| CTRI Number |
CTRI/2025/05/086317 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on birth control with unani formulation |
|
Scientific Title of Study
|
A Single Armed Single Centered Clinical Study On Efficacy Of Unani Formulation As Maane Hamal (contraceptive) |
| 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 Amatul Haseeb Aqiba |
| Designation |
PG scholar |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
Government nizamia tibbi college and general hospital
Opd room 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar hyderabad telangana 500002
Hyderabad
TELANGANA
500002
India |
| Phone |
8125332728 |
| Fax |
|
| Email |
dramatulhaseeb1236@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shahzadi Sultana |
| Designation |
HOD and PG professor |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
Government nizamia tibbi college and general hospital
Opd room 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar hyderabad telangana 500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9908624090 |
| Fax |
|
| Email |
drssntc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amatul Haseeb Aqiba |
| Designation |
Pg scholar |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
Government nizamia tibbi college and general hospital
Opd room 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar hyderabad telangana 500002
Hyderabad
TELANGANA
500002
India |
| Phone |
8125332728 |
| Fax |
|
| Email |
dramatulhaseeb1236@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government nizamia tibbi college and general hospital charminar hyderabad telangana 500002 |
|
|
Primary Sponsor
|
| Name |
Government nizamia tibbi college |
| Address |
Government nizamia tibbi college charminar hyderabad telangana |
| 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 Amatul Haseeb Aqiba |
Government nizamia tibbi college |
Opd room no 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar hyderabad telangana 500002
Hyderabad
TELANGANA |
8125332728
dramatulhaseeb1236@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z309||Encounter for contraceptive management, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habbe manae hamal will be given orally and habbul aas, mazo and roghan e gul given as pessary internally |
Patients will be subjected to habbe manae hamal orally and pessary vaginally.the intervention of habbe maane hamal will be started during menstruation 1.5grms (500milligrm tablets TID) daily for a period of 7days for 3 cycles.
Vaginal pessary will be started at 10th day of menses for a period of 10days for 3 cycles
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Age group 18-40yrs sexually active women
2,Multiparous,early married women
3)women who are willing to participate in the study
4)women having history of use of modern contraceptives
|
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women of six months
2)patients with confirmed malignant cases
3)patients effected with STDs
4)patients with complication of post delivery like menorrhagia,metrorrhagia
5)patients with amenorrhoea
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| CONTRACEPTION |
3 cycles during mensturation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
15/05/2025 |
| 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
|
| The population of India has been growing rapidly .world population is also a major problem with more than 6.3billion living on this Earth and 26 children born every second. The projected population of India in 2050 would be 1,705 million when India would be the most populous country exceeding China. One of the reason for growing population is limited use of CONTRACEPTIVES It’s a bitter truth That unani medicine is lacking in discussion on birth control or contraceptive method inspite of knowing writings of many unani physicians . keeping in view of today’s burning problem in India its seems our responsibility to make use of ancient literature in the widest interest of society. The need of birth control or contraceptive has arisen through increased cost of lIving, scarcity of accommodation , a desire for better education of children in the present competitive world. | Contraception is a process or technique for preventing pregnancy by means of Medication, Device or method that block or alters one or more of the processes of reproduction in such a way that sexual union can occur without impregnation. | Ideal contraceptive method should be highly effective( 100% ) ,acceptive;, ,safe, reversible ,cheap ,having non-contraceptive benefits,simple to use and requiring minimal motivation, maintenance and supervision | |