| CTRI Number |
CTRI/2024/12/078540 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
efficacy of different doses of preoperative Melatonin on intraoprative blood loss and postoperative pain in patients undergoing cesarean section |
|
Scientific Title of Study
|
Efficacy of different doses of preoperative melatonin on intraoperative blood loss and postoperative pain in patients undergoing cesarean section : clinical academic 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 |
Trupti kamble |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalgiri Andhrapradesh |
| Address |
Obgy department ,Third floor AIIMS Mangalagiri Dist Guntur
Andhrapradesh India
OBG department 3rd floor AIIMS Mangalagiri Gutur Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8329799596 |
| Fax |
|
| Email |
drtruptik96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sairem Mangolnabi Chanu |
| Designation |
Associate professor |
| Affiliation |
AIIMS Mangalgiri Andhrapradesh |
| Address |
OBGY Department Third Floor AIIMS Mangalagiri Dist Guntur
Andhrapradesh India
OBG department 3rd floor AIIMS Mangalagiri Gutur Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8794713545 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.sairem mangolnabi Chanu |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalgiri Andhrapradesh |
| Address |
OBGY department Third floor AIIMS Mangalagiri Dist Guntur
Andhrapradesh India
OBG department 3rd floor AIIMS Mangalagiri Gutur Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8329799596 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Mangalgiri Andhrapradesh, India pincode 522503 |
|
|
Primary Sponsor
|
| Name |
Trupti kamble |
| Address |
AIIMS Mangalagiri Guntur Andhrapradesh India pincode 522503 |
| Type of Sponsor |
Other [Trupti Kamble] |
|
|
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 Trupti kamble |
AIIMS HOSPITAL MANGALGIRI |
3rd floor Obgy department AIIMS MANGALGIRI Dist Guntur Andhrapradesh PIN code 522503
Guntur
ANDHRA PRADESH |
8329799596
drtruptik96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee AIIMS Managalgiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
melatonin 6 mg |
melatonin 6 mg sublingual one dose given in patient undergoing section 30 min prior to spinal Aneshtesia |
| Intervention |
Melatonin drug |
3 mg melatonin by sublingual route to be given in women undergoing section 30 min before spinal only single dose |
| Comparator Agent |
vitamin B12 |
vitamin B12 1000mg sublingual one dose before spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Single cephalic term gestation pregnant women
|
|
| ExclusionCriteria |
| Details |
Allergy to melatonin
Twin gestation
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
decrease in blood loss
analgesic effect |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| analgesic effect & sleep quality |
analgesic effect 48 hrs after surgery
analgesic effect 72 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
10/02/2025 |
| 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="6"
Days="10" |
|
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 - Clinical Study Report
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [truptikamble1998@gmail.com].
- For how long will this data be available start date provided 06-05-2025 and end date provided 03-09-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
efficiency of diferent doses of melatonin on intraoprative blood loss and postoperative pain in patient undergoing cesarean section .will be assessing effect of different doses of melatonin on intraoprative blood loss and postoperative pain . studied have suggested that melatonin reduces risk of blood loss and postoperative pain . this also Induses sleep in patients ,so helpful in reducing anxiety also in postoperative period . this research will be for assessment of the same . |