| CTRI Number |
CTRI/2025/09/095190 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to know the Effect of Vidaryadhi Gana Kashaya in memory loss |
|
Scientific Title of Study
|
An label comparative clinical study to evaluate the effect of vidaryadhigana kashaya capsule with and without daiva vyapasrya chikitsa in smritibhramsa w s r to senile dementia |
| 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 Vedantam vinay vardhan |
| Designation |
PG Scholar |
| Affiliation |
SDM college of ayurveda kuthpady udupi. |
| Address |
Department of pg studies in manovijnana evum manasa roga
SDM college of ayurveda kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8867675162 |
| Fax |
|
| Email |
vinaysdm23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shrilatha kamath T |
| Designation |
professor and head of the department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady, Udupi 574118
Udupi
KARNATAKA
574118
India |
| Phone |
9964899638 |
| Fax |
|
| Email |
shri9503@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedantam vinay vardhan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital & Research Centre Kuthpady |
| Address |
Department of pg studies in manovijnana evum manasa roga
Udupi
KARNATAKA
574118
India |
| Phone |
8867675162 |
| Fax |
|
| Email |
vinaysdm23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Vedantam vinay vardhan PG Scholar Department of pg studies in Manovijnana evum Manasa Roga
Sri Dharmasthala Manjunatheshwara college of Ayurveda Hospital and Research centre, kuthpady , Udupi. |
|
|
Primary Sponsor
|
| Name |
Dr Vedantam vinay vardhan |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady, Udupi 574118
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr shrilatha kamath T |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady, Udupi 574118
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vedantam vinay vardhan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
Department Of Pg Studies In Mano Vijnana Evum Mansa Roga
General OPD number 3 And IPD
Sdm College Of Ayurveda, Kuthpady Udupi.
Udupi
KARNATAKA |
8867675162
vinaysdm2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM College of Ayurveda , Kuthpady , Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F039||Unspecified dementia. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: vidaryadhi gana kashaya capsule , Reference: astanga hridaya sutra sthana 15 chapter , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: vidaryadhi gana kashaya capsules of 500 mg each given in the dose of 4 tid
12 capsules per day
before food with warm water | | 2 | Comparator Arm | Procedure | - | daivavyapASraya-cikitsA, दैवव्यपाश्रय-चिकित्सा | (Procedure Reference: charaka samhita sutrasthana 11 chapter, Procedure details: Mantra chikitsa( Audio therapy) with Vedoktha Sloka (buddhir balam yasho dhairyam nirbhayatvam arogatam ajadytam vak patutvam cha hanumat smaranath bhavet) twice in a day,30min before food . Duration of audio 20 seconds chanted for 21 times for 7 minutes after taking bath.)
|
|
|
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling DSM-5 Diagnostic criteria and having the symptoms of Na Smarathi
(no remembrance) or Ayathava Ardha Smarathi (incomplete remembrance of things).
Patients are selected of age group of 60 and above
Patients willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
Patient suffering from other systemic illness and other metabolic disorders interfering with the treatment protocol
Patients suffering from other psychiatric illness or disorders.
Patients suffering from substance abuse |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of capsule Vidaryadhi gana kashaya in senile dementia by improving cognitive function, memory,executive function like decision making. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Concern of individual or a knowledgeable informant complaining there is mild decline in cognitive functions like Executive function, Language, Learning and Memory. Without any behavioral disturbances.
Severity specified i.e mild to moderate |
28 days |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/10/2025 |
| 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="3"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
CONCEPTUAL UNDERSTANDING OF SENILE DEMENTIA - AN AYURVEDIC PERSPECTIVE. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ageing is an inevitable physiological process that ultimately leads to death. It is divided into two types Kalaja and Akalaja 1. As the time progresses from birth to death age related diseases arise. Old age is an incurable disease which sums the image of frail wrinkled skin, dribbling of saliva, uncontrollable bowel and bladder,declined memory, intellect, thought process, change in behaviour without altered consciousness. Dementia is an acquired deterioration in cognitive ability that impairs successful performance of activities of daily living. Memory is the most common cognitive ability lost with dementia. Recent study showed 10% of the individual above age group of 70 and 20- 40% of individual above 85 years have clinically identified memory loss2.It is defined as a global impairment of cognitive function and is progressive and non-reversible. Dementia, after being ruled out by various causes of mental deterioration such as Alzheimer’s, Parkinson’s disease, somatic causes like Cerebrovascular accident, Head trauma, Alcohol induced and Vascular changes. Dementia caused due to old age is explained as Degenerative changes occurring in the brain. Patients lose their abilities to perform day to day activities necessitating assistance from care givers. Despite advancements in the field of medicine, addressing the diseases of old age remains a significant challenge in this century. There are still limitations in curing and treating conditions like Dementia. Hence there is a need for detailed studyin the field for therapeutic aspects of SmritiBhramsha/Senile Dementia. This study is planned to evaluate inducing good / adequate quality of life. |