| CTRI Number |
CTRI/2019/03/018214 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
10/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Digestive Enzyme ] |
| Study Design |
Other |
|
Public Title of Study
|
Pilot clinical study of Digestive Enzyme. |
|
Scientific Title of Study
|
An Open Label, Pilot Clinical Study on Finding the Effect of a Food Supplement (Enzoveda#001) on Indigestion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MCR/ADVZ/EV/V1.0/CT/002/9102 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Jaiswal |
| Designation |
Homeopathic Consultant |
| Affiliation |
Life Homoeopathy |
| Address |
The Pacific shop no
24 Plot no- 22
Shilp chowk
Sector-13
Mcdonald
Kharghar
Navi Mumbai- 410210
Nil
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9819251333 |
| Fax |
02227562224 |
| Email |
lifehomoeopathy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Sable |
| Designation |
Head of clinical operations |
| Affiliation |
Milagro clinical research |
| Address |
Milagro clinical research
Office no A 61
Balaji Bhavan
Sector 11
CBD Belapur
Navi Mumbai 400614
Nil
Mumbai (Suburban)
MAHARASHTRA
400614
India |
| Phone |
7400407196 |
| Fax |
0222756224 |
| Email |
anjali@milagroclinicalresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikrant Kannojiya |
| Designation |
Clinical Research Associate |
| Affiliation |
Milagro Clinical Research |
| Address |
Milagro clinical research
Office no A 615
Balaji Bhavan
Sector 11
CBD Belapur
Navi Mumbai 400614
Nil
Mumbai (Suburban)
MAHARASHTRA
400614
India |
| Phone |
7400407192 |
| Fax |
0222756224 |
| Email |
vikrant@milagroclinicalresearch.com |
|
|
Source of Monetary or Material Support
|
| Advanced Vital Enzymes Private limited, Thane-400604, India |
|
|
Primary Sponsor
|
| Name |
Advanced Vital Enzymes Private limited |
| Address |
Advanced Vital Enzymes Pvt. Ltd., Lodha Supremus 2, Unit no. 424, 4th floor
Road no 22, Wagle Estate, Thane (West) 400 604, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Milagro Clinical Research |
Milagro Clinical Research
Office no A 615
Balaji Bhavan
Sector 11
CBD Belapur
Navi Mumbai 400614 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Jaiswal |
Life Homeopathy |
The pacific
Shop no 24
plot no 229
Shilp chowk
Sector 13
Mcdonold
Kharghar
Navi mumbai 410210
Mumbai (Suburban)
MAHARASHTRA |
9819251333
02227562224
lifehomoeopathy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Dhanashree Hospital,New Sanghavi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enzoveda#001 |
All eligible subjects who meet the Inclusion and Exclusion will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit) and Day 7
10 subjects will be enrolled.
Subjects in study will receive active Investigational Product and advised to take one sachet three times a day after food
Physical examination and Demographics will be recorded at screening time
Physical examination and monitoring will be continuing on after consumption of Investigational Product till 7 days.
Vitals will be recorded on all visits.
Visual Analogue Scale on all the visits.
(Abdominal discomfort, flatulence, burping or belching, acidity and pain and heaviness in upper abdomen.
will be assessed in each case)
Adverse events will be monitored and recorded up to 7 days. A buffer period of ±2 days will be allowed for every visit and beyond which it will be considered as a protocol deviation.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The Inclusion criteria are as follows (“Yes†to all the following will allow the subjects to be included into study)
1. Age: Adult-Above 18 years to 60 years, both male and female
2. Willing to sign written inform consent
3. Patients diagnosed one of the following signs and symptoms of indigestion
Abdominal discomfort
Flatulence
Burping or belching
Acidity and pain
Heaviness in upper abdomen.
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria are as follows (“Yes†to any one of the following will allow PI to exclude the subject from enrolling into the study
1. Patients below 18 years and above 60 yrs.
2. Not willing to sign written inform consent
3. Allergic reactions to enzymes of similar composition.
4. Gastrointestinal disease or other condition resulting in inability to take oral medications
5. Uncontrolled heart disease or other serious chronic disease
6. Radiotherapy within 4 weeks prior to randomization
7. Patients suffering from chronic major illness, like- Hypertnesion, Jaundice, AIDS, Cancer, Tuberculosis, Diabetes Mellitus, Hepatitis B or C positive etc
8. Use of investigational agents within 4 weeks of randomization
9. Concurrent systemic corticosteroid therapy within 4 weeks of randomization.
10. Seriously ill and moribund patients with complications.
11. Patients unable to comply with the treatment regimen.
12. Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of Enzoveda#001 as a food supplement in patients suffering from indigestion and mean change in Visual Analogue Scale (VAS) from baseline to end of treatment. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief from the symptoms of Indigestion |
7 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2019 |
| Date of Study Completion (India) |
05/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label, pilot clinical study on finding the effect of a food supplement on Indigestion.
The primary objective of this study is to assess safety and efficacy of Enzoveda#O01- as a food supplement in patients suffering from indigestion.
The secondary objective of this study is to assess Relief in symptoms of Indigestion. lt will assessed by Visual Analog Scale {VAS}
All eligible subjects who meet the Inclusion and Exclusion will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit) and Day 7. 10 subjects will be enrolled.Subjects in study will receive active Investigational Product and advised to take one sachet three times a day after food. Demographic data such as Age, Gender, Weight, Vitals will be summarized using descriptive statistics along with Visual Analog Scale.
|