| CTRI Number |
CTRI/2024/05/067341 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| 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
|
Immediate Effect of Acupuncture With Moxibustion On Autonomic Function in Healthy Individuals - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Immediate effect of acupuncture and moxibustion to GV8, GV9, GV10, GV11 on autonomic function in healthy individuals- a randomized controlled 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 |
M H VINOTHKUMAR |
| Designation |
PG Scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Acupuncture and Energy medicine,
2nd floor,PG Block,
Government yoga and Naturopathy medical college and hospital,
Arumbakkam, chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9600169700 |
| Fax |
|
| Email |
vkdrsamurai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AMooventhan |
| Designation |
Assistant Medical Officer cum Lecturer G-II, Department of Research |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Research,
2nd floor,PG Block,
Government yoga and naturopathy medical college and hospital,
Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MH VINOTHKUMAR |
| Designation |
PG Scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of Acupuncture and Energy medicine,
2nd floor,PG Block,
Government yoga and Naturopathy medical college and hospital,
arumbakkam, chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9600169700 |
| Fax |
|
| Email |
vkdrsamurai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai-106 |
|
|
Primary Sponsor
|
| Name |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital,
arumbakkam, chennai-106 |
| 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 M H Vinothkumar |
Government yoga and naturopathy medical college and hospital |
Department of Acupuncture and energy medicine,
Second floor, PG Block,
Government yoga and naturopathy medical college and hospital,
Arumbakkam, Chennai
Chennai
TAMIL NADU |
9600169700
vkdrsamurai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital, Chennai Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture and Moxibustion |
The subjects will receive acupuncture needling on GV8, GV9, GV10, and GV11 while sitting position. This will be followed by moxibustion (burning dried mugwort-Artemisia vulgaris) for 15 minutes with 3 minutes on each acupuncture point. |
| Comparator Agent |
Control group |
subject will not receive any kind of intervention and instructed to quite sittings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
subject who are willing to participate in this study |
|
| ExclusionCriteria |
| Details |
Subjects who had systemic disorders (e.g. Cardiovascular system, Respiratory system, Renal system)
Subjects who had Eye related disorders
Subjects diagnosed with any mental illness
Subjects have undergone hospitalization or surgery in the past 6 months
Pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pupillary light reflex will be assessed by using Dynamic Pupillometry |
Baseline will be assessed before intervention and Post assesssment will be taken immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate & Heart rate variability will be assessed before & after the intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel polygraph). |
Heart rate & Heart rate variability will be assessed before & immediately after the intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel polygraph). |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/07/2024 |
| 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 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 - NO
|
|
Brief Summary
|
A randomized control study design will be adopted for this study. 100 participants will be recruited
from Government Yoga and Naturopathy medical college and hospital and randomized into two
groups of 50 namely study and control groups respectively. After baseline assessment of outcome
variables, both groups will undergo their respective interventions, after
which post-assessments will be made. The study group will receive acupuncture and moxibustion at four acupuncture points. The control group will not receive any intervention. The primary outcome variable is Reflex
Latency (RL), Minimum Pupil Diameter (MPD), Baseline Pupil Diameter (BPD),
Maximum Constriction Velocity (MCV), Maximum Redilation
Velocity (MRV), Absolute Constriction Amplitude (ACA), Absolute Dilation
Amplitude (ADA), Duration Of Constriction (DC) And Duration Of Dilation (Dd)
will
be assessed before and after the intervention by using Dynamic
Pupillometry. the secondary outcome variable is Heart rate
and Heart rate variability will be assessed before and after the
intervention by using a 16-channel polygraph (BIOPAC MP160, 16-channel
polygraph). The
values collected at baseline and immediately after intervention will be analyzed. |