| CTRI Number |
CTRI/2024/02/062277 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of melatonin prophylaxis on the post-operative pain and sensory recovery following lower jaw fractures. |
|
Scientific Title of Study
|
Effectiveness of melatonin prophylaxis on the post-operative pain and sensory recovery following mandibular fractures - A Randomized controlled clinical trail |
| 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 Sai Shruthi |
| Designation |
POST GRADUATE |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No 420 Fourth Floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605103
India |
| Phone |
9487458315 |
| Fax |
|
| Email |
shruthi.sai46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Sai Shruthi |
| Designation |
POST GRADUATE |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No 420 Fourth Floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605103
India |
| Phone |
9487458315 |
| Fax |
|
| Email |
shruthi.sai46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Sai Shruthi |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
Room No 420 Fourth Floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605103
India |
| Phone |
9487458315 |
| Fax |
|
| Email |
shruthi.sai46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Dental College Ariyur Puducherry |
|
|
Primary Sponsor
|
| Name |
Dr M Sai Shruthi |
| Address |
Room No 420 Fourth floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur |
| Type of Sponsor |
Other [Self ] |
|
|
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 Yuvaraj V |
Sri Venkateshwaraa Dental College |
Room No 420 Fourth floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY |
9655810326
omfssvdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T758||Other specified effects of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Melatonin 10 mg |
Given pre operatively on the day before surgery and post operative day 0 to day 21 once daily |
| Comparator Agent |
Capsule Placebo |
Given pre operatively on the day before surgery and post operative day 0 to day 21 once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient fit for surgical procedure under general anesthesia
2 Patient reporting to the department OPD with mandibular fractures
3 Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Pregnancy and breast feeding
2 Hepatic dosing
3 Renal dosing
4 Auto Immune condition
5 Patient consuming anti platelet drugs
6 Patient consuming anti coagulant drugs
7 Patient consuming anti convulsant drugs
8 Patient consuming anti epileptic, CNS depressants drugs
9 Patients consuming oral contraceptives
10 Patient not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensory recovery
|
Post operative day 7,30 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post surgical pain & numbness |
Post surgical pain - Post operative Day 1,3 & 7
numbness - Post operative day 7,30 AND 90 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 4 |
|
Date of First Enrollment (India)
|
09/02/2024 |
| 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="5"
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
|
Title of the study is Effectiveness of melatonin prophylaxis on post-operative pain and sensory recovery following mandibular fractures- a randomised controlled clinical trial. Aim of the study is to evaluate the effectiveness of melatonin prophylaxis on sensory recovery and post operative pain following surgery after mandibular fractures. The primary objective is to evaluate the efficacy of melatonin prophylaxis on sensory recovery. The secondary objective is to assess the efficacy of melatonin in reducing post surgical pain and numbness. the sample of the study is 24. 12 samples will be taken for each group, so a total of 24 samples will be taken and divided into two groups: study group and control group. The inclusion criteria is patients between 18 to 55 years coming to the hospital with mandibular fractures, and those who are fit for surgery under GA. The exclusion criteria is pregnancy and breastfeeding, renal and hepatic dosing, blood pressure, diabetic mellitus, autoimmune condition, patients consuming anti platelet drugs, anti coagulant drugs, anti convulsants,CNS depressants, seizure threshold lowering drugs, fluvoxamine, contraceptive drugs |