FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086480 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Curcumin on Inflammation, Pain, and Recovery Following Cesarean Section: A Double-Blind Randomized Trial 
Scientific Title of Study   Evaluation of the Effect of Curcumin on Inflammatory Markers, Pain, and Stress Response Following Cesarean Section: A Double-Blind, Randomized Placebo-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  CHARU 
Designation  JUNIOR RESIDENT 
Affiliation  M.L.B MEDICAL COLLEGE, JHANSI  
Address  Department of Anesthesia, OT block , Maharani Laxmi Bai Medical College ,

Jhansi
UTTAR PRADESH
284128
India 
Phone  08958291199  
Fax    
Email  char4u96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anshul Jain  
Designation  Professor  
Affiliation  M.L.B MEDICAL COLLEGE 
Address  Department of Anesthesia , OT Block , M.L.B. Medical College

Jhansi
UTTAR PRADESH
284128
India 
Phone  08958291199  
Fax    
Email  dranshuljain81@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anshul Jain  
Designation  Professor  
Affiliation  M.L.B MEDICAL COLLEGE 
Address  Department of Anesthesia , OT Block , M.L.B. Medical College


UTTAR PRADESH
284128
India 
Phone  08958291199  
Fax    
Email  dranshuljain81@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Maharani Laxmi Bai Medical College Jhansi 
Address  Department of Anesthesia OT Block M.L.B. College Jhansi 284128 Uttar Pradesh India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR CHARU  MLB MEDICAL COLLEGE JHANSI   Department of Anesthesia , OT Block , M.L.B. Medical College
Jhansi
UTTAR PRADESH 		 08958291199

char4u96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute ethical commitee m.l.b.medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80-O82||Encounter for delivery, (2) ICD-10 Condition: O80-O82||Encounter for delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcumin Drug Group   Drug: Curcumin (C3 Complex® 525 mg) + Piperine (Bioperine® 2.5 mg) Dose Schedule: First dose: Night before surgery (oral) Second dose: Morning of surgery (2-4 hours pre-op) Then: Twice daily for 3 days postoperatively  
Comparator Agent  Placebo group   Matching placebo capsule identical in appearance and schedule Dose Schedule: First dose: Night before surgery (oral) Second dose: Morning of surgery (2-4 hours pre-op) Then: Twice daily for 3 days postoperatively  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Undergoing elective cesarean section
ASA physical status II or III
Willing to give written informed consent
 
 
ExclusionCriteria 
Details  Pregnancy-induced hypertension (PIH)
Gestational or preexisting diabetes mellitus
Allergy to curcumin or piperine
Chronic analgesic or steroid use
Known bleeding or clotting disorder
Autoimmune or chronic inflammatory disorders
Active infection or clinical sepsis at time of enrollment
Planned or proposed vertical skin incision for cesarean delivery
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Change in inflammatory markers (IL-6, CRP, D-dimer) at baseline, 24h, and 72h post-op
2 Total postoperative analgesic requirement in the first 24h to maintain VAS less than 3
3 Wound healing score using the REEDA scale on postoperative Day 3 and Day 7
 		 24 hours , 72 hours , day 3 and day 7
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Total analgesic consumption over 72 hours
2 Pain Scores (VAS at 6h, 12h, 24h, 48h, & 72h)
3 Fatigue scores using 10-point interval rating scale (IRS) at 24h, 48h, Day 7
4 Maternal satisfaction using a 5-point Likert scale
5 Postoperative complications (e.g., fever, infection, delayed mobilization)
6 Length of hospital stay
7 Neonatal outcome assessed using Apgar scores at 1 & 5 minutes after delivery
 		 6 hours , 12 hours, 24 hours , 48 hours, 72 hours, day 7
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/05/2025 
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="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   The underlying study is being done for the Evaluation of the Effects of Curcumin on Inflammatory Markers, Pain, and Stress Response Following Cesarean Section. This is double blind , randomized placebo- controlled trial .
The participants are going to be divided into two groups . One group will be given the intervention and the other group will be given placebo  and also taken as control group . Both the groups will be followed and outcomes will be noted in terms of release of inflammatory markers , pain , stress response after cesarean section .

 
Close