| CTRI Number |
CTRI/2022/12/048631 [Registered on: 30/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to Compare the Safety and Effectiveness of Digifine Capsule and Pantoprazole plus Domperidone or Pantoprazole versus Pantoprazole plus Domperidone and Pantoprazole in Patients with Functional dyspepsia |
|
Scientific Title of Study
|
A Prospective, Randomized, Open-label, Parallel-group, Investigator-initiated Study to Evaluate and Compare the Safety and Effectiveness of Digifine Capsule coadministered with FDC of Pantoprazole plus Domperidone or Pantoprazole versus FDC of Pantoprazole plus Domperidone and Pantoprazole in Management of Patients with Functional dyspepsia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjana G Deshmukh |
| Designation |
Consultant Physician |
| Affiliation |
Dr. Hedgewar Rugnalaya |
| Address |
Room no. 2031, Ground Floor, OPD Department, Dr. Hedgewar Rugnalaya, Garkheda,
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
02402245000 |
| Fax |
|
| Email |
drranjana.dhr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana G Deshmukh |
| Designation |
Consultant Physician |
| Affiliation |
Dr. Hedgewar Rugnalaya |
| Address |
Room no. 2031, Ground Floor, OPD Department, Dr. Hedgewar Rugnalaya, Garkheda,
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
02402245000 |
| Fax |
|
| Email |
drranjana.dhr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana G Deshmukh |
| Designation |
Consultant Physician |
| Affiliation |
Dr. Hedgewar Rugnalaya |
| Address |
Room no. 2031, Ground Floor, OPD Department, Dr. Hedgewar Rugnalaya, Garkheda,
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
02402245000 |
| Fax |
|
| Email |
drranjana.dhr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Macleods Pharmaceuticals Ltd.
Research & Development Centre III, Plot no: 18, Road no-09, Marol MIDC,
Andheri (East), Mumbai, Maharashtra - 400093
|
|
|
Primary Sponsor
|
| Name |
Dr Ranjana G Deshmukh |
| Address |
Room No. 2031, Ground Floor, Dr. Hedgewar Rugnalaya, Garkheda, Aurangabad, Maharashtra 431005 |
| Type of Sponsor |
Other [Self] |
|
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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 Ranjana G Deshmukh |
Dr. Hedgewar Rugnalaya |
Room no. 2031, Ground Floor, OPD department, Garkheda
Aurangabad
MAHARASHTRA |
02402245000
drranjana.dhr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. BAMRS Dr. Hedgewar Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
Digifine 40 mg Capsules |
1 capsule three times daily before food for 30 days |
| Comparator Agent |
FDC Pantoprazole 40 mg plus Domperidone 30 mg Sustained Release Capsule |
1 capsule once daily before food for 30 days |
| Comparator Agent |
Pantoprazole Tablet, 40 mg |
1 tablet three times daily before food for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female patients between 18 to 60 years (both ages inclusive)
2. Patients with functional dyspepsia as per ROME IV criteria and currently not receiving any treatment since at least two weeks prior to screening (ROME IV criteria can be referred)
3. Patients had an upper endoscopy performed within 3 months before screening that showed no evidence of structural disease that was likely to explain the dyspepsia symptoms.
4. Patients willing to give their written informed consent to participate in the study and able to record answers on study-related questionnaires
5. Patients willing to comply with all aspects of the protocol |
|
| ExclusionCriteria |
| Details |
1. Patients hypersensitive to active or inactive ingredients of investigational products
2. Patient with history of taking medicines responsible for QT prolongation
3. Patients with history of cardiac disorder (clinically significant bradycardia, sinus node dysfunction, prolonged QTc, cardiac conduction intervals, history of arrhythmia or at risk of serious ventricular arrhythmias)
4. Patients with history of clinically significant hepatic dysfunction, renal insufficiency, electrolyte disorders, which in the opinion of the investigator might affect patient‟s safety while participating in the study or affect study treatment result analysis
5. Patients with history of gastrointestinal hemorrhage or obstruction or having any symptoms suggestive of gastrointestinal hemorrhage or obstruction or prolactinoma
6. Patients who have history significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure, hepatic diseases or renal disease as per investigator‟s judgment may impact the efficacy analyses for the study or put the Patient‟s safety at risk based on prescribing information of pantoprazole and/or domperidone
7. Female patients who are pregnant, lactating, or planning to become pregnant
8. Patients (male and female both) not willing to use acceptable method of contraception
9. Patients scheduled to undergo surgery during the study period
10. Patients who have received any intervention in a clinical trial within 01 month prior to screening
11. Patients with history of alcohol or substance abuse which as per Investigator"s which may interfere with safety of patients or treatment evaluation while participating in the study
12. Current significant alcohol consumption or smoking tobacco based on investigator"s evaluation of patient"s lifestyle which may interfere with safety of patients or treatment evaluation while participating in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage change in global overall symptom scale on Visit 2/Day 15 (±4days) days of treatment from baseline as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B)
2. Percentage change in global overall symptom scale on Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14 as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B) |
1. Visit 2/Day 15 (±4days) days of treatment from baseline
2. Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with adequate relief on Visit 2 and Visit 3 from baseline as assessed by total symptom score recorded under functional dyspepsia diary questions
Adequate relief defined as more than 50 percent reduction in the total symptom score based on functional dyspepsia symptom diary |
Visit 2 and Visit 3 from baseline |
| Proportion of patients with adequate relief on Day 7 and Day 21 period from baseline |
Day 7 and Day 21 period from baseline |
| Proportion of patients with decrease in severity of each symptom score assessed from functional dyspepsia symptom diary on Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24 from baseline |
Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dyspepsia is a common disease that accounts for ~5% of patients who visit their primary health care provider and functional dyspepsia (FD) accounts for 60-80% of all patients with dyspepsia (Jung HK et al., 2016). The FGID with upper abdominal pain and discomfort is the hallmark feature of functional dyspepsia. One of the unique features of functional dyspepsia is transient deficiency of digestive enzymes in the system. The global prevalence of FD varies from 11-30%, and Indian prevalence is reported to be 30.4% (Soni NK et al., 2020).
Digestive enzyme supplementation are from the natural source and required by the body to metabolize and digest complex food to prevent indigestion and for better GI heath. Some conditions (such as diarrhoea, constipation, dyspepsia, etc.) can change the normal balance of bacteria (flora) found in the stomach and intestines. For better improvement of digestion and restoring normal gut flora; probiotics are beneficial. Digestive enzymes and probiotics are essential for normal digestive function. The addition of probiotics to enzymes helps promote a healthy intestinal tract environment. Combination of digestive enzymes and probiotics exhibits beneficial action in metabolism and utilization of nutrients. Probiotics with digestive enzymes have been used to prevent bowel symptoms (such as gas, bloating, abdominal discomfort, etc.) and to treat lactose intolerance. Thus, the combination of digestive enzyme and probiotics would help in digestion and restore the normal flora which in turn would also aid digestion. Together, the combination would be useful in relieving GI discomfort as seen in dyspepsia, constipation, diarrhoea, lactose intolerance, etc. and thereby may even prevent IBS. (Soni NK et al., 2020). Thus, the combination of digestive enzyme and probiotics like Digifine capsule along with PPIs or prokinetics may facilitate in better relief to patients with functional dyspepsia. |