| CTRI Number |
CTRI/2025/03/082105 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Vruddhadaraka Rasayana (a medicated polyherbal preparation in the form of powder)on Smriti(memory). |
|
Scientific Title of Study
|
An Interventional Study To Evaluate The Efficacy Of Vruddhadaraka Rasayana on Smriti(Memory) |
| 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 Laxmi Ravindra Benakannavar |
| Designation |
P G Scholar |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7259021174 |
| Fax |
|
| Email |
laxmibenakannavar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GAYATRI HOLLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8277402214 |
| Fax |
|
| Email |
hollagayathri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Ravindra Benakannavar |
| Designation |
P G Scholar |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidre, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
Karnataka
574227
India
Belgaum
KARNATAKA
574227
India |
| Phone |
7259021174 |
| Fax |
|
| Email |
laxmibenakannavar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PG studies in Kriya Shareera Alvas Ayurveda Medical college and Hospital Vidyagiri, Moodubidre,Dakshina Kannada Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Laxmi Ravindra Benakannavar |
| Address |
Department of PG STUDIES in Kriya Shareera Alvas Ayurveda Medical and Hospital Vidyagiri Moodubidre Dakshina Kannada Karnataka 574227 India |
| Type of Sponsor |
Other [(SELF)] |
|
|
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 Laxmi Ravindra Benakannavar |
Alvas Ayurveda Medical College |
4th floor Department of PG Studies in Kriya Shareera of Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidre Dakshina Kannada Karnataka 574227
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
7259021174
laxmibenakannavar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Alvas Ayurveda Medical college Vidyagiri Moodubidre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subject With Memory Scores Between 20 to 60 In PGI Memory Scale |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | - | | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VRUDDHADARAKA RASAYANA , Reference: CHAKRADATTA 66th chapter , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -GHRITA ), Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Student of age group 18 to 25 years irrespective of gender religion marital status and socio-economic status. Subject with memory score between 20 to 60 in PGI Memory Scale. |
|
| ExclusionCriteria |
| Details |
Individual Who Are Having Any Psychiatric Disorder
Individual Who Are Having Any Cognitive Disorder
Pregnant and Lactating Women
Individual Who Are Illiterate
Individual Who Are On Regular Medication
Any other conditions Which Directly or Indirectly Interferes this study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase In Memory To Evaluate The Efficacy Of Vruddhadaraka Rasayana on Smriti(Memory) |
60 days treatment follow up period 31th day 62th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="0"
Months="2"
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
|
It is clinical study to evaluate the Vruddhadaraka Rasayana in the form of Churna on Smriti that is Memory.medicine will be given for 60days total 65th days of follow up.Total 30 subjects That will be Conducted in the department of kriya sharir Alvas Ayurveda Medical college Vidyagiri Moodubidre |