| CTRI Number |
CTRI/2018/03/012668 [Registered on: 19/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of unani formulation in erosion of cervix |
|
Scientific Title of Study
|
Efficacy of a Unani formulation as topical application in Quruhal Rahim - An open labelled observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tooba Fahad |
| Designation |
PG Scholar OBG |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room no 1 girls hostel National Institute of Unani Medicine kottigepalaya magadi main road Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8123725543 |
| Fax |
|
| Email |
drtoobaf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ismath Shameem |
| Designation |
Lecturer |
| Affiliation |
National institute of unani medicine |
| Address |
Room no 3 department of obstetrics and gynecology national institute of unani medicine kottigepalaya magadi main road bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9538274583 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ismath Shameem |
| Designation |
Lecturer |
| Affiliation |
National institute of unani medicine |
| Address |
Room no 3 department of obstetrics and gynecology national institute of unani medicine kottigepalaya magadi main road bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9538274583 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of unani medicine kottigepalaya magadi main road bangalore |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine |
| Address |
Department of Obstetrics and gynecology national institute of unani
medicine kottiegepalaya magadi main road bangalore |
| 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 |
| Tooba Fahad |
National institute of unani medicine |
Department of
obstetrics and
gynecology room no 32
national institute of
unani medicine
bangalore
Bangalore
KARNATAKA |
8123725543
drtoobaf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with vaginal discharge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Murr, safaida, anzaroot, mom and roghane gul |
Murr, safaida, anzaroot will be taken in equal quantity finely powdered and ointment is prepared with mom and roghane gul 6 as per the method mentioned in literature 19 and 6 gms ointment will be applied with applicator per vaginum daily once at bedtime for 15 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married women in the age group 20- 40 yrs
Patients with cervical erosion on per speculum examination
Patients with vaginal discharge
Patients with normal or inflammatory changes in pap smear
|
|
| ExclusionCriteria |
| Details |
Patients with
premalignant or malignant changes in pap smear
Frank growth on the cervix
Pelvic inflammatory disease
OC Pills and IUCD’s
Systemic illnesses (UTI, TB, DM) & STD’s (Syphilis, HIV)
Pregnant & lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cervical erosion grading scale with three grades
|
Two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in vaginal discharge
and low back ache
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/01/2017 |
| Date of Study Completion (India) |
30/12/2017 |
| Date of First Enrollment (Global) |
25/01/2017 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical erosion is one of the commonest clinical entities seen in reproductive age group. An open observational study was carried out on 30 patients with vaginal discharge, low backache and cervical erosion on examination. Drugs Commiphora myrrha, lead carbonate, Astragalus sarcocola, bees wax and rose oil were given in the form of ointment for 14 days. The improvement in cervical erosion was credited to the anti inflammatory, anti oxidant, cytotoxic, anti microbial, sedative, hemostatic properties of research drug . |