2025 |
| 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="0"
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
|
Gastroesophageal
reflux disease (GERD) is a prevalent health issue resulting from the backflow
of stomach contents into the esophagus due to a malfunctioning lower esophageal
sphincter (LES). This reflux can cause uncomfortable symptoms
such as heartburn and regurgitation, and over time, may damage the esophageal
lining due to acidic exposure. Research question- Is there any significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament. Null hypothesis- There is significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament. Alternative hypothesis- There is no significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament. Aim- To study effectiveness of individualized homoeopathic medicines in management of cases of GERD in bilious temperament. Primary objective- To evaluate effectiveness of individualized homoeopathic medicines in management of cases of GERD in bilious temperament using GERDQ scale. Secondary objective- 1) To identify useful homoeopathic medicines for management of GERD in bilious temperament. 2) To identify most commonly indicated medicine in management of GERD in bilious temperament. Source of data- Out patient department of Nehru Homoeopathic Medical College and Hospital Study duration- 1 year Study design- Open label, prospective, single arm clinical study Sample size- 40 |