| CTRI Number |
CTRI/2024/12/078825 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of immunuty formula in healthy individuals. |
|
Scientific Title of Study
|
Clinical assessment of Immunomodulatory potential of Immunity Formula in healthy individuals- Parallel arm clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/038A Version: 1.00 Dated: 14/10/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner,
Pune 411045, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Life Synergy |
| Address |
office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner, Pune 411045, Maharashtra |
| Type of Sponsor |
Other [[Nutraceutical product promoter]] |
|
|
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 Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
Fourth-floor OPD Lokmanya Hospital, 314/B, Telco Rd, Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: LS/ 24-25/Imm001 |
One Capsule Twice a day after a main meal for 90 days. |
| Intervention |
Group B: LS/ 24-25/Imm002 |
One Capsule Twice a day after a main meal for 90 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged 35 to 60 years (both the ages inclusive) 2. With any one condition prevalent- recurrent upper respiratory tract infection, seasonal asthma, allergic rhinitis, skin allergies 3. Ready to provide written informed consent 4. Subjects with or without the known infection of Covid 19. If known case the Covid 19 infection should not be in the active phase that is within 3 months of infection 5. Subjects with or without vaccinated with SARS Cov 2 vaccine (Any vaccine available in India) 6. No history of any known allergy with herbal products or any of the ingredients of the test product 7. Willing to comply with all requirements of the trial procedure. 8. Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with following criteria Hypertension (140 by 90 mmHg on prescription), Type 2 DM (HbA1C less than or equal to 7.5 on prescription) etc. |
|
| ExclusionCriteria |
| Details |
1. Subject in the active phase of Covid 19 infection or recovered with persistent symptoms or as per discretion of the investigator
2. Patients with known uncontrolled diabetes mellitus (DM) HbA1C more than 7.5 hypertension (HT) symptomatic congestive heart failure (CHF) unstable angina pectoris myocardial infarction (MI)
3. Subjects with a current medical history of any major illness such as cancer, heart disease as per investigator opinion
4. Patients participated in another clinical drug trial within 3 months before recruitment in this trial
5. Any other medical condition that in the Investigators opinion would preclude patient participation
6. Pregnant and breastfeeding women
7. Immunologically compromised individuals
8. Subjects with past history of addiction abuse and rehabilitation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of the Immunity Formula by assessing-
1. Immunity markers- Changes in immunoglobulin IgG and IgM
2. Inflammation markers-Changes in inflammatory markers like CRP, IL-6
3. Antioxidant markers-Changes in antioxidant markers like GSH, CAT, SOD |
1. screening, and 90
2. screening, and 90
3. screening, and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical markers-
1.Change in fatigue severity score
2.Changes in digestive behavior: digestive complaints like bloating, constipation, postprandial fullness, hyperacidity
3.Overall well-being (SF-12 Health Survey)
4.Incidence of subjects presenting with respiratory symptoms during the study
5.Improvement in the immune status based on the adapted Immune status Questionnaire (ISQ) |
1.screening, day 30, 60 and 90
2.screening, day 30, 60 and 90
3.screening, day 30, 60 and 90
4.screening, day 30, 60 and 90
5.screening, day 30, 60 and 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
09/01/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The Immunity Formula, a blend of natural compounds, vitamins, and minerals, has demonstrated promising immunomodulatory effects in healthy individuals. Research indicates its ability to enhance immune resilience by modulating cytokine production, balancing pro-inflammatory and anti-inflammatory responses, and supporting the activity of innate and adaptive immune cells. Clinical studies highlight improved biomarkers of immune function, including increased natural killer (NK) cell activity and optimized T-cell responses. Additionally, its antioxidant properties help mitigate oxidative stress, further supporting immune health. The formula’s benefits suggest it may serve as a preventive measure to maintain immune system balance and overall well-being in healthy populations. |