| CTRI Number |
CTRI/2025/02/080537 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of ear acupuncture in insomnia |
|
Scientific Title of Study
|
Effect of auricular acupuncture at Shenmen and insomnia point on quality of sleep in patients with insomnia: A randomized placebo 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 Ezhiloviam |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9489883348 |
| Fax |
|
| Email |
ezhiloviam@28gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Moovendhan |
| Designation |
Assistant Medical Officer cum Lecturer grade2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ezhiloviam |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9489883348 |
| Fax |
|
| Email |
ezhiloviam@28gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, chennai. |
|
|
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 Ezhiloviam |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Acupuncture and Energy Medicine, Room No 2 Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU |
9489883348
ezhiloviam28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F519||Sleep disorder not due to a substance or known physiological condition, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Auricular acupuncture at Shenmen and Insomnia point |
Auricular acupuncture points are Shenmen and Insomnia point will be inserted bilaterally for 30 minutes a day, 5 days a week for 2 weeks. |
| Comparator Agent |
Placebo acupuncture for 30 minutes a day, 5 days a week for 2 weeks. |
placebo-control group will undergo needling at non-auricular acupuncture points on the Helix of the auricle for 30 minutes a day, 5 days a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as insomnia using Diagnostic and Statistical Manual of Mental Disorders, (DSM –V) criteria.
Willingness and ability to accept needle acupuncture intervention.
|
|
| ExclusionCriteria |
| Details |
Patients with cardiovascular diseases, cerebrovascular diseases & chronic kidney disease.
Patients on sedative drugs like barbiturates and benzodiazepines
Needle phobia
People who are pregnant, lactating and menstruating.
Patients working in shift basis involving frequent and regular changes in day and night work schedule that impacts circadian rhythm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Sleep: Pittsburgh sleep quality index (PSQI) |
Quality of Sleep: Pittsburgh sleep quality index (PSQI) Assessment of quality of sleep will be measured using Pittsburgh sleep quality index (PSQI) before and after 2 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of Insomnia: Insomnia Severity Index (ISI) |
It will be measured using Insomnia Severity Index (ISI) before and after 14 days of intervention. |
| Daytime sleepiness: Epworth Sleepiness Scale (ESS) |
Assessment of daytime sleepiness will be measured using Epworth Sleepiness Scale (ESS) before and after 2 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized placebo-controlled study design will be adopted for this study. All the eligible subjects will be randomly divided into 2 groups. The study group will undergo needling at auricular acupuncture points i.e., Shenmen and Insomnia point for 30 minutes a day, 5 days a week for 2 weeks, whereas, the placebo-control group will undergo needling at non-auricular acupuncture points for 30 minutes a day, 5 days a week for 2 weeks . Assessment of quality of sleep will be measured using Pittsburgh sleep quality index (PSQI).Severity of Insomnia will be measured using Insomnia Severity Index (ISI). Daytime sleepiness will be measured using Epworth Sleepiness Scale (ESS). |