| CTRI Number |
CTRI/2024/04/066106 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of centchroman (a contraceptive)and mefenamic acid (a pain killer) in premenstrual symptoms |
|
Scientific Title of Study
|
Effectiveness between centchroman vs mefenamic acid in premenstrual symptoms - A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha M |
| Designation |
Postgraduate, dept of obstetrics and gynaecology |
| Affiliation |
Sri manakula vinagayar medical college and hospital |
| Address |
No 68, department of obstetrics and gynaecology, SMVMCH
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9047036191 |
| Fax |
|
| Email |
varshamv98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Bupathy |
| Designation |
Professor, dept of obstetrics and gynaecology |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Room no 68, Department of obstetrics and gynecology, Sri manakula vinayagar medical college and hospital, Kalitheerthalkupam, Madagadipet, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8098250579 |
| Fax |
|
| Email |
arunabup@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Bupathy |
| Designation |
Professor, dept of obstetrics and gynaecology |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Room no 68, Department of obstetrics and gynecology, Sri manakula vinayagar medical college and hospital, Kalitheerthalkupam, Madagadipet, Puducherry
PONDICHERRY
605107
India |
| Phone |
8098250579 |
| Fax |
|
| Email |
arunabup@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Room no 68, Dept of Obstetrics and Gynecology, Sri manakula vinayagar medical College and hospital, Kalitheerthalkuppam, Madagadipet, Puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
Sri manakula vinayagar medical College and hospital |
| Address |
Kalitheerthalkuppam, Madagadipet, Puducherry 605107 |
| 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 Varsha M |
Sri manakula vinayagar medical College and hospital |
Room no 68, Dept of Obstetrics and Gynecology,
Sri Manakula Vinayagar Medical College and hospital, Kalitheerthalkuppam, Madagadipet, Puducherry
Pondicherry
PONDICHERRY |
9047036109
varshamv98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Centchroman |
60mg twice a week for 1 month followed by 60mg once a week for 1 month |
| Comparator Agent |
Mefenamic acid |
250 mg thrice daily give 5 days before menstruation till the relief of symptoms after menstruation |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Regular menses |
|
| ExclusionCriteria |
| Details |
Women with medical disorders, patients with breast lump , mammary ductal disease , fibrocystic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of centchroman and mefenamic acid in premenstrual symptoms (affective symptoms, mastalgia, premenstrual pain) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the improvement in quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Mefenamic acid is used traditionally for premenstrual symptoms. Premenstrual disorders results in loss of women hours of work, school, college and household works. PMS is more common among women and not much effective relief of symptoms in women has been seen.In this study the effectiveness of centchroman is studied with mefenamic acid as it is economical and a drug manufactured in India . |