| CTRI Number |
CTRI/2024/10/075448 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nutraceutical Supplement for Chronic Inflammatory Disorders |
|
Scientific Title of Study
|
Nutraceuticals Supplement for Chronic inflammatory Disorders – Nutrigenomics and Metagenomic Landscape |
| 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 Maya G Pillai |
| Designation |
Principal Investigator |
| Affiliation |
University of Kerala |
| Address |
DHR-ICMR Woman Scientist, Department of Biochemistry, University of Kerala
Thiruvananthapuram
KERALA
695581
India |
| Phone |
09497639589 |
| Fax |
|
| Email |
mayagmitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Helen |
| Designation |
Mentor DHR ICMR Woman Scientist |
| Affiliation |
University of Kerala |
| Address |
Department of Biochemistry
University of Kerala
Kariyavattom Campus
Thiruvananthapuram
KERALA
695581
India |
| Phone |
9447399759 |
| Fax |
|
| Email |
helenabios@keralauniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya G Pillai |
| Designation |
DHR-ICMR Woman Scientist, |
| Affiliation |
University of Kerala |
| Address |
Department of Biochemistry, University of Kerala, Kariyavattom Campus
DHR-ICMR Woman Scientist, Department of Biochemistry, University of Kerala, Kariyavattom Campus
Thiruvananthapuram
KERALA
695581
India |
| Phone |
09497639589 |
| Fax |
|
| Email |
mayagmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001. |
|
|
Primary Sponsor
|
| Name |
Department of Health Research Ministry of Health and Family Welfare Government of India |
| Address |
2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. |
| 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 |
| Dr Maya G Pillai |
University of Kerala |
Room No BCH22, Department of Biochemistry University of Kerala
Kariyavattom Campus
Thiruvananthapuram
Thiruvananthapuram
KERALA |
919497639589
mayagmitra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY LEVEL ETHICS COMMITTEE ON RESEARCH INVOLVING HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PolyNutriBio |
Dose-1g/day
Dose of administration: Oral as capsules
Frequency : Daily
Duration: Three months
|
| Comparator Agent |
Untreated control group |
Participants in the untreated control group will receive no active treatment, placebo, or other interventions during the study period. The untreated control group is included to assess the natural progression of the condition without intervention and to compare outcomes with those receiving the nutraceutical supplement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with no conventional biomarkers for diabetes, atherosclerosis and
arthritis shall be selected from the population belonging to the Thiruvananthapuram district
between the age group of 18-60 years after obtaining informed consent. Anthropological data and
blood samples shall be collected based on routine laboratory procedure. |
|
| ExclusionCriteria |
| Details |
Individuals not belonging to the specified age group, without informed
consent shall be excluded from the study. Individuals with diagnosed with contagious diseases,
chronic illness, cancer or chemotherapy patients shall be excluded from the study. Additionally,
pregnant and lactating women shall be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to assess the efficacy of the nutraceutical mixed polyherbal powder in managing chronic inflammatory disorders. Reductions in the symptoms indicate improvements in disease severity and control, reflecting the effectiveness of the nutraceutical intervention in mitigating chronic inflammation. |
Baseline and 30, 60, 90 and 120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess anti-inflammatory effect after the trial period |
baseline and 30, 60, 90 and 120 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Chronic inflammatory
diseases, encompassing conditions like rheumatoid arthritis, diabetes, atherosclerosis,
non-alcoholic fatty liver disease cancer, etc, present a substantial challenge
to healthcare systems globally due to their persistent inflammation affecting
various organs and systems in the body. Standard treatments, often involving
immunosuppressive drugs, may not adequately control symptoms and can carry
risks of adverse effects.
In this study, we propose
a novel approach to managing chronic inflammatory disorders by developing a
mixed polyherbal nutraceutical powder. Leveraging the synergistic effects of
natural compounds, our formulation aims to address underlying inflammatory processes
while promoting overall health and well-being. Notably, our research considers
the role of gut microbiota in chronic inflammation, recognizing their
significant influence on immune function and inflammatory responses.
Preliminary toxicity and
preclinical studies have demonstrated the safety and effectiveness of our
nutraceutical supplement, facilitating further investigations into its efficacy
in chronic inflammatory disorders in human. Through the dissemination of
knowledge on functional food concepts and healthy living, we aim to empower
individuals with tools for self-care and disease management.
By considering the
intricate interplay between nutrition, gut microbiota, and inflammation, our
study seeks to advance understanding and treatment options for chronic
inflammatory disorders, offering promising avenues for safer and more
sustainable management strategies. Through these efforts, we envision a future
where nutraceutical interventions play a pivotal role in promoting immune
health and mitigating chronic inflammation, ultimately improving the quality of
life for patients worldwide |