| CTRI Number |
CTRI/2025/10/096681 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| 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 acupuncture at Heart 7, Pericardium 6 and ear acupuncture points on sleep quality among individuals with insomnia |
|
Scientific Title of Study
|
Effect of needling at acupuncture points (H7 and P6) and auricular points (Shenmen and Point Zero) on sleep quality in patients with insomnia: 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 M Sandhiya |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Government Yoga and Naturopathy Medical College and Hospital
Department of Acupuncture and Energy medicine, Second floor, PG block, Arumbakkam, chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
6383313266 |
| Fax |
|
| Email |
msandhiyadpi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Government Yoga and Naturopathy Medical College and Hospital
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 A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Government Yoga and Naturopathy Medical College and Hospital
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 |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical college and hospital, Arignar Anna Indian Medicine Campus, 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, Tamil Nadu, India |
| 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 Sandhiya |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
Government Yoga and Naturopathy Medical College and Hospital
Department of Acupuncture and Energy medicine, Second floor, PG block, Arumbakkam, chennai
Chennai
TAMIL NADU |
06383313266
msandhiyadpi@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 Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture needling at Heart 7, Pericardium 6 with auricular needling at shenmen, zero point |
Acupuncture and auricular points will be located. After that, acupuncture needles will be inserted bilaterally for a duration of 20 minutes. The treatment will be provided 10 sessions for 2 weeks
|
| Comparator Agent |
placebo Acupuncture and auricular needling for 20 minutes, 10 sessions for about 2 weeks |
Acupuncture needling on non- acupuncture points (1 cun lateral to H7 and P6) and non - auricular points on the helix for about 20 minutes, 10 sessions for 2 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Insomnia Severity Index (ISI) score should be greater than 14
Willing to participate in the study
Patients diagnosed with insomnia by using Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
|
|
| ExclusionCriteria |
| Details |
Female participants who are pregnant or currently breastfeeding
Individuals engaged in night shift work schedules
Participants diagnosed with sleep apnea, narcolepsy, restless legs syndrome, or any chronic painful condition
Regular Use of caffeine exceeding 600 mg per day
History of alcohol or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index
(PSQI) |
Pittsburgh Sleep Quality Index (PSQI) questionnaire will be taken before and after 10 days of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insomnia Severity Index (ISI) |
Insomnia Severity Index (ISI) questionnaire will be taken before & after 10 days of the 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)
|
25/12/2025 |
| 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 Yet Recruiting |
| 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 controlled study design
will be adopted in this study. All the eligible subjects will be randomly
divided into 2 groups. Participants in the study group will receive a
combination of needling at acupuncture points (H7 and P6) and auricular points
(Shenmen and Point Zero), while the control group will undergo sham
acupuncture, which involves superficial needling at non-acupuncture points on
the body and shallow insertion in non-auricular sites for about for 20 minutes
per session, 10 days for 2 weeks. Assessments will be performed before and
after a two-week intervention. |