| CTRI Number |
CTRI/2024/04/065081 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Atorvastatin with Mifepristone in comparison to Mifepristone in medical management of fibroid |
|
Scientific Title of Study
|
Comparative Study Of Effect Of Atorvastatin With Mifepristone Versus Mifepristone In Medical Management Of Fibroid. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Goyal |
| Designation |
Junior Resident (MS Obstetrics and gynaecology) |
| Affiliation |
Teerthanker Mahaveer Medical college and Research Centre, Moradabad |
| Address |
Room no.121,Ist floor,OBGYN Department Teerthanker Mahaveer Medical college and Research Centre, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8198919454 |
| Fax |
|
| Email |
goyalriya1408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Rani |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical college and Research Centre, Moradabad |
| Address |
Room no.120,Ist floor,TMU Campus, Teerthanker Mahaveer Medical college and Research Centre, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9756216630 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Goyal |
| Designation |
JUNIOR RESIDENT (MS OBSTETRICS & GYNAECOLOGY) |
| Affiliation |
Teerthanker Mahaveer Medical college and Research Centre, Moradabad |
| Address |
Room no.121,Ist floor,Teerthanker Mahaveer Medical college and Research Centre, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8198919454 |
| Fax |
|
| Email |
goyalriya1408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research centre,Moradabad |
|
|
Primary Sponsor
|
| Name |
Dr Riya Goyal |
| Address |
OBGY Department Teerthanker Mahaveer Medical college and Health Centre,Moradabad |
| 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 Riya Goyal |
Teerthanker Mahaveer Medical College and Research Centre |
Room no.121,Ist floor,OBGYN Department Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH |
8198919454
goyalriya1408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeTMUMoradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atorvastatin with Mifepristone vs Mifepristone |
Two groups will be assigned, Group A and Group M.Group A will be given Tab Atorvastatin 20mg with Tab Mifepristone 25mg PER ORAL daily for 3 months.Group M will be given Tab Mifepristone 25mg PER ORAL daily for 3 months. |
| Comparator Agent |
Mifepristone |
Group M will be given Tab Mifepristone 25mg per oral daily for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients in reproductive and perimenopausal age group with uterine fibroid having symptom.patients giving written informed consent.Patients who donot want surgery. |
|
| ExclusionCriteria |
| Details |
Patients with severe presentation of fibroid such as severe intauterine bleeding or severe dysmenorrhea.Associated uterine and adnexal pathology like ovarian,cervical or uterine malignancy and associated medical morbidity like presence of liver disease,renal disease,myopathy,pancreatitis,hypersensitivity reaction and diabetes mellitus.patient necessitating early surgical intervention for uterine leiomyoma.Hormonal contraception or any hormonal therapy in the previous three months.Post menopausal women.Not willing to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of atorvastatin with mifepristone and mifepristone alone on the size of leiomyoma,endometrial thickness and pattern,dysmenorrhea,heavy menstrual bleeding and quality of life |
The following parameters are recorded at the start of the study and at the completion of three months.
USG(TVS/WA)
VAS
PBAC
QOL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroid |
The following parameters are recorded at the start of the study and at the completion of three months.
USG(TVS/WA)
VAS
PBAC
QOL |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/04/2024 |
| 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="3"
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
|
This study aims on the effectiveness of Atorvastatin with Mifepristone and mifepristone alone on the size of fibroid,endometrial thickness and pattern, dysmenorrhea,heavy menstrual bleed and quality of life. This study also aims on comparing the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroid and to note any side effect. |