| CTRI Number |
CTRI/2024/06/069452 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on treatment for Cervical Erosion with unani medicine |
|
Scientific Title of Study
|
Clinical study on Taakul e Unq ur Rahem (Cervical Erosion) and its management with Chui Mui (Mimosa Pudica) |
| 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 Humena Iffath Khatoon |
| Designation |
PG Scholar |
| Affiliation |
Kaloji Narayan Rao University of Health sciences |
| Address |
Room no-8,PG Department of Qabalat wa Amraz e Niswan, Government Nizamia Tibbi College and General Hospital,Charminar.
Hyderabad
TELANGANA
500002
India |
| Phone |
8106156714 |
| Fax |
|
| Email |
humenaiffath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahzadi Sultana |
| Designation |
HOD and Principal |
| Affiliation |
Kaloji Narayan Rao University of Health sciences |
| Address |
Room no-8,PG Department of Qabalat wa Amraz e Niswan,Government Nizamia Tibbi College and General Hospital,Charminar.
Hyderabad
TELANGANA
500002
India |
| Phone |
9908624090 |
| Fax |
|
| Email |
drssntc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Humena Iffath Khatoon |
| Designation |
PG Scholar |
| Affiliation |
Kaloji Narayan Rao University of Health sciences |
| Address |
Room no-8,PG Department of Qabalat wa Amraz e Niswan,Government Nizamia Tibbi College and General Hospital,Charminar.
Hyderabad
TELANGANA
500002
India |
| Phone |
8106156714 |
| Fax |
|
| Email |
humenaiffath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana, India, 500002 |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
Government Nizamia Tibbi College and General Hospital,Charminar,Hyderabad 500002 Telangana, India.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Humena Iffath Khatoon |
Government Nizamia Tibbi College and General Hospital |
Gynaec OPD Room No. 08, PG department of Qabalat wa amraz e Niswan
Hyderabad
TELANGANA |
8106156714
Humenaiffath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chui Mui (Mimosa pudica) |
15 gms, PO, BD in Arq form for 10 days of every cycle for maximum of 3 cycles.
Extract of Chui Mui in humool form for 10 days of every cycle after menstruation for maximum of 3 cycles
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
-Married women with different age group,parity and Socio economic status.
-Married women with sign and symptoms of Cervical Erosion. |
|
| ExclusionCriteria |
| Details |
-Pregnant Women.
-Doubtful or confirmed Malignancy.
-Uterine pathologies like fibroid,prolapse or endometritis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test the efficacy of mimosa pudica in the treatment of Cervical Erosion. |
10th day of each cycle for maximum 3 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resolution of cervical erosion |
10th day of each cycle for 3 cycles |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/06/2024 |
| 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="6"
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
|
A single blind clinical study on cervical erosion and its management with unani formulation Cervical Erosion is one of the most common benign gynaecological lesions of cervix. 3 out of 4 adult parous women suffer from this disease,with symptoms like Backache ,lower abdominal pain ,white discharge ,contact bleeding as the cervix becomes fragile and menstrual disorders like metrorrhagia dysmenorrhoea, menorrhagia, UTI, dyspareunia.Diagnosis: GENERAL EXAMINATION: Parous woman in childbearing age are common victims. General health may be poor, Slight anaemia is present. VAGINAL EXAMINATION: 1.Bimanual Examination 2.Speculum Examination Investigations include: 1.CBP 2.ESR 3.CUE 4.RBS 4.LFT 5.RFT SPECIAL INVESTIGATIONS: 1. VDRL 2.Cervical pap smear |