| CTRI Number |
CTRI/2024/01/061204 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research on white discharge per vagina in unani medicine |
|
Scientific Title of Study
|
Effect of Rasaut in Bacterial vaginosis – A pre and post analysis study |
| 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 Najma Fathima |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6, Department of Ilmul Qabalath wa amraze
niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore KARNATAKA 560079 India |
| Phone |
8553403425 |
| Fax |
|
| Email |
najmafathima.nf67@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Principal |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6, Department of Ilmul Qabalath wa amraze
niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore KARNATAKA 560079 India |
| Phone |
9731628373 |
| Fax |
|
| Email |
drmanjulaprasad@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Najma Fathima |
| Designation |
PG Scholar |
| Affiliation |
overnment Unani Medical College and Hospital |
| Address |
Room no G6, Department of Ilmul Qabalath wa amraze
niswan,Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore KARNATAKA 560079 India |
| Phone |
8553403425 |
| Fax |
|
| Email |
najmafathima.nf67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College & Hospital Bangalore-560079 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College & Hospital Bangalore-560079 |
| Address |
Government Unani Medical College and Hospital Dr Siddaiah
Puranik Road, Basaveshwaranagar Bangalore-560079 |
| 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 Najma Fathima |
Government Unani Medical College and Hospital |
Room no G6,
Department of Ilmul
Qabalat was Amraze
niswan,Dr Siddaiah
Puranik Road,
Basaveshwaranagar Bangalore KARNATAKA |
8553403425
najmafathima.nf67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) for Biomedical Research Government Unani Medical College Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N760||Acute vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Humool(suppository) of rasaut |
In 5gms of Rasaut extract, Roghan-e-zaitoon and Liquid paraffin is added and made in suppository form and given to patient vaginally once at every night for 7 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women between 18-45 years of age with complaints of vaginal discharge associated with low backache and positive Amsel criteria. |
|
| ExclusionCriteria |
| Details |
Patients suffering from malignancies and STDs
History of recent antibiotic therapy.
Patients using OCPs and IUCDs.
Pregnant & lactating women.
Trichomoniasis, candidiasis, gonorrhoea and other types of vaginitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Amsel criteria |
Patients will be followed on 0 day, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in SF – 12 scale for QoL |
Patients will be followed on 0 day, 7th day and 14th day |
|
|
Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
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)
|
16/01/2024 |
| 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
|
|
Bacterial vaginosis (BV) is a polymicrobial syndrome having
alteration in the vaginal flora involving a decrease in Lactobacilli and
predominance of anaerobic bacteria such as Gardnerella vaginalis, Mobiluncus
species, Prevotella species, Mycoplasma hominis and Atopobium vaginae. BV
is the most common cause vaginal discharge in the reproductive aged women. Of
symptoms, a non-irritating, offensive fishy odor, homogenous white,
non-viscous vaginal discharge is characteristic. But it may not
always be present as at least 50% of the patients are asymptomatic. The
prevalence of BV differs widely from country to country within the same
region and even within similar population groups, it has been estimated to be
in the range of 8% to 75%. Maximum incidence of vaginal discharge
seen was in the age group of 20-29 years. BV was found
significantly more in married females as compared to unmarried, and in women with sexual transmitted infections (STIs), who have recently
changed their sex partner, multiple sexual partner, cigarette smoking,
stress, low socioeconomic status (SES), use of intra uterine device (IUCD),
frequent vaginal douches, early age at first intercourse and black ethnicity. Women with BV have increased risk of pelvic inflammatory disease (PID),
leading to infertility and abortions.
In conventional method, the first choice to treat reproductive
tract infections according to different pathogens is antibiotics. Most of the
drugs used are Metronidazole, Clotrimazole pessary and other antibiotics like
doxycycline and Ciprofloxacin which causes side effects and which are
effective temporarily, but the problem tends to recur once the medication is
stopped. Further, antimicrobial resistance is increased
rendering some regimen ineffective and the new agents are expensive. Thus,
there is a need of new formulations with fewer side effects.
In Unani concept and view the symptoms of BV is similar to that
of Saylan-al-Rahim and many drugs are available to treat Saylan-al-Rahim
in Unani system of Medicine. After reviewing the literature, it
has been decided to conduct a clinical study of Rasaut (Berberis aristata) on scientific parameters in patients with bacterial vaginosis.
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