| CTRI Number |
CTRI/2023/05/052481 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A randomized, double-blind, placebo-controlled, parallel study with an open label placebo extension |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, study to assess the immunomodulatory effect of the Gingeride in adults; A pilot study with an open label cross-over extension. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0081-008/ Version 1.0/ Dated 13 February 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana Murthy |
| Designation |
Consultant General Medicine |
| Affiliation |
Vagus Super Speciality Hospital |
| Address |
Vagus Super Speciality Hospital, Room 4, No 6, 7 and 8, 18th cross, 4th main, Malleshwaram west, Bengaluru
Vagus Super Speciality Hospital, Room 4, No 6, 7 and 8, 18th cross, 4th main, Malleshwaram west, Bengaluru
Bangalore
KARNATAKA
560055
India |
| Phone |
7259214727 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujay Gowda |
| Designation |
Head Clinical Development |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building No 06, 3rd and 4th floor,2nd Main Rd, Sarvobhogam Nagar, Arekere, Bengaluru
Landmark: Opposite to British Biologicals
Bangalore
KARNATAKA
560076
India |
| Phone |
9110224495 |
| Fax |
|
| Email |
sujay.gowda@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
VP-Business Operations |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building No 06, 3rd and 4th floor,2nd Main Rd, Sarvobhogam Nagar, Arekere, Bengaluru
Landmark: Opposite to British Biologicals
Bangalore
KARNATAKA
560076
India |
| Phone |
9742172953 |
| Fax |
|
| Email |
subham.dutta@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Vagus Super Speciality Hospital
No 6, 7 and 8, 18th cross, 4th main, Malleshwaram west, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Herbs Pvt Ltd
#14A, KIADB Industrial Area,
Jigani 1st Phase, Bangalore – 560105. INDIA |
| Type of Sponsor |
Other [Health Functional Food] |
|
|
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 Meghana Murthy |
Vagus Super Speciality Hospital |
Room 4, No 6, 7 and 8, 18th cross, 4th main, Malleshwaram west, Bengaluru Karnataka - 560055
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
In general good health with BMI ≤ 30 kg/m2. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gingeride |
Participants will receive Gingeride for the first 30 days. After unblinding, participants receiving Gingeride for the first 30 days will continue to receive the same for the next 30 days while participants receiving the placebo will be receiving Gingeride for the next 30 days of the study. |
| Comparator Agent |
Placebo |
Participants will receive placebo for the first 30 days of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 18-35 years (inclusive of both the ages) with a BMI of ≤ 30 kg/m2.
2. Participants generally in good health status as confirmed by investigator based on clinical history, physical exam, and routine blood analysis.
3. The participant must not have taken any vitamin/mineral/dietary or herbal supplements, 1 month prior to enrollment in the study.
4. Participant must be able & willing to comply with study procedures.
5. Participant willing to sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
2. Diagnostic history of any allergies.
3. Intention to use any vitamins and/or minerals and/or dietary and/or herbal supplements during the study period.
4. Participants with the diagnostic history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease
5. Participants who had undergone any surgery during last one year.
6. With the history or planning organ transplantation.
7. Smokers and alcohol/drug abuse
8. Pregnant& lactating women.
9. Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
10. Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
11. Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline value of Th1 (interferon-γ) and Th2 (interleukin-4) between groups.
2. Change from baseline values of Immunoglobulin (IgG, IgM, and IgA) levels between groups
3. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) |
1. Day 1 (Baseline), Day 30, and Day 60
2. Day 1 (Baseline), Day 30, and Day 60
3. Day 1 (Baseline), Day 30, and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hematology and Biochemistry
2. Occurrence of any AE or SAE |
1. Screening, Day 30, and Day 60
2. Throughout the study |
| To evaluate the efficacy among the active group for the extended treatment duration in terms of change in Th1 (interferon-γ), Th2 (interleukin-4), Immunoglobulin (IgG, IgM, and IgA) and sleep quality index |
Day 1 (Baseline), Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
10/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind,
placebo-controlled study to assess the Immunomodulatory effect and safety of
the Gingeride in adults. The study will also have an open label cross-over
extension. Study will be conducted in male and female participants between the
ages of 18-35 years (inclusive of both the ages). Screening data will be
reviewed to determine participant’s eligibility. Participants who meet all
inclusion criteria and exclusion criteria will be enrolled in the clinical
study.
A total of 24 participants will be enrolled
in the clinical study and randomized into either of the 2 groups in the ratio
of 1:1 (Group A: Gingeride) for 60 days and Group B: Placebo for 30 days
followed by 30 days of administration of standardized Gingeride.
Each enrolled participants will receive their
respective IP, as per the randomisation, from baseline till day 30. On day 30,
(±2 days) (Visit 3), unblinding procedure will be performed. Participants
receiving Gingeride for the first 30 days will continue to receive the same for
the next 30 days while participants receiving the placebo will be receiving
Gingeride for the next 30 days of the study.
The treatment duration is approximately 60 days. |