| CTRI Number |
CTRI/2024/01/062079 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Immunological and Virucidal effect of Amrita Tablet for Prevention of HIV AIDS |
|
Scientific Title of Study
|
A study to investigate the antiretroviral drug in Ayurveda. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBrajeshwar Mishra |
| Designation |
Director |
| Affiliation |
YCB Ministry of AYUSH |
| Address |
Satyananda yoga and Ayurveda Research institute Motihari (camps of R N M Ayurveda Medical
college and M H K S Hospital Baswariya Pataura Motihari) East Champaran
Purba Champaran
BIHAR
845402
India |
| Phone |
8969127251 |
| Fax |
|
| Email |
dr.brajeshwarmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBrajeshwar Mishra |
| Designation |
Director |
| Affiliation |
YCB Ministry of AYUSH |
| Address |
Satyananda yoga and Ayurveda Research institute Motihari (camps of R N M Ayurveda Medical
college and M H K S Hospital Baswariya Pataura Motihari) East Champaran
BIHAR
845402
India |
| Phone |
8969127251 |
| Fax |
|
| Email |
dr.brajeshwarmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBrajeshwar Mishra |
| Designation |
Director |
| Affiliation |
YCB Ministry of AYUSH |
| Address |
Satyananda yoga and Ayurveda Research institute Motihari (camps of R N M Ayurveda Medical
college and M H K S Hospital Baswariya Pataura Motihari) East Champaran
BIHAR
845402
India |
| Phone |
8969127251 |
| Fax |
|
| Email |
dr.brajeshwarmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grand in aid
By All India Ayurvedic Research and Educational Trust |
|
|
Primary Sponsor
|
| Name |
Satyananda yoga and Ayurveda Research institute Motihari |
| Address |
Campus ofRNM Ayurveda Medical college and MHKS Hospital Baswariya Pataura Motihari East champaran Bihar |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central council for Research Ayurveda sciences CCRAS |
Ministry of AYUSH Government of India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBrajeshwar Mishra |
OPD of Maharaja Harendra Kishor Singh Hospital Motihari |
Campus of R N M Ayurveda Medical college and MHKS Hospital Baswariya Pataura Motihari East Champaran
Purba Champaran
BIHAR |
8969127251
dr.brajeshwarmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R760||Raised antibody titer. Ayurveda Condition: OJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosis to be HIV Positive |
|
| ExclusionCriteria |
| Details |
Taking immunomodulatory
drugs
Patient of antiretroviral Therapy
Pregnancy or lactation
Children |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increasing Ojas immune function to decrease viral load.
|
24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measuring the psychometric properties of WHOQOL HIV Bref to improve the quality of life
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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 1 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| 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="2"
Months="1"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
AIDS is a fetal illness coused by Humam immunodeficiency Virus HIV which breaks down the host immune system. This is responsible for the progressive immune system damage in Infected person. In Ayurveda AMRITA Tablet is an ideal herbal formulations of the mainly Rasayana drugs.Rasayana drug enhancing immunity for optimal level of Rasrakadi dhatu.It promotes strenght Vitality longevity and improve mental faculties. In this perspective there are two main two objectives can be study the immunological and virudical effect of Amrita Tablet on HIV positive patients. First assess the Amrita Tablet for restoration of Immunological function and suppression of viral load and second to evaluate the effect of AMRITA Tablet on the psychometric properties of WHOQOL HIV -Bref in infected adults. |