| CTRI Number |
CTRI/2025/03/083396 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICACY OF ORAL ORMELOXIFENE VERSUS VITAMIN E ON MASTALGIA |
|
Scientific Title of Study
|
EFFICACY OF ORAL ORMELOXIFENE VERSUS VITAMIN E ON MASTALGIA: AN OPEN LABEL RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhilasha |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no 10 ; Department of general surgery Aarupadai Veedu Medical College and Hospital, Kirummmpakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7428785253 |
| Fax |
|
| Email |
abhilasha.anita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhu |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no 10 ; Department of general surgery Aarupadai Veedu Medical College and Hospital, Kirummmpakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9787422020 |
| Fax |
|
| Email |
prabhu.surgeon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhu |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no 10 ; Department of general surgery Aarupadai Veedu Medical College and Hospital, Kirummmpakkam, Pondicherry
PONDICHERRY
607402
India |
| Phone |
9787422020 |
| Fax |
|
| Email |
prabhu.surgeon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 10
C block
Department of General Surgery
Aarupadai Veedu Medical College
Kirumampakkam
Pondicherry
607402
India |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
Room number 10
C block
Department of General Surgery
Aarupadai Veedu Medical College
Kirumampakkam
Pondicherry
607402
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 |
| Abhilasha |
Aarupadai veedu medical college and hospital |
Room number 10
C block
Department of General Surgery
Aarupadai Veedu Medical College
Kirumampakkam
Pondicherry
607402
India
Pondicherry
PONDICHERRY |
7428785253
abhilasha.anita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E35||Disorders of endocrine glands in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ormeloxifene |
Ormeloxifene 30mg was given to patients on alternate days for 3 months |
| Intervention |
Vitamin E |
Vitamin E was given to patients 400mg daily dosing for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Para 1 or above, non-desirous of pregnancy in recent future |
|
| ExclusionCriteria |
| Details |
Multiple fibroadenomas, breast abscess, pregnancy, liver disease, cervical dysplasia, breast carcinoma, patients desirous of pregnancy in near future |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess reduction in VAS score in mastalgia patients in both groups |
Patient’s assessment done at baseline, at 4 weeks, at 8 weeks, at 12 weeks and at 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the side effects of Ormeloxifene & Vitamin E |
At baseline, at 4 weeks, at 8 weeks, at 12 weeks & at 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/04/2025 |
| 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="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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [abhilasha.anita@gmail.com].
- For how long will this data be available start date provided 01-04-2025 and end date provided 01-04-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After getting approval from IRC and IEC, patients coming to
General Surgery OPD with Mastalgia during the duration of study will be
filtered as per inclusion and exclusion criteria. Patients will be informed about
the study details, its nature and purpose, and will be assured their
non-participation will not hamper their treatment. Informed consent will be taken
from the willing participant. Patients’ identities and their responses will be
kept confidential.
Random sampling of the selected group will be conducted
through a computer generated program, dividing patients into two groups.
All demographic details of the patient and their VAS score
at presentation will be recorded in a especially designed proforma.
Basic investigations like CBC, LFT will be done. USG of
breast will be done to rule out multiple fibroadenomas or to see excess
nodularity. USG abdomen to rule out PCOS and liver pathologies.
Group A patients will be given Ormeloxifene tablets, 30 mg
on alternate days for 3 months.
Group B will be given Vitamin E 400mg daily for 3 months
Patients will be followed up at 1st week to
assess tolerance to drugs and subsequently at 4, 8, 12 and 24 weeks to assess
pain relief and reduction in nodularity.
They will be asked to keep a daily breast pain chart. And pain
relief at each visit will be quantified according to the VAS scale.
QoL assessment will be done ata each visit
Data will be tabulated, analyzed based on statistical tests
Results obtained and conclusions will be drawn
|