| CTRI Number |
CTRI/2025/06/088131 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Individualised Homoeopathic Medicines in Cases of Functional Dyspepsia |
|
Scientific Title of Study
|
To Study the Efficacy of Individualised Homoeopathic Medicines in Cases of Functional Dyspepsia :- A Single Blind, Randomized, Placebo-Controlled Trial |
| 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 Aastik Manojbhai Dandiwala |
| Designation |
PG Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 401 PG Department of Practice of Medicine Jawaharlal Nehru Homoeopathic Medical College,Parul University,Limda, Waghodia ,Vadodara,Gujarat,India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9313109774 |
| Fax |
|
| Email |
aastikdandiwala@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Jadav |
| Designation |
BHMS , MD (HOM.) |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 411 PG Department of Practice of Medicine Jawaharlal Nehru Homoeopathic Medical College, Waghodia ,Vadodara
Gujarat 391760 , India
Vadodara
GUJARAT
391760
India |
| Phone |
9825222758 |
| Fax |
|
| Email |
devendra.javad12677@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Jadav |
| Designation |
BHMS , MD (HOM.) |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Room No 411 PG Department of Practice of Medicine
Jawaharlal Nehru Homoeopathic Medical College,Parul University,Limda, Waghodia ,Vadodara,Gujarat,India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825222758 |
| Fax |
|
| Email |
devendra.javad12677@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College And Hospital ,Parul University,Limda, Waghodia,Vadodara,Gujarat,India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Aastik Manojbhai Dandiwala |
| Address |
Jawaharlal Nehru Homoeopathic Medical College And Hospital ,Parul University,Limda, Waghodia,Vadodara,Gujarat,India 391760 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Aastik Manojbhai Dandiwala |
Jawaharlal Nehru Homoeopathic Medical College And Hospital |
OPD No 110, Department of Practice of Medicine
Vadodara
GUJARAT
Vadodara
GUJARAT |
9313109774
aastikdandiwala@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawharlal Nehru Homoepathic Medical College (Institutional Ethics Committee For Human Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Individualised Homoeopathic Medicine will be Prescribed in Selective Potency as in Required Repetition for 15 Days or as and when it is Required |
| Comparator Agent |
Placebo |
One Group will be Prescribed Placebo And it is Randomized Controlled Trial |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients covering the diagnostic criteria for FUNCTIONAL DYSPEPSIA (ROME IV CRITERIA)
b) Age – 20 to 45 years
c) Gender – both male and female
d) All socio- economic status
e) Willing to give informed consent |
|
| ExclusionCriteria |
| Details |
a) Patients having Organic Gastrointestinal diseases.
b) Patient having IBS (irritable bowel syndrome).
c) Severe psychiatric disorders.
d) Patients with malignancies.
e) Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To See the Role of Individualized Homoeopathic Medicine in comparison with Placebo in Cases of Functional Dyspepsia
2 To Assess the Severity & Outcome of Patients before & after treatment in cases of Functional Dyspepsia by using Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ)
3 To Emerge the Therapeutics of Functional Dyspepsia |
3 Months and Interim Analysis at 1.5 Months, if Necessary |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To Check & Verify the most common age group affected by this condition
2 To Find out the most frequently used Medicines |
3 Months & Interim Analysis at 1.5 Months, if Necessary |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/06/2025 |
| 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
|
The Study is Single Blind , Randomized , Placebo Controlled Trial to Assess the Efficacy of Individualized Homoeopathic Medicine in Cases of Functional Dyspepsia. The Study will be Conducted in 80 participants which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital, Vadodara, Gujarat, India. SF-LDQ Scale will be used for Assessment Purpose. The Study would be Conducted in Time Duration of 1 Year. |