| CTRI Number |
CTRI/2025/03/083189 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on Smriti Vibhramsha(Subjective Cognitive Impairment) with Amalakyadi rasayana and Guduchyadi rasayana |
|
Scientific Title of Study
|
An Etiopathological Study Of Smriti Vibhramsha With Special Reference To Subjective Cognitive Impairment And Comparative Therapeutic Evaluation Of Amalakyadi Rasayana And Guduchyadi Rasayana In Its Management |
| 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 Anusree V V |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no: 152, Department of Roga Nidana Evam Vikriti Vigyana , National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9061675454 |
| Fax |
|
| Email |
anusreevv19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gavali |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Roon No: 149, DepartmentNational Institute of Ayurveda, Madhav vilas palace, Amer road,Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8851832017 |
| Fax |
|
| Email |
preeti.620@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Gavali |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Roon No: 149, DepartmentNational Institute of Ayurveda, Madhav vilas palace, Amer road,Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8851832017 |
| Fax |
|
| Email |
preeti.620@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA, Jorawar Singh Gate, Amer Road,Jaipur- 302002(RAJ.)INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate, Amer Road, Jaipur - 302002(RAJ.)INDIA |
| 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 Anusree V V |
National Institute of Ayurveda |
OPD 17, Department of Roga Nidana Evam Vikriti Vigyana, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN |
9061675454
anusreevv19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smriti vibhramsha |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi rasayana, Reference: YR74/21, BR 73/22, CD 66/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalakyadi rasayana, Reference: YR 74/17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of Smriti vibhramsa and Subjective Cognitive Impairment will be
enrolled after confirmation through Cognitive Assessment Questionnaire and MMSE.
Patients with courses characterized by gradual onset and continuing decline.
Patients with deficits represent a decline from a previous higher level of functioning. |
|
| ExclusionCriteria |
| Details |
Subjects below 40 and above 70 yrs of age.
Subjects with any type of listed psychiatric disorders.
Known case of any neurological disease / Organic brain disease that accounts for the illness.
Known case of Epilepsy/ Schizophrenia/ Uremia
Pregnant women
Lactating mother
Subjects suffering from severe systemic diseases like T.B., cancer etc. will also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Changes in the score of The Cognitive Assessment Questionnaire.
Changes in the score of The Mini Mental State Examination.
|
After 45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the symptoms of the concerned disease.
|
After 45 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/06/2025 |
| 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="0"
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
|
Lifestyle changes and stressful circumstances has altered the psychological equilibrium of man. Hence, mental health promotion and management of various psychological and psychosomatic disorders are necessary. So, it is the need of the era to interpret the ancient concepts of Smriti with respect to modern medical and psychological sciences. SCI has recently attracted renewed attention on the assumption that it could be the first notable manifestation in the preclinical stage of Alzheimer’s disease and dementia. In light of the projected increase of people living with dementia all over the world, there is a strong interest in early risk stages that may allow for early intervention or the prevention of dementia. At present, many modern drugs which are available for various mental disorders are not safe to use because of their serious adverse effects. Ayurveda considers ageing as an inevitable part of life which can be delayed and its ill effects can be minimized by use of specific therapeutic interventions like rasayana. Rasayana has the potential to tackle the problems of neurodegeneration and its effect on cognition, thereby enhancing the quality of life of a person. RESEARCH QUESTION a. What are the etiopathological factors contributing to Smriti vibhramsa with special reference to Subjective Cognitive Impairment in present time? b. Is there any difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smritikshaya with special reference to Subjective Cognitive Impairment? HYPOTHESIS Null Hypothesis [Ho] There is no difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. Alternative Hypothesis [HA] There is difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. AIMS To assess and compare the therapeutic efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. OBJECTIVES Primary objectives To assess the comparative therapeutic efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. Secondary objectives To study the etiopathogenesis of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. To assess the therapeutic efficacy of Amalakyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment. To assess the therapeutic efficacy of Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.
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