| CTRI Number |
CTRI/2024/11/076451 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| 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 the effect of unani formulation on infertility due to hormonal insufficiency
|
|
Scientific Title of Study
|
Single blind clinical study of uqr bawajah nuqs zamana e lautini (infertility due to luteal phases defect) and its management with halwa e suparipak. |
| 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 Sadaf Banu |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital charminar Hyderabad Telangana 500002 |
| Address |
OPD Room no 8
PG Department of Obstetrics and Gynaecology
Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9398831700 |
| Fax |
|
| Email |
sadafbanu108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
PG Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital charminar Hyderabad Telangana 500002 |
| Address |
OPD Room no 8
PG Department of Obstetrics and Gynaecology
Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
949202708 |
| Fax |
|
| Email |
syedaabidunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadaf Banu |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room no 8
PG Department of Obstetrics and Gynaecology
Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9398831700 |
| Fax |
|
| Email |
sadafbanu108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College charminar Hyderabad Telangana 500002 |
| 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 Sadaf Banu |
Government Nizamia Tibbi College |
OPD Room no 8 PG
Department of
Obstetrics &
Gynaecology
Government Nizamia
Tibbi College and
General hospital
Hyderabad
TELANGANA |
9398831700
sadafbanu108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Nizamia Tibbi College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N978||Female infertility of other origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Halwa E Suparipak |
Patients will be given oral medicine(Halwa e suparipak).20 gms with milk in two divided dose of 10gms in morning and 10gms in evening from D2 to D10 of cycle for 3 consicutive cycle, accordingly. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married Female with the age group between 20 to 40 years.
Female in the reproductive age group with at least one year of normal sexual life.
Females of primary infertility as well as secondary infertility, and secondary infertility associated with first trimester abortion.
Females with infertility due to Luteal Phase Defect associated with immature follicles, hyperprolactenemia and ovulation, anovulation,oligo- ovulation.
Patient willing to participate in the trial and signing the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Females with the congenital defects or anatomical abnormalities of the genital organs.
Females with diagnosed case of tubal block.
Females with Known case of DM.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conception |
1 week after missed periods |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sr progesterone levels |
Every 3rd week of menstrual cycle for 3 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
13/11/2024 |
| 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
|
TITLE: SINGLE BLIND CLINICAL STUDY OF UQR BAWAJAH NUQS ZAMANA E LAUTINI ( INFERTILITY DUE TO LUTEAL PHASE DEFECT) AND ITS MANAGEMENT WITH HALWA E SUPARIPAK.
AIM: To assess the efficacy of the unani formulation in infertility due to luteal phase Defect.
OBJECTIVES: To provide safe and easily available unani formulation having minimal or no adverse effects To eleminate the cause of infertility due to luteal phase Defect STUDY DESIGN: Single blind,single centre, single arm clinical study.
SAMPLE SIZE: 38
PLACE OF STUDY: OPD room 8 of Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 Duration of Treatment: 3 menstrual cycle consecutively, accordingly. INTERVENTION: Oral medicine 20gms in 2 divided dose of 10 gms in morning and evening from D2 of cycle to D10 of cycle . PRIMARY OUTCOME: Conception SECONDARY OUTCOME: sr progesterone levels
|