| CTRI Number |
CTRI/2025/06/088009 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
How Electro-Acupuncture at Four Gate Points Helps Participants in Post-Stroke Rehabilitation Improve Thinking and Memory: A Quasi experimental study |
|
Scientific Title of Study
|
Effect of Electro-acupuncture at Siguan points (Four Gate points) on Cognitive functions of Post Stroke Rehabilitation Patients: A Quasi Experimental Study |
| 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 Ishwariyaa S |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu |
| Address |
International Institute Of Yoga And Naturopathy Medical Sciences Chengalpattu-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9585533255 |
| Fax |
|
| Email |
drishwariyaas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali Shankar |
| Designation |
Head of Department |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam, Tamil Nadu 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat.007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishwariyaa S |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu |
| Address |
International Institute Of Yoga And Naturopathy Medical Sciences Chengalpattu-603001
TAMIL NADU
603001
India |
| Phone |
9585533255 |
| Fax |
|
| Email |
drishwariyaas@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam, Tamil Nadu 603001 |
|
|
Primary Sponsor
|
| Name |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Ammanambakkam Tamil Nadu 603001 |
| 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 Ishwariyaa S |
International Institute Of Yoga And Naturopathy Medical Sciences |
Naturopathy and Yoga Branch 3, Department of Acupuncture and Energy medicine, International Institute Of Yoga And Naturopathy Medical Sciences 184/4, Kamarajar Nagar Chengalpattu, Vallam, Tamil Nadu 603001
Kancheepuram
TAMIL NADU |
9585533255
drishwariyaas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee International Institute of Yoga and Naturopathy medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electro-Acupuncture |
The sterile needles will be inserted at Liv-3 and LI-4 bilaterally and electrical stimulation of 2 -10Hz with continuous frequency will be given through the Nerve and muscle stimulator (Type SDZ-II) for all the points for 20 minutes in lying position, once a day, and thrice a week for 1 month. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants will include adults aged 30 to 60 years who have been diagnosed with ischemic or hemorrhagic stroke confirmed by imaging (CT or MRI), with stroke onset occurring within the past 3 to 12 months. Eligible individuals will have mild to moderate cognitive impairment, as assessed by the Montreal Cognitive Assessment (MoCA), and a stable medical condition without severe complications or comorbidities. Participants must be actively involved in a stroke rehabilitation program, demonstrate sufficient functional mobility to attend study visits and participate in therapy sessions, and must not have received acupuncture treatment within the past month. |
|
| ExclusionCriteria |
| Details |
Patients with severe cardiac, hepatic, renal, or respiratory diseases, as well as those with poorly controlled hypertension or diabetes. Individuals with severe strokes causing significant impairments, severe cognitive impairments, pre-existing dementia, or severe mental health disorders such as schizophrenia, bipolar disorder, or severe depression will also be excluded. Pregnant or lactating women, patients who have experienced another stroke within the last three months, or those currently undergoing conflicting therapies such as other forms of acupuncture, intensive physiotherapy, or cognitive rehabilitation are not eligible. Additionally, patients with pacemakers or other electronic implants, a known allergy to acupuncture needles or materials used in electroacupuncture, or those who have undergone major surgery in the past three months will be excluded. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MoCA test |
Baseline assessment 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Reaction Time and Auditory Reaction Time |
Baseline assessment
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drishwariyaas@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 15-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Stroke is the third leading cause of disability-adjusted life years globally, with about one-fifth of stroke survivors experiencing disabilities three months post-stroke. Cognitive impairments, including mild cognitive impairment (MCI) and dementia, are common post-stroke, with prevalence rates of 37% and 21%, respectively, within 3 to 6 months. The hippocampus, a key region for mood and cognition, is particularly vulnerable to ischemia/reperfusion injury. Acupuncture, a traditional Chinese medicine technique, has shown therapeutic benefits in post-stroke rehabilitation. Specifically, the Siguan acupoints (LI4 and Liv3), widely used for neurological and cognitive disorders, have demonstrated effectiveness in improving cognitive functions. Electro-acupuncture (EA) at Siguan points has been found to exert antidepressant effects comparable to fluoxetine in preclinical studies. This study aims to evaluate the efficacy of EA at Siguan points on cognitive function in post-stroke rehabilitation patients with mild to moderate cognitive impairment within one year of stroke onset. If successful, the findings could support the use of this cost-effective and minimally invasive intervention to prevent the progression of MCI to dementia in stroke survivors.
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