| CTRI Number |
CTRI/2024/11/077424 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Vitamin E and omega 3 fatty acid in management of pain during menstruation |
|
Scientific Title of Study
|
Role of vitamin E and omega 3 fatty acid in management of dysmenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09756216630 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09756216630 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad |
| Address |
Department of Obstetrics and Gynaecology, Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09756216630 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh, 244001, India, |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centrea |
| Address |
Moradabad, Uttar Pradesh, 244001, India, |
| Type of Sponsor |
Private 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 Kanchan Rani |
Teerthanker Mahaveer Medical College |
Department of obstetrics and gynaecology, Gynaecology division, Room No. 18
Moradabad
UTTAR PRADESH |
09756216630
drkanchanrani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Teerthanker Mahaveer University, Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vitamin E and Omega 3 fatty acid |
400 IU of vitamin E and 600 mg of omega 3 fatty acid (EPA and DHA) to be given orally from 5 days before the start of menstruation for total of 8 days for 3 cycles |
| Comparator Agent |
Omega 3 fatty acid |
600 mg of omega 3 fatty acid (EPA and DHA) to be given from 5 days before the start of menstruation for total of 8 days for 3 cycles |
| Comparator Agent |
vitamin E |
400 IU of vitamin E to be given orally from 5 days before the start of menstruation for total of 8 days for 3 cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 18 to 45 years coming to Obstetrics and Gynaecology department with the diagnosis of dysmenorrhea |
|
| ExclusionCriteria |
| Details |
Patients with irregular menstrual cycles
Patients requiring immediate surgical management
Patients requiring immediate hormonal management
Patients with active PID
Patients with coagulopathy
Patients taking opioid analgesic
Patients on anticoagulants
Patients with liver disease
Patients with cardiac disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on average pain and maximum pain on VAS scale during menstruation in dysmenorrhea patients in 3 groups |
1 month, 2 months, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total number of NSAID tablets taken during menstruation in dysmenorrhea patients |
1 month, 2 months, 3 months |
| Effect on menstrual blood flow ( PBAC) in three groups |
1 month, 2 months, 3 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
09/12/2024 |
| 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="0"
Months="6"
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
|
We want to compare the effect of vitamin E and Omega 3 fatty acid on average and maximum pain during menstruation in dysmenorrhea patients. Participants will be enrolled after inclusion and exclusion criteria. Preintervention average pain and maximum pain during menstruation on VAS scale, average menstrual blood flow on PBAC chart and average number of NSAID tablets taken by patient for pain control during menstruation in the preceding last 3 menstrual cycle will be noted.. Participants will be randomized into 3 groups. Group A will receive 400 IU of vitamin E, group B will receive 600 mg of omega 3 fatty acid and group C will receive both 400 IU of vitamin E and 600 mg of omega 3 fatty acid orally starting from 5 days before the start of menstruation for a total of 8 days for 3 consecutive menstrual cycles. Postintervention following outcome will be assessed after 1st, 2nd and 3rd month - average and maximum pain during menstruation on VAS scale, menstruation blood flow on PBAC scale and total number of NSAID tablets taken by patient for pain during menstruation. Any side effects will be noted. appropriate statistical tests will be applied to compare the effects in 3 groups. |