| CTRI Number |
CTRI/2024/08/072215 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Optimal dose of centchroman in management of cyclical mastalgia |
|
Scientific Title of Study
|
A prospective clinical study to determine the therapeutic dose of Centchroman in the
manangement of cyclical mastalgia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmendra Tarkar |
| Designation |
Junior Resident |
| Affiliation |
UPUMS SAIFAI ETAWAH |
| Address |
Room no 226
Department of Surgery,
Old building , UPUMS, Saifai
Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7906265532 |
| Fax |
|
| Email |
dharmendratarkar@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somendra Pal Singh |
| Designation |
Professor |
| Affiliation |
UPUMS SAIFAI ETAWAH |
| Address |
Room no 226
Department of Surgery,
Old building , UPUMS, Saifai
Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7906265532 |
| Fax |
|
| Email |
somendrachauhan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmendra Tarkar |
| Designation |
junior resident |
| Affiliation |
UPUMS SAIFAI ETAWAH |
| Address |
Room no 226
Department of Surgery,
Old building , UPUMS, Saifai
Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7906265532 |
| Fax |
|
| Email |
dharmendratarkar@icloud.com |
|
|
Source of Monetary or Material Support
|
| Room no 226
Department of Surgery,
Old building , UPUMS, Saifai
Etawah 206130 , Uttar Pradesh , India |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Room no 226
Department of Surgery,
Old building , UPUMS, Saifai 206130, Uttar Pradesh , India
Etawah. |
| Type of Sponsor |
Government 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 Dharmendra Tarkar |
UPUMS saifai |
Surgery OPD UPUMS saifai Etawah
Etawah
UTTAR PRADESH |
7906265532
dharmendratarkar@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee of university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
centhroman in mastalgia |
Centchroman given at dose of 30mcg per oral thrice/week for 4 weeks followed by 2/week for next 4 weeks followed by 1/week for next 4 weeks. |
| Comparator Agent |
Placebo group |
Sweet candy tabs at 4 8 12 weeks in same manner as intervention group |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All women with mastalgia with VAS score ≥3 lasting for more than 5-7 days per cycle were included after signing a consent form. |
|
| ExclusionCriteria |
| Details |
• Patients with polycystic ovarian diseases and uterine cervical hyperplasia.
• First six months of Lactation and pregnancy
• Patients who were not giving consent.
• Past history of breast carcinoma or family history of breast carcinoma
• Patient who were planning for pregnancy .
• Women suspected or diagnosed of malignancy
• Recent history of jaundice or hepatic impairment.
• Severe allergic states.
• History of thrombosis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief from cyclical mastalgia. |
Outcome will be assessed at 4,8,12 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in fibroadenosis as well as reduction in size of fibroadenoma. |
Outcome will be assessed at 4,8,12 & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/08/2024 |
| 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="0"
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
|
Trial is still running and we have still not completed total no of participants |