| CTRI Number |
CTRI/2024/05/067587 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Determining the effect of duration of ear acupuncture at a specific point |
|
Scientific Title of Study
|
Clinical evaluation of the time effect relationship of auriculoacupuncture at point zero on autonomic function among healthy volunteers |
| 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 D Annamalai |
| Designation |
PG Scholar |
| Affiliation |
International Institute Of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block ,Ground floor , Kamarajar nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9025899710 |
| Fax |
|
| Email |
annamalai.sd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Prabu |
| Designation |
Assistant Medical Officer / Lecturer Grade II |
| Affiliation |
International Institute Of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block ,Ground floor , Kamarajar nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Prabu |
| Designation |
Assistant Medical Officer / Lecturer Grade II |
| Affiliation |
International Institute Of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block ,Ground floor , Kamarajar nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr D Annamalai |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block ,Ground floor , Kamarajar nagar, Chengalpattu |
| 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 D Annamalai |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block ,Ground floor , Kamarajar nagar, Chengalpattu
Kancheepuram
TAMIL NADU |
9025899710
annamalai.sd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Autonomic function |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AURICULO ACUPUNCTURE |
A sterile press needle will be inserted bilaterally at point zero ( root of the helix ) with penetration upto 0.3 mm perpendicularly which is retained for 30 minutes |
| Intervention |
AURICULO ACUPUNCTURE |
A sterile press needle will be inserted bilaterally at point zero ( root of the helix ) with penetration upto 0.3 mm perpendicularly which is retained for 5 minutes |
| Intervention |
AURICULO ACUPUNCTURE |
A sterile press needle will be inserted bilaterally at point zero ( root of the helix ) with penetration upto 0.3 mm perpendicularly which is retained for 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers with BMI less than 25 kg/m2 and who are willing to participate |
|
| ExclusionCriteria |
| Details |
Individuals with open wound in the ear, extensive ear rings, previously diagnosed of psychiatric disease , presence of neurological and cardiac disease, individual under addictions of alcohol , drugs and smoking |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will determine the effectiveness of acupuncture in eliciting parasympathetic activation based on changes in heart rate variability. |
ONLY BASELINE AND 5 MINUTES/30 MINUTES/60 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mini-Wright’s Peak expiratory flowmeter has been used a standard method for Peak expiratory
flow rate will be determined before and after the study and record the changes. |
ONLY BASELINE AND 5 MINUTES/30 MINUTES/60 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
02/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - online
- For how long will this data be available start date provided 10-05-2024 and end date provided 11-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Auriculotherapy (Part of Acupuncture) has been utilized in Traditional Chinese Medicine (TCM)
for both diagnosis and treatment. According to TCM, the ear is believed to be directly connected
with the 12 meridians.Dr. Paul Nogier introduced an ear
diagrammatic chart in 1957, representing an inverted fetus, which was subsequently approved by
the World Health Organization (WHO).In 2009, Dr.Romoli and Mazzoni updated this chart
into a sectogram, incorporating auriculotherapy points that extend outward from the root of the
helix, known as Point Zero. The practice of acupuncture depends on several factors like type of needle, frequency, technique,
manual acupuncture, electrical acupuncture, disease and particularly duration of needle retention
makes it difficult for clinical practice. The duration of
acupuncture treatment has not been paid attention on clinical research so this study focuses on investigating the effects of needle
retention period on auriculotherapy at Point Zero. Healthy volunteers of age group between 18- 40 years with BMI (18-25 kg/m2). After screening of healthy volunteers ,they will be divided into 3 different groups, each group will have n=30
subjects called Arm 1, Arm 2, Arm 3. Participants of Arm 1(n=30) will receive acupuncture at
Point zero with Press needle(3×3mm) for a duration of 5 minutes, Arm 2(n=30) participants will
receive the same procedure for 30 minutes and participants of Arm 3 will receive the same
procedure for 60(n=30) minutes. As a primary outcome, HRV will be assessed on baseline and after 5/30/60 minutes. As a secondary outcome, PEFM ( Peak Exploratory Flow Meter) will be assessed on baseline and after 5/30/60 minutes. |