| CTRI Number |
CTRI/2025/10/096114 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare the effectiveness of individualized homeopathic medicines with lifestyle changes versus placebo with lifestyle changes in patients with gastroesophageal reflux disease (GERD). |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines with Lifestyle Changes versus Placebo with Lifestyle Changes in the Treatment of Gastroesophageal Reflux Disease – A Randomised Crossover Comparative 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 |
Anushree |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no S 21
Department of Materia Medica
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7300827966 |
| Fax |
|
| Email |
anushree23anu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Laroia |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no S 21
Department of Materia Medica
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9312352020 |
| Fax |
|
| Email |
preeti.laroia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no S 21
Department of Materia Medica
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homeopathic Medical College and Hospital
36 B
Knowledge Park
Phase 1
Greater Noida
Uttar Pradesh
201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homeopathic Medical College |
| Address |
Room No G 22
Principal Office
Ground Floor |
| Type of Sponsor |
Private 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 |
| Anushree |
Bakson Homeopathic Medical College and Hospital |
Outpatient Department
Room no 1
Ground Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7300827966
anushree23anu@gmail.com |
| Anushree |
Dr D P Rastogi Central Research Institute |
A 1
Opposite HCL
Sector 24
Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7300827966
anushree23anu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K21||Gastro-esophageal reflux disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines
Pill form of administration |
Oral route of administration
30 pill size
Centisimal scale
First dose after case taking
Repetition of doses according to follow up
Duration of intervention is 6 months |
| Comparator Agent |
Placebo
Pill form of administration |
Oral route of administration
30 pill size
Centisimal scale
First dose after case taking
Repetition of doses according to follow up |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate and provide written informed consent.
Symptoms of heartburn and/or regurgitation for at least 3 months, with at least 2 episodes per week.
GERDQ score below 8 |
|
| ExclusionCriteria |
| Details |
Participants with history of esophageal or gastric malignancy, peptic ulcer disease, gastrointestinal bleeding, or GI perforation
Participants with hypertension, or cardiovascular diseases
Psychiatric patients.
Participants under active medication for GERD or any systemic illness (cardiac, hepatic, renal, pulmonary)
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in GERD symptoms using the GERD questionnaire in both groups. |
Enrollment of cases for 6 months
Follow up period for 6 months
Data analysis for 2 months
Record writing for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the quality of life of patients pre- and post-treatment using WHO-QOL questionnaire |
Enrollment of cases for 6 months
Follow up period for 6 months
Data analysis for 2 months
Record writing for 2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/10/2025 |
| 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="4"
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
|
This study aims to evaluate the effectiveness of individualized homeopathic medicines combined with lifestyle changes compared to placebo with lifestyle changes in managing Gastroesophageal Reflux Disease (GERD). It uses a randomized crossover design where participants receive both interventions in different phases. Outcomes will be assessed using the GERD-Q and WHOQOL-BREF scales to measure symptom relief and quality of life. The study seeks to provide scientific evidence on the role of homeopathy with lifestyle modifications in GERD management Study duration is of 16 months |