| CTRI Number |
CTRI/2025/04/084614 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To find out the deficit factor in apparently healthy individuals which contributes in Immunity and whose deficiency leads to reduced health outcome. |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE CORRELATION BETWEEN BALA VRIDDHIKAR BHAVA & IMMUNITY, WITH A CLINICAL EVALUATION OF THE IMPACT OF YUKTIKRUTA BALA ON IMMUNE MODULATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no.720, 7th floor, Academic Block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
South
DELHI
110076
India |
| Phone |
7065786146 |
| Fax |
|
| Email |
sheetal07101995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mahesh Vyas |
| Designation |
HOD and Professor of Dept. of Samhita and Siddhant |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no.716, 7th floor, Academic Block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
South
DELHI
110076
India |
| Phone |
8849802005 |
| Fax |
|
| Email |
drmaheshkvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no.720, 7th floor, Academic Block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076
South
DELHI
110076
India |
| Phone |
7065786146 |
| Fax |
|
| Email |
sheetal07101995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi - 110076 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheetal |
All India Institute of Ayurveda |
Room No.7 and 720, Dept. of Samhita and Siddhant
New Delhi
DELHI |
7065786146
sheetal07101995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Ayurveda, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
•Apparently healthy subjects of Survey study with two or more than two aberrant investigation test
|
| Patients |
(1) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: OJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasayana Churna, Reference: Ashtang Hridaya Uttarsthana 39/159, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy subjects of either gender in the age group of 18 – 45 years, irrespective of their caste, religion, socio-economic status etc. will be included
Prior informed written consent will be taken
Apparently healthy subjects of Survey study with two or more than two aberrant investigation test results will be included for Clinical study.
|
|
| ExclusionCriteria |
| Details |
Apparently healthy subjects who are not willing to take part in the study.
Pregnant and lactating females
Subject taking any kind of medication for previous illness in past 12 months.
History of any systemic diseases, hereditary diseases, autoimmune disease and other co-morbidities.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of association between Bala Vriddhikara Bhava and Immunity in apparently healthy individual.(Phase II) |
At the end of Phase II |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correction of the aberrant Immunity biomarkers (CBC with ESR, DLC, CRP and Sr. Immunoglobulin) of apparently healthy individuals.(Phase III)
|
At the end of Phase III |
|
|
Target Sample Size
|
Total Sample Size="371"
Sample Size from India="371"
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)
|
15/05/2025 |
| 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="2"
Months="1"
Days="15" |
|
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 study will be carried out in 3 phase. In Phase I Bala Vriddhikar Bhava Quetionnaire ill be prepared and validated. Phase II of study aims to scientifically and clinically explore the relationship between Bala Vriddhikara Bhava and immunity, using tools such as Bala Vriddhikara Bhava questionnaire and Immune Status Questionnaire, complete blood count (CBC) with ESR, differential leukocyte count (DLC), C-reactive protein (CRP), and serum immunoglobulins. By assessing the "bala" of apparently healthy individuals through these biomarkers, we seek to identify which types of bala—Sahaj, Kalaj, or Yuktikruta—are lacking. This understanding will help inform strategies for disease prevention by enhancing the specific deficit factor, ultimately leading to improved health outcomes. In Phase III the apparently healthy subjects of survey study with two or more than two aberrant investigation test results will be recruited in Clinical study based on the inclusion criteria and will be given Rasayana Churna along with Madhu 06 gram daily once for 60 days which aims to provide evidence that an individual’s "Bala" can be objectively enhanced through current biomarkers. Additionally, the study seeks to improve the Yuktikruta Bala of individuals, contributing to better health result. |