| CTRI Number |
CTRI/2024/02/062707 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| 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
|
Effect of acupuncture needling with the help of current stimulation on stomach movements on gastric trouble patients using stomach 25,36 and urinary bladder 21 acupuncture points |
|
Scientific Title of Study
|
EFFECT OF ELECTRO ACUPUNCTURE ON GASTRIC MOTILITY IN DYSPEPSIA PATIENTS USING ST 25,36 AND UB 21 |
| 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 P Keerthana |
| 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-600 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
6369931695 |
| Fax |
|
| Email |
prakeerthu1009@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 |
| Address |
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block,
Arumbakkam, Chennai-600 106.
Chennai
TAMIL NADU
600 106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Keerthana |
| 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-600 106.
Chennai
TAMIL NADU
600 106
India |
| Phone |
6369931695 |
| Fax |
|
| Email |
prakeerthu1009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam, Chennai-600 106. |
| 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 P Keerthana |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Acupuncture and Energy Medicine, Second floor,PG block,
Arumbakkam, Chennai-600 106.
Chennai
TAMIL NADU |
6369931695
prakeerthu1009@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 |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electroacupuncture |
The study group will receive the electroacupuncture on stomach 25, 36 and Urinary Bladder 21 acupuncture points in a comfortable sitting position with the frequency of 100 Hz and 0.75 mA for about 20 minutes for the total intervention period of about 10 days daily |
| Comparator Agent |
No intervention |
The control group will not receive any acupuncture treatment for the total intervention period about 10 days daily |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with dyspepsia having symptoms for atleast one month without medication.
|
|
| ExclusionCriteria |
| Details |
Patients with psychiatric illness, epilepsy, hypersensitivity, metalic implantation.
Patients under medication for any other systemic illness
Pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Domain frequency
Domain power
Power ratio |
Domain frequency,Domain power,Power ratio will be measured using electrogastrogram on day 1 and day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dyspepsia symptom sum score and Quality of life index |
Dyspepsia symptom sum score and Quality of life index questionnaire will be measured on day 1 and day 10 |
|
|
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)
|
24/03/2024 |
| 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="3"
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
|
It is a Randomized Controlled Trial, consists of 60 population, with the condition of dyspepsia, in which 30 people (study group) will receive an electroacupuncture treatment (Acupuncture needling with electrical stimulation) on stomach 25,36 and urinary bladder 21 acupuncture points with a frequency of 100Hz and 0.75mA for about 20 minutes for 10 days. They will undergo for an electrogastrogram assessment (A technique to measure the electrical activity of stomach) on day 1 before the intervention and day 10 after the intervention. The other 30 people (control group) will not receive any acupuncture treatment. The pre and post assessment will be taken on day 1 and day 10. |