| CTRI Number |
CTRI/2024/02/062521 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
Effect of Dracaena Cinnabari (Dam-ul- Aqwain)on Menstrual Flow in Menorrhagia-A Randomized Control Clinical 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 Khujasta Jabeen |
| Designation |
Pg Scholar |
| Affiliation |
Govt. Nizamia Tibbi College And General Hospital |
| Address |
Pg Departmemt of Obstetrics and Gynaecology (Ilmul Qabalat Wa Amraz-E-Niswan),Charminar,Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9515621825 |
| Fax |
|
| Email |
jabeenomar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
Professor |
| Affiliation |
Govt. Nizamia Tibbi College And General Hospital |
| Address |
Pg Departmemt of Obstetrics and Gynaecology (Ilmul Qabalat Wa Amraz-E-Niswan),Charminar,Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabidunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khujasta Jabeen |
| Designation |
Pg Scholar |
| Affiliation |
Govt. Nizamia Tibbi College And General Hospital |
| Address |
Pg Departmemt of Obstetrics and Gynaecology (Ilmul Qabalat Wa Amraz-E-Niswan),Charminar,Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9515621825 |
| Fax |
|
| Email |
jabeenomar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad |
|
|
Primary Sponsor
|
| Name |
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalat Wa Amraz-E- Niswan) |
| Address |
Government Nizamia Tibbi College and General Hospital Pg Departmemt of Obstetrics and Gynaecology (Ilmul Qabalat Wa Amraz-E-Niswan),Charminar. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government Nizamia Tibbi College and General Hospital Charminar |
Government Nizamia Tibbi College and General Hospital Pg Departmemt of Obstetrics and Gynaecology (Ilmul Qabalat Wa Amraz-E-Niswan),Charminar,Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khujasta Jabeen |
Government Nizamia Tibbi College and General Hospital |
PG DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY (ILMUL QABALATH WA AMRAAZ NISWAN)Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad
TELANGANA |
9515621825
jabeenomar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committte |
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, (2) ICD-10 Condition: N925||Other specified irregular menstruation, (3) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dracaena Cinnabari(Dam-ul-Aqwain) |
Oral administration of Dam-ul-aqwain sufoof 1gm twice a day for 5 days |
| Comparator Agent |
Tranexamic acid 5oomg |
Tab.Tranexamic acid 500 mg twice a day to be consumed for five days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Excessive bleeding moreover than 80ml
2.Both married Nulliparous multiparous) unmarried.
3.Fibroid (less than 3cm),anovulatory,unknown etiology.
4.Thyroid disorders.
Patient willing to comply various demand of study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with HTN,DM
2.Significant Cardiovascular/pulmonary,Hepato-renal dysfunction.
3.Hematological disorders
4.Attained menopause
5.Known causes of immune-compromised state(AIDS/Malignancies,Auto immune disease) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pictorial Blood Picture Chart. |
Amount of Blood Loss in Each Menstrual Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual Blood Flow is Decreased/Stopped |
Each Patients Outcome Depends on Consumption of Interventions for 5 days BD |
|
|
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 3 |
|
Date of First Enrollment (India)
|
17/02/2024 |
| 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 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
|
- In Menorrhagia regularly timed episodes of bleeding that are excessive in amount greater than 80ml and or duration of flow greater than 7 days
- Menorrhagia interferes with female physical emotional social and quality of life , which can occur alone or in combination with other symptoms
- This period is associated with endocrine hormonal changes leading to menstrual disorders especially Menorrhagia
- Bleeding greater than usual days, quantity increased than previous cycle , passing blood clots, tiredness, fatigue are observed as clinical features
- Complications may generalised weakness Severe anemia , ascites , liver dysfunction
|