| CTRI Number |
CTRI/2023/11/060358 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of Bacterial Vaginosis with Gule Dhawa |
|
Scientific Title of Study
|
Clinical Study of Bacterial Vaginosis(Jarasime Iltehabe Mehbal)and its Management with Gule Dhawa(Woodfordia Fruticosa) |
| 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 Rayees Unnisa |
| Designation |
Pg Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath Wa
Amraz e Niswan) Govt.Nizamia Tibbi College and General Hospital,Charminar.
Hyderabad
TELANGANA
500002
India |
| Phone |
8374253619 |
| Fax |
|
| Email |
rayeesunnisa910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahzadi Sultana |
| Designation |
Principal IC Nizamia Tibbi College and Hospital |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath Wa
Amraz e Niswan) Govt.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 Rayees Unnisa |
| Designation |
Pg Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath Wa
Amraz e Niswan) Govt.Nizamia Tibbi College and General Hospital,Charminar.
Hyderabad
TELANGANA
500002
India |
| Phone |
08374253619 |
| Fax |
|
| Email |
rayeesunnisa910@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 Qabalath wa Amraz e Niswan) |
| Address |
Government Nizamia Tibbi College and General Hospital Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath Wa
Amraz e Niswan)Charminar Hyderabad |
| 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 Department of Obstetrics and Gynaecology(Ilmul Qabalath 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 Rayees Unnisa |
Government Nizamia Tibbi College and General Hospital Charminar |
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath Wa
Amraz e Niswan)Government Nizamia Tibbi College and General Hospital charminar
Hyderabad
TELANGANA |
8374253619
rayeesunnisa910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt.Nizamia Tibbi College,Charminar,Hyderabad,Telangana State. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug: Gule Dhawa (Woodfordia Fruticosa)
Sufoof Dhawa and Roghane Neem |
Mode Of Usage: Oral and Hummoul
(Vaginal Suppository)
Oral: Decoction Of Gule Dhawa 10gm Per Day (15ml) Maximum Duration Of 60 Days Each Cycle For 10 Days
Hummoul (Vaginal Suppository): Sufoof Dhawa 3gm Along With Roghane Neem Its Internal Administration In Bacterial Vaginosis For 10 Days Follow UP For 2 Months With Internal Administration. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married patients between the age group 18 to 45 years
2.Complaining of vaginal discharge
3.Already diagnosed cases
|
|
| ExclusionCriteria |
| Details |
1.Patients presenting with blood-stained discharge
2.Pregnant lactating women
3.Trichomonas vaginitis candidiasis vaginitis
4.Patient with any organs pelvic pathology
5.Patient with systemic illness malignancy
6.Patients with AIDS, syphilis, Gonorrhoea
7.Patient with HTN, DM. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vaginal swab culture
|
Each Patient Outcome Depends on After 2 Cycles of Successful Oral Medicine ie 60days And Vaginal Suppository(HUMMOUL)Each Month 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Amsels criteria |
Each Patient Outcome Depends on After 2 Cycles of Successful Oral Medicine ie 60days And Vaginal Suppository(HUMMOUL)Each Month 10 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
08/12/2023 |
| 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
|
Bacterial vaginosis (BV) is a condition characterized by raised vaginal PH & MILKY white discharge in which the normal vaginal flora is replaced by mixed flora of aerobic anaerobic & microaerophilic species.  Bacterial Vaginosis is one of the common causes of vaginal discharge in the reproductive age group.  Non-specific vaginitis (NSV) also named bacterial vaginosis.  Bacterial vaginosis is termed vaginosis rather than vaginitis. It is associated with alternation in the normal vaginal flora rather than due to any infection. There is a considerable decrease in the number of lactobacilli in the vaginal discharge with 100 folds increase in the growth of other anaerobic Bacteria since lactobacilli release hydrogen peroxide toxic to other bacteria reduction in their number to allow other bacteria ie. aerobic & anaerobic bacteria to grow Therefore bacterial vaginosis is a polymicrobial condition.  The vagina is a fibromuscular membraneous sheath communicating the uterine cavity with the exterior at the vulva. it constitutes the excretory channel for the uterine secretion & menstrual blo od.  To evaluate the efficacy of Unani drugs in the cases of bacterial vaginosis  To determine the safe, easily available and cost-effective Unani drugs used in bacterial vaginosis. |