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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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