| CTRI Number |
CTRI/2025/02/081308 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| 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
|
A study to compare the effectiveness of Electro-Acupuncture in Oral Sub-Mucous Fibrosis patients |
|
Scientific Title of Study
|
Effectiveness of Electro-Acupuncture as an Alternative Therapy among Oral Sub-Mucous Fibrosis patients- A Randomised 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 S Priyanka |
| Designation |
MDS Student |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College Of Dental Sciences And Hospital |
| Address |
Room no 10, Department of Public Health Dentistry, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9663016941 |
| Fax |
|
| Email |
drpriyankas76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shodan M |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College Of Dental Sciences And Hospital |
| Address |
Department of Public Health Dentistry, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9886811031 |
| Fax |
|
| Email |
shodanm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Priyanka |
| Designation |
MDS Student |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College Of Dental Sciences And Hospital |
| Address |
Room no 10, Department of Public Health Dentistry, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9663016941 |
| Fax |
|
| Email |
drpriyankas76@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka - 580009 |
|
|
Primary Sponsor
|
| Name |
Dr S Priyanka |
| Address |
Room no 18, Shraddha Hostel, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka - 580009 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shodan M |
Department of Public Health Dentistry, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka - 580009 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Priyanka |
SDM College Of Dental Sciences and Hospital |
Dept. of Naturopathy and Yoga, SDM College Of Dental Sciences and Hospital, Sattur, Dharwad, Karnataka - 580009
Dharwad
KARNATAKA |
9663016941
drpriyankas76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College Of Dental Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Conventional management protocol such as cessation of habit, nutritional supplement, antioxidants, topical steroid ointment, and physiotherapy without any intervention for a time period of 1 month.
|
| Intervention |
Electro-acupuncture |
Needle with diameter of 0.25mm will be inserted perpendicularly with the depth of 10mm - 16.7mm approx. at 11 acupoints present in face hands and legs and electrically stimulated with 10-20mA current, the total duration of intervention for each patient will be 240mins or 4hrs which is divided into 8 sessions i.e., 2 sessions weekly with a duration of 30mins each and also provided with conventional treatment such as cessation of habit, nutritional supplement, antioxidants, topical steroid ointment, and physiotherapy without any intervention for a time period of 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Oral sub-mucous fibrosis patients suffer from severe burning sensations, dry mouth, pain, taste disorders, tongue mobility limitations less than 35mm, trismus, dysphagia, and altered tone. |
|
| ExclusionCriteria |
| Details |
A history of bleeding disorder, acupuncture treatment, pregnant or lactating women and subjects with wounds/ tumour in the area of needling.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate pain score 0-10, mouth opening and burning sensation of mouth score 0-10
2) To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment.
|
Every week for 1month and at the end of 2nd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group. |
2months |
| To assess the patient acceptance score 0-10 and satisfaction score 0-10 of electro-acupuncture as an alternate therapy. |
At the end of 1st month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - proposal should be directed to email id [ drpriyankas76@gmail.com ]
- For how long will this data be available start date provided 01-02-2026 and end date provided 31-10-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomised controlled trial comparing the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation among 50 oral sub-mucous fibrosis patients along with conventional treatment in India. The primary outcome measures will be:1. To evaluate the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation of mouth in patients with grade I to grade III oral sub-mucous fibrosis along with conventional treatment. 2. To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment. The secondary outcomes will be: 1. To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group. 2. To assess the patient acceptance and satisfaction of electro-acupuncture as an alternate therapy.
NULL HYPOTHESIS: 1. There is NO difference in pain, mouth opening and burning sensation amongst patients who receive electro-acupuncture therapy along with conventional treatment for Grade I to Grade III Oral Sub-Mucous Fibrosis. 2. Electro-acupuncture therapy along with conventional treatment is NOT effective in comparison with conventional treatment in patients with Grade I to Grade III Oral Sub-Mucous Fibrosis. 3. There is NO significant difference in pain and mouth opening among Grade I, Grade II, and Grade III Oral Sub-Mucous Fibrosis patients between the experimental and control groups. 4. Electro-acupuncture does NOT lead to significant levels of patient acceptance and satisfaction in the treatment of Grade I to Grade III oral sub-mucous fibrosis patients.
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