| CTRI Number |
CTRI/2019/09/021019 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
28/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety evaluation of OLNP-06 in Subjects with Functional Dyspepsia. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Functional Dyspepsia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLS/OLNP/06/07/19, Version 1.0, Dated 17th July 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
Biosite Research Private Limited
#740, 2nd Floor, 14th Main Road,
Kumarswamy Layout Stage 1, Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
080-26667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Kumar Panda |
| Designation |
Chief Operating Officer |
| Affiliation |
Olene Life Sciences Pvt. Ltd. |
| Address |
Olene Life Sciences Pvt. Ltd., India, A Block,4th Floor ,Prince
Info Park, 81 B,2nd Main Road (Opp Ambit Park), Ambattur
Industrial Estate, Chennai,Tamil Nadu,India
Chennai
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
info@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Kumar Panda |
| Designation |
Chief Operating Officer |
| Affiliation |
Olene Life Sciences Pvt. Ltd. |
| Address |
Olene Life Sciences Pvt. Ltd., India, A Block,4th Floor ,Prince
Info Park, 81 B,2nd Main Road (Opp Ambit Park), Ambattur
Industrial Estate, Chennai,Tamil Nadu,India
Chennai
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
info@olenelife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Private Limited
A-Block, 4th Floor, Prince Info Park,
81 B, 2nd Main Road (Opp Ambit Park),
Ambattur Industrial Estate,
Chennai-600058, Tamil Nadu
|
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
A-Block, 4th Floor, Prince Info Park, 81 B, 2nd Main Road (Opp Ambit Park), Ambattur Industrial Estate, Chennai-600058, Tamil Nadu
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vivek Bhatia |
Maharaja Agrasen Hospital |
Department of Gastroenterology, 4th Floor, Maharaja Agrasen Hospital, West Punjabi Bagh
New Delhi
DELHI |
01140777744
dr.vivekbhatia@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| tnstitutional Ethics Commiffee |
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 |
OLNP-06 200 mg capsule |
OLNP-06 200 mg capsule should be taken twice daily orally before food for a period of 28 days. |
| Comparator Agent |
Placebo 200 mg capsule |
Placebo 200 mg capsule should be taken twice daily orally before food for a period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects age 18 - 55 years.
2. Diagnosis of functional dyspepsia, Postprandial distress Syndrome by fulfilling Rome-III criteria
3. Subjects with at least one of the following two for at least 6 months
i)Post prandial fullness
ii)Early satiety
or
Subjects with two or more of the following symptoms at a moderate or severe level within the previous 03 months (At least one symptoms of postprandial fullness, upper abdominal bloating or early satiety should be included)
i)Upper abdominal pain
ii)Upper abdominal discomfort
iii)Post Prandial fullness
iv)Upper abdominal bloating
v)Early satiety
vi)Nausea
vii)Vomiting
4. Female Subjects of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test.
5. Written informed consent signed by patient and willing to comply with the study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating female patients.
2. Subject having heartburn as the most bothersome symptom or if they had moderate or severe heartburn during the baseline period.
3. History of peptic ulcer or gastro esophageal reflux disease (GERD).
4. Current prominent symptoms of irritable bowel syndrome.
5. Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy.
6. Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors and prokinetics in the preceding two weeks.
7. Participation of other clinical trials within the last 1 month.
8. Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
9. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
10. Patient with known history of hypersensitivity to any ingredient of investigational product. Any medical condition deemed exclusionary by the Principal Investigator.
11. Subject has a history of drug and / or alcohol abuse at the time of enrolment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall Treatment efficacy (OTE) |
Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Elimination rate (score 0) of all three major symptoms
|
Screening, Day 14 and Day 28 |
| Elimination rate for each individual Symptom |
Screening, Day 14 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
02/09/2019 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Functional dyspepsia is a clinical syndrome that is characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of underlying organic disease that can explain the symptoms. Pharmacological therapy for patients with functional dyspepsia remains unsatisfactory. In addition to poor efficacy, pharmacological agents are associated with a risk of adverse effects. Herbal medicine might be an attractive alternative based on the perception of its natural approach and low risk of adverse effects.Thus OLNP-06 as a ginger extract powder with standardises to high percentage of Gingerol may fulfil the unmet needs of Indian subjects suffering from FD. Hence this study is being conducted to evaluate efficacy and tolerability of OLNP-06 compared to placebo for the treatment of functional dyspepsia in Indian population.
|