| CTRI Number |
CTRI/2024/08/072915 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Evaluation of Antioxidant and Immune stimulant Herbal Capsule |
|
Scientific Title of Study
|
Clinical Trial of Herbal Antioxidant and immune stimulant herbal capsule |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof PC Chaudhary |
| Designation |
Principal Investigator and Head of department |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan, State ayurvedic college and hospital, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415864985 |
| Fax |
|
| Email |
drpc.chaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Lecturer |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan, State Ayurvedic College and Hospital, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
06395683971 |
| Fax |
|
| Email |
shailendra.rawat01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Lecturer |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Rog Nidan, State Ayurvedic College and Hospital, Lucknow
UTTAR PRADESH
226003
India |
| Phone |
06395683971 |
| Fax |
|
| Email |
shailendra.rawat01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Defense Institute of Bio Energy Research, A unit of Under Defense ministry, Government of India, Pin code 263139 |
|
|
Primary Sponsor
|
| Name |
Defense institute of Bio Energy Research, A Unit of Under defense ministry Government of India |
| Address |
Diber A unit of DRDO, Pithoragarh Uttarakhand, Pin code 262540 |
| Type of Sponsor |
Research institution |
|
|
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 PC Chaudhary |
State Ayurvedic College and Hospital |
Department of Rog Nidan, State ayurvedic college and hospital, Lucknow Pin code 226003
Lucknow
UTTAR PRADESH |
09415864985
drpc.chaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: OJOVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbal Antioxidant and immune stimulant herbal capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 650(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -Mandukparni (162.50 mg), Ghingaroo (162.50 mg), Brahmi (162.50 mg), Konch (162.50 mg) |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Immunocompromised patients
2. Chronic disease like Diabetes mellitus, Bronchial Asthma, Tuberculosis etc. |
|
| ExclusionCriteria |
| Details |
1. Patients are unstable and severely ill.
2. Patients below age 30 years and above 70 years. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The medicine is expected to improve immunity. Assess by physical parameters according to proforma and pathological parameters i.e. CBC, all IG, LFT, KFT etc. |
Before trial and 60th day of trial and after 30 days of complete trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pathological evaluation and if any side effects |
Before trial and after two months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The clinical trial of herbal product antioxidants and immune-stimulant herbal capsule. Plant ingredients used in the product formulation - Mandukparni (162.50 mg), Ghingaroo (162.50 mg), Brahmi (162.50 mg), Konch (162.50 mg). Each capsule contains dried extract of above drugs, wt of single immunoboost capsule is 650 mg. Earlier preclinical trial of these products has been validated from recognized institute viz CDRI, Lucknow. these products were found toxicologically safe and free from heavy metals. Pharmacological testing i.e. Evaluation of immunostimulant properties of this formulation has been undertaken from department of pharmacology, college of veterinary science, G.B. Pant University of Agri and tech. Pant Nagar. |