| CTRI Number |
CTRI/2019/08/020762 [Registered on: 19/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mitochondria-targeted Pyrroloquinoline quinone (PQQ)can be a potential therapeutic in progressive respiratory diseases. |
|
Scientific Title of Study
|
Microbial origin mitochondria-targeted nutraceutical therapy in progressive respiratory diseases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-409/03/08/2018, GRN 000709 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anant Mohan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No: 3098, Teaching Block, Department of Pulmonary Medicine and sleep Disorders, AIIMS, Ansari Nagar, New Delhi-110029
Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
anantmohan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anant Mohan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No: 3098, Teaching Block, Department of Pulmonary Medicine and sleep Disorders, AIIMS, Ansari Nagar, New Delhi-110029
Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
anantmohan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anant Mohan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No: 3098, Teaching Block, Department of Pulmonary Medicine and sleep Disorders, AIIMS, Ansari Nagar, New Delhi-110029
Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
anantmohan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Council of Scientific and Industrial Research |
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
Library Avenue, Pusa, New Delhi, Delhi 110012 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Prof Anant Mohan |
All India Institute of Medical Sciences, New Delhi |
Department of Pulmonary Medicine & Sleep Disorders, AIIMS, Ansari Nagar, New Delhi
South
DELHI |
9810048204
anantmohan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J60-J70||Lung diseases due to external agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with a clinical and / or radiological diagnosis of COPD and ILD in the Pulmonary medicine OPD and clinics.
• Definition of COPD: (a common preventable and treatable disease characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients). Classification of severity will be done based on GOLD 2018 criteria using spirometry according to ATS / ERS recommendations (2005).
• Definition of ILD: (patients with diagnosis of ILD based on clinical features, spirometry and radiological (HRCT chest) basis. All types of ILD will be included. Adult subjects
|
|
| ExclusionCriteria |
| Details |
1. Patients other diseases such as lung cancer or pulmonary tuberculosis will be excluded from this study.
2. Pregnant women will be excluded from this study.
3. Patients not willing to give consent will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this program is at least one drug candidate (new or repurposed) at an advanced level of development (efficacy in human trial or large animal). The program will also build capacity and enhance scientific understanding of respiratory diseases. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upon successful completion of the project, give a potential therapeutics for respiratory disease like COPD and IPF. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PQQ has been shown to stimulate mammalian mitochondrial biogenesis via a PGC1-alpha dependent pathway. A number of preclinical studies have now found benefits of PQQ in disease models, where mitochondrial dysfunction is known to contribute. By administering this agent, we hope to reduce the rate of decline in lung function in COPD and ILD, which are otherwise relentlessly progressive |