| CTRI Number |
CTRI/2024/08/072043 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heavy Menstural Bleeding and Mizaj in Reproductive age |
|
Scientific Title of Study
|
Relationship between Heavy Mentural Bleeding and Mizaj in reproductive age group A cross Sanctional 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 |
Dr A Suhasini |
| Designation |
Professor and HOD UG |
| Affiliation |
Government Nizamia Tibbi College and General Hopital |
| Address |
Department of Ilmul Qabalath Wa Amraz e Niswan
Govt Nizamia Tibbi College,Hyd,T.S.500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhaini12@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Suhasini |
| Designation |
Professor |
| Affiliation |
Govt. Nizamia General Hospital |
| Address |
Room No. 8, Gynec OPD,
Govt. Nizamia General Hospital,
Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Suhasini |
| Designation |
Professor |
| Affiliation |
Govt. Nizamia General Hospital |
| Address |
Room No. 8, Gynec OPD,
Govt. Nizamia General hospital,
Charminar, Hyderabad
Hyderabad
TELANGANA
560002
India |
| Phone |
09949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and Government Nizamia General Hospital,
Charminar, Hyderabad, Telangana State-500002, India |
|
|
Primary Sponsor
|
| Name |
Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad |
| Address |
Charminar, Hyderabad, Telangana-500002, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Suhaini |
Government Nizamia Tibbi College and General Hospital Charminar |
Dept of ILmul Qabalath Wa Amraz e Niswan
Govt Nizamia Tibbi College Charminar Hyderabad
Hyderabad
TELANGANA |
9949586899
drasuhaini12@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt.Nizamia Tibbi College,Charminar,Hyderabad,Telangana state. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women of Reproductive age between 18 to 45 year age.
Women with regular cycles 21 to 35 days with kathrat-e-hayd(heavy menstural bleeding) in duration more than 7 days or amount of flow greater than 80ml or both |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of chronic renal disease,liver disease,DM and endocrine disease(thyroid dysfunction)
Bleeding disorders, Severe Anaemia (Hb less than 7gm)
H/O hormonal contraceptives in last 3 months.
Pregnant and lactating mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment in Mizaj of kathrat-i-Hayd |
Only one visit at time of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="1"
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
|
An observational cross-sectional study of Relationship between Heavy Menstrual bleeding and Mizaj in reproductive age group-A cross sectional study by observing daily for 12 months in 86 patients that will be conducted in one center in india and the primary outcome measures will be Assesed the Mizaj in kathrat-i-Hayd with Alamate Ajnas Ashara for Mizaj .Assessment of PV heavy bleeding of every patient will be done by pictorial blood assessment chart in the form of scoring.Vitals will be recorded. General physical examination,local pelvic examination.The assessment of various Unani parameters will be carried out by the standard scales available for them and the correlation coefficient will be calculated between the obtained scores and the Mizaj assessment.Data will be collected in e-google form |