| CTRI Number |
CTRI/2025/11/096916 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Association between Biological Age and Deha Prakriti
Effect of Amalaki Rasayana on Biological Age in different Prakriti |
|
Scientific Title of Study
|
An Observational Study to Explore the Association between
Biological Age & Deha Prakriti and Clinical Assessment of The
Efficacy Of Amalaki Rasayana on Biological Age in Different
Deha Prakriti Individuals |
| 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 Naina Joshi |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
7983723551 |
| Fax |
|
| Email |
nainajoshi2408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Chhaju Ram Yadav |
| Designation |
Dean PhD and HOD |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Chhaju Ram Yadav |
| Designation |
Dean PhD and HOD |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur Rajasthan 303002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jaipur Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Naina Joshi |
National Institute of Ayurveda |
PG Department of Kriya Sharir
Second floor
Academic Block
National Institute of Ayurveda
Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
7983723551
nainajoshi2408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Rasayana, Reference: Ch.Chi.1-2/8, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy individuals of either sex aged between 18-40 years
Subjects who are willing to participate and sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Known cases of systemic and psychological disorders
Subjects undergoing treatment for any major illness
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase 1
Primary Outcome
Association between Biological Age and Deha Prakriti.
Phase 2
Primary Outcome
Change in Biological Age of subjects after administration of Amalaki Rasayana. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Phase 1
Secondary Outcome
Association between Biological Age and BMR.
Phase 2
Secondary Outcome
Change in Physical parameters and Metabolic markers of subjects after
administration of Amalaki Rasayana. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
15/11/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nainajoshi2408@gmail.com].
- For how long will this data be available start date provided 02-07-2027 and end date provided 02-07-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Understanding the distinction between chronological and biological age allows individuals to take proactive steps towards healthier aging. While chronological age provides a basic framework for understanding how long someone has lived, biological age highlights the variability in how individuals experience aging based on their health behaviours and conditions. By focusing on factors that influence biological age, individuals can potentially improve their overall health and longevity. The concept of Prakriti provides a holistic framework for understanding aging through the lens of individual constitution in Ayurveda. By recognizing how one’s unique characteristics influence health outcomes over time, individuals can adopt personalized strategies for healthy aging. This approach not only addresses physical & physiological health but also considers psychological well-being, leading to a more integrated understanding of the aging process. Emphasizing balance among the dosha through diet, lifestyle choices, and mindfulness can significantly enhance quality of life as one ages. The modern fascination with anti-aging is driven by cultural shifts towards valuing youth, technological advancements in treatment options, scientific discoveries regarding longevity, media influence, and a growing understanding of health risks associated with aging.9 Rasayana plays a vital role in addressing both aging and metabolic function through its holistic approach that combines herbal remedies, dietary practices, and lifestyle modifications. By promoting rejuvenation at cellular levels, enhancing organ function, regulating metabolism, and supporting mental clarity, Rasayana therapies can significantly contribute to healthier aging and improved quality of life. The justification for selecting this trial lies in the integration of Ayurvedic principles with modern scientific inquiry to address aging—a pressing concern in contemporary healthcare. The exploration of Prakriti influence on biological age and the therapeutic potential of Amalaki Rasayana could significantly advance personalized medicine approaches for aging population. Prakriti is a foundational concept in Ayurveda that categorizes individuals based on their physical, physiological and psychological characteristics. Exploring its relationship with biological age can provide insights into personalized healthcare approaches, particularly in aging population. This understanding is critical since aging manifests differently across individuals, influenced by their unique Prakriti. The study design will include a diverse group of participants representing different Deha Prakriti types to ensure comprehensive data on how biological age interacts with individual constitutions. Amalaki Rasayana, derived from the fruit of Phyllanthus emblica, has been traditionally used in Ayurvedic medicine for its rejuvenating properties. Its role in promoting longevity and improving health parameters in aging individuals has been documented, making it suitable for clinical trials aimed at assessing its effects on biological age. Recent studies have indicated that Amalaki Rasayana enhances telomerase activity, which is crucial for maintaining telomere length, an important factor in cellular aging and also highlighted the potential of Amalaki Rasayana to influence other health indicators positively. This necessitates further investigation into its wider impacts on biological aging.14 |