| CTRI Number |
CTRI/2026/03/105095 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the Ayurvedic Rasayana effect in improvement of memory |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Vriddha Darak Rasayana in the Enhancement of Smriti wsr to Amnestic Mild Cognitive Impairment (aMCI) |
| 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 Viveka |
| Designation |
MD Scholar |
| Affiliation |
KSVAMC RC Gangoh UP |
| Address |
Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8397069707 |
| Fax |
|
| Email |
deswalviveka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagufta Malhotra |
| Designation |
Associate Professor |
| Affiliation |
KSVAMC RC Gangoh UP |
| Address |
Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9988646655 |
| Fax |
|
| Email |
shagufta.malhotra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viveka |
| Designation |
MD Scholar |
| Affiliation |
KSVAMC RC Gangoh UP |
| Address |
Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8397069707 |
| Fax |
|
| Email |
deswalviveka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurveda Medical College and Research Centre |
| Address |
OPD NO 1 Department of PG studies in Kaya Chikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur 247341 UP |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Viveka |
Kunwar Shekhar Ayurved Medical College and Research Centre Gangoh Saharanpur 247341 |
Department of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research centre Gangoh Saharanpur 247341
Saharanpur
UTTAR PRADESH |
08397069707
deswalviveka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F04||Amnestic disorder due to known physiological condition. Ayurveda Condition: other, (2) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vriddhadarak Rasayana, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ghrit), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i Participants in this study will be community dwelling persons aged 35 to 60 years diagnosed persons with amnestic mild cognitive impairment using Petersons amnestic MCI Criteria ie
1 Memory Complaint Subjective response to standardized question
2 Norrmal general Cognitive function Mini Mental State Examination score more than 25 MoCA 18 to 25
3 Intact activities of daily living ADCS ADL MCI more than 51
4 No Dementia Clinical Dementia rating score less than 1
5 Impaired memory objective evidence for age and education Word List Delayed Recall score less than 1 SD below mean memory scale
ii Consented individuals will be irrespective of sex caste religion and race with MCI able to write read and understand the hindi english language will be considered for the study |
|
| ExclusionCriteria |
| Details |
1 Dementia or significant cognitive impairment that interfere with daily life
2 Subjects with Alcohol use Disorders Identification Test AUDIT score more than 3
3 Pregnant women
4 Lactating mother
5 Any Systemic disorders like kidney disorders liver disorders and cardiac disorders
6 Neurological conditions like Parkinsons disease multiple sclerosis or stroke that can affect cognition
7 Psychiatric conditions like depression Schizophrenia and anxiety
8 Participants taking medications that can affect cognitive function such as sedatives and anticholinergics
9 Subjects with uncontrolled blood pressure diabetes mellitus or hypothyroidism
10 Subjects who have received treatment with any approved or investigational health supplements for improvement of cognition and memory within the past one month preceding the screening visit
11 Subjects with abnormal laboratory tests findings such as AST and ALT greater than 3 times the upper limit of normal Hb less than or equal to 8 Platelets count less than 1 lakh
12 Subjects participating in another clinical trial within the 3 months preceding the screening
13 Subjects with a history of traumatic brain injury with loss of consciousness or convulsions
14 MMSE less than 25
15 Subjects with Manda Agni |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Smriti in aMCI |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/04/2026 |
| 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 Yet Recruiting |
| 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
|
To enhance cognitive function Ayurveda recommends rasayana therapy which includes medicinal herbs dietary modifications and lifestyle interventions that rejuvinate the nervous system enhance neuroplasticity and improve cognitive abilities . Vriddhadarak Rasayana a classical memory enhancing rasayana formulation is mentioned in ayurvedic text for enhancing cognition preventing neurodegeneration and restoring memory functions. It contains neuroprotective adaptogenic and anti inflammatory herbs that have been traditionally used to improve mental clarity concentration and memory retention . This study aims to evaluate the clinical efficacy of Vriddhadarak Rasayana in enhancement of Smriti wsr to Amnestic Mild Cognitive Impairment. |