| CTRI Number |
CTRI/2021/08/035738 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Kutki as an
immune booster in adult and elderly population. |
|
Scientific Title of Study
|
A Randomized, Placebo controlled, double blinded, parallel group
clinical study to evaluate the efficacy and safety of IAI01 (Kutki) as an
immunomodulator in adult and elderly population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principle Investigator/ Consultant |
| Affiliation |
PM Medical Centre & KI3, CRO |
| Address |
Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu. Vellore TAMIL NADU 632401 India
Vellore
TAMIL NADU
632513
India
Vellore
TAMIL NADU
632513
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principle Investigator/ Consultant |
| Affiliation |
PM Medical Centre & KI3, CRO |
| Address |
Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu. Vellore TAMIL NADU 632401 India
Vellore
TAMIL NADU
632513
India
Vellore
TAMIL NADU
632513
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principle Investigator/ Consultant |
| Affiliation |
PM Medical Centre & KI3, CRO |
| Address |
Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu. Vellore TAMIL NADU 632401 India
Vellore
TAMIL NADU
632513
India
Vellore
TAMIL NADU
632513
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| InnAdapt Immune Door No: 7-124/4/D, Road No 15, Vinayaknagar, Jeedimetla IDA,
Phase-1, Hyderabad-500055, India, |
|
|
Primary Sponsor
|
| Name |
InnAdapt Immune |
| Address |
Door No: 7-124/4/D, Road No 15, Vinayaknagar, Jeedimetla IDA,
Phase-1, Hyderabad-500055, India, |
| 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 Ramesh Kannan |
PM Medical Centre |
Room no:10, Dept. of Medicine, OPD, Wallajapet, Ranipet, Tamil Nadu. Vellore
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ki3 |
Approved |
| PM Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Efficacy of the drug in improving the immunity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kutki, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: kutki, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to provide written informed consent prior to performing study procedures.
2. Adult patients aged more than 45 years with or without co morbidities like hypertension and Diabetes mellitus, who are on regular treatment.
|
|
| ExclusionCriteria |
| Details |
1. Participants with any active illness or infections including COVID19.
2. Patient having HIV infection.
3. Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
4. Have had cancer.
5. Have received any of the following within 3 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR< 30)
8. Immuno-compromised patients on medications.
9. Patients who are on medication of immuno supressors/steroids/antibody (mAb etc), whether injectables/oral/topical, for their other health condition
10. Participation in any other clinical trial of an experimental treatment in the past 3 months.
11. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of absolute, naïve, effector and memory cell counts of B and T-Cells [ Time Frame: Baseline and Day 30]
2. Change from baseline in the following lab parameters namely,
CBC, ESR, RBS, HbA1c, CRP, LFT, RFT, Lipid profile and Serum electrolytes. [Time frame: Baseline, Day 15 (Except HbA1c) and Day 30]
3. Change from baseline in IL-2, IL-4, IL-10 and P53 levels [Time frame: Baseline and Day 30]
|
DAY 1, DAY 15, DAY 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire.
2. Number of sick days
3. Incidence and Duration (days) of hospitalization if any.
[ Time Frame: through Day 30 ]
|
DAY 1, DAY 15, DAY 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2021 |
| Date of Study Completion (India) |
25/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The selected 60 participants will be randomized into 2 groups with 30 in each group. 1) Test Group -Participants without any active illness Out of 30 participants, 10 will be in the age group of 45-54 years, 10 will be in the age group of 55-64 years and 10 will be in the age group of 65-75 years.
2) Placebo Group- Age and sex-matched participants like that of test group without any active illness. All key co-interventions will be documented.
The primary outcome: Assessment of absolute, naive, effector and memory cell counts of B and T-cells (time frame BAseline day,30) Change from baseline in the following lab parameters namely, CBC, ESR,RBS, HbA1c, CRP, LFT<RFT, Lipid profile and Serum electrolytes(Tiem Frame, BAseline, Day 15 (except HbA1c, day 30) Change from baseline in IL-2, IL-4, IL-10 and P53 levels (Time BAseline and Day 30)
Secondary Outcome
To monitor for any adverse events during the study period and assess the quality of life using a pre-and-post feedback questionnaire Number of sick days Incidence and Duration (days ) of hospitalization if any(Time frame: through Day 30)
The results of the placebo and treatments arm will be analaysed and compared
|