| CTRI Number |
CTRI/2025/12/099848 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Acupuncture treatment for improving cognitive function among postmenopausal women |
|
Scientific Title of Study
|
Effect Of Acupuncture Points (K3,GV16,GB34) On Improving Cognitive Function Among Postmenopausal Women -A Randomized Controlled Trial |
| 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 Fahumidha sinaz S |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine Faculty block International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam TN-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7708735541 |
| Fax |
|
| Email |
sinaz1107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali S |
| Designation |
Head Of Department (i/c) |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine Faculty block International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam TN-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geethanjali S |
| Designation |
Head Of Department (i/c) |
| Affiliation |
International Institute Of Yoga And Naturopathy Medical Sciences |
| Address |
Department of Acupuncture and Energy Medicine Faculty block International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam TN-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical sciences |
|
|
Primary Sponsor
|
| Name |
Dr Fahumidha sinaz S |
| Address |
Department of Acupuncture and Energy Medicine Faculty block International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam TN-603001 |
| 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 Fahumidha sinaz S |
International Institute Of Yoga And Naturopathy Medical Sciences |
Department of Acupuncture and Energy Medicine International Institute Of Yoga And Naturopathy Medical Sciences 184/4 Kamarajar Nagar Chengalpattu Vallam
Kancheepuram
TAMIL NADU |
7708735541
sinaz1107@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture |
The sterile copper needles (tx pinpai single use) will be inserted at K3 Obliquely 0.3–1
cun, In the depression between the highest prominence of the medial malleolus and the Achilles
tendon, GV16 0.5–1 cun slightly obliquely in an inferior direction. Bend the patient’s head
slightly forward when needling, GB34 (B/L) 1–1.5 cun vertical insertion between the tibia and
fibula towards the interosseous membrane using sterile Acupuncture needles 0.5 cun obliquely
and 1 cun vertically, to the skin from the outer to inner parts in the sitting position and retained
for 20 minutes. This intervention will be administered 12 times over a month, with sessions
occurring three times weekly. |
| Comparator Agent |
Waitlist |
In the control group participants will receive no specific intervention and will simply rest in sitting
position This group will serve as a baseline, allowing for the assessment of natural cognitive
changes overtime, without the influence of any external practices or techniques. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women aged 45–60 years defined as having at least 12 consecutive months of amenorrhea not attributable to surgery or medication will be eligible for inclusion Participants must have a Mini-Mental State Examination (MMSE) score between 24 and 27 demonstrate the ability to provide informed consent and be willing to comply with all study procedures Additionally they should have a stable medical condition with no history of acute illness within the past two months |
|
| ExclusionCriteria |
| Details |
Individuals will be excluded if they have a diagnosis of dementia or a major neurocognitive disorder including conditions such as stroke epilepsy schizophrenia Parkinson’s disease or if their MMSE score is below 24 Additional exclusion criteria include the use of cognitive-enhancing medications or hormone replacement therapy within the past six months as well as the presence of chronic uncontrolled hypertension or diabetes or significant cardiovascular hepatic or renal disease Participants with visual or hearing impairments that could interfere with cognitive testing will also be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Critical Flicker Frequency(CFFF) |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Six Letter Cancellation Task (SLCT) involves identifying and cancelling six specified target letters within a worksheet containing randomly arranged letters. Participants are given 1.30 minutes to cancel as many target letters as possible using any preferred strategy or scanning pattern. The task assesses various cognitive functions: total cancellations reflect motor and cognitive efficiency, net score indicates sustained attention, and wrong cancellations reflect poor focus or distraction. After standardized instructions, participants complete the task using pencil and paper, and the sheets are collected immediately. Each cancelled letter is scored as 1, and the net score is calculated by subtracting wrong cancellations from total cancellations. Scoring is performed by an assessor blinded to the study design |
1 Month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2026 |
| 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="11"
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 - 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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [sinaz1107@gmail.com].
- For how long will this data be available start date provided 20-10-2027 and end date provided 20-10-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial examines whether acupuncture at three specific points—K3, GV16, and GB34—can improve cognitive function in postmenopausal women. Seventy participants will be randomly assigned to either an intervention group receiving acupuncture three times per week for four weeks or a control group sitting at rest for the same duration. Cognitive performance will be evaluated before and after treatment using Critical Flicker Fusion Frequency (primary outcome), Six Letter Cancellation Test, and the Women’s Health Questionnaire (secondary outcomes). The study is based on evidence linking menopause-related “brain fog” to hormonal decline, neuroinflammation, autonomic imbalance, and reduced neural connectivity, while acupuncture is proposed to enhance neurotransmission, regulate brain activity, and support mind–body balance according to Traditional Chinese Medicine. Ethical approval, informed consent, and confidentiality procedures will be followed, and statistical analysis will determine whether acupuncture provides measurable cognitive benefits compared to no intervention. |