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CTRI Number  CTRI/2025/02/080007 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Unani formulation versus metronidazole in leucorrhoea due to bacterial vaginosis- A randomized controlled trial 
Scientific Title of Study   Effect of vaginal application of Unani formulation versus metronidazole in leucorrhoea due to bacterial vaginosis- A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaikh Zaiba Afroz Alam 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  OPD no 29,dep lImul Qabalat wa Amraze Niswan National Institute of Unani Medicine, Kottegepalya, Magadi main road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9664786273  
Fax    
Email  zebashaikh0097@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ismath Shameem 
Designation  Professor and HoD  
Affiliation  National Institute of Unani Medicine 
Address  OPD NO 29,dept Ilmul qabalat wa amraze niswan,National Institute of Unani Medicine, Kottegepalya, Magadi main road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Ismath Shameem 
Designation  Professor and HoD  
Affiliation  National Institute of Unani Medicine 
Address  OPD no 29, dept Ilmul qabalt wa amraze niswan, National Institute of Unani Medicine, Kottegepalya, Magadi main road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine Kottegepalya magadi main road,bangalore karnataka 560091 . 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottegepalya, Magadi main road, Bangalore 560091 
Type of Sponsor  Research institution and hospital 
 
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 Shaikh Zaiba Afroz Alam  National Institute of Unani Medicine,  OPD No 29, Ilmul Qabalat wa Amraz e Niswan National Institute of Unani Medicine, kottegepalya, magadi main road Bangalore KARNATAKA 560091
Bangalore
KARNATAKA 
9664786273

zebashaikh0097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Unani Medicine, Bangalore communication of decision of the institutional ethics committee (ICE) for biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Metronidazole 400 mg   Tablet Metronidazole 400 mg twice daily will be administered orally for 5 days after meals 
Intervention  Unani formulation (Mazu Rasaut Kundur Samaq and Shibb-i-yamani   hamul (5g) will be prepared & prescribed for per vaginal use once daily at bed time for 14 days. 
Intervention  Unani formulation (Mazu Rasaut Kundur Samaq and Shibb-i-yamāni   Gel will be prepared from the same Unani formulation and prescribed for per vaginal use once daily at bed time for 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Married women in age group of 18-45 years presenting with complain of offensive vaginal discharge, pruritus vulvae, pelvic pain. Study participants with Positive Amsels criteria (more than equal to 3 out of 4) and Nugent score (b/w 4-7 with p/o clue cells and more than equal to 7 irrespective of clue cells).
 
 
ExclusionCriteria 
Details  Uncontrolled systemic diseases (DM, HTN, TD), malignancy, pelvic pathology(21)
Trichomoniasis and candidiasis (excluded based on microscopy and characteristic of discharge)(6,15)
Gonorrhoea and other types of vaginitis(16,20,21)
OCPs and IUCD(20)
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Nugent score  baseline,14th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Amsels criteria  baseline & 14th day 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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/ Phase 3 
Date of First Enrollment (India)   16/02/2025 
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="6"
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 polymicrobial syndrome characterized by a shift in the composition of the vaginal microbiota from ‘optimal’ to ‘non-optimal’ This non-optimal microbiological state involves a reduction in protective lactobacilli, and an increase in bacterial diversity and facultative and strict anaerobes, including Gardnerella spp., Atopobium vaginae, Prevotella spp., and others, referred to as BV-associated bacteria (BVAB).(1) Although the prevalence of bacterial vaginosis 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%. Bacterial vaginosis can occur in any age group, but globally it is more prevalent in females of reproductive age.(2)  BV is associated with pelvic inflammatory disease, STIs, and risk for human immunodeficiency virus (HIV) infection and transmission.(1–3) BV infection in pregnancy has a poor perinatal outcome, in particular an increased risk of preterm birth, premature rupture of amniotic membranes (PROM) and chorioamnionitis.(4)The number of behavioral and socioeconomic risk factors are cigarette smoking, douching, multiple sexual partners, use of sex toys and sharing of them within the women, use of intrauterine devices (IUD) contraception, drug abuse, early age intercourse, black ethnicity, oral sex, sexually transmitted diseases (STDs) or immune deficiency disorders like HIV, HSV-1 and 2, infection with C. trachomatis, N. gonorrhoeae).(1,2,5,6)

In conventional medicine, metronidazole and clindamycin are the 1st line of treatment.(1,2) Despite the fact that women with BV who get seven days of oral metronidazole (MTZ) have cure rates of about 80% after 30 days, the majority of BV cases reappear after a year. Recurrent BV is defined as ≥3 annual episodes of symptomatic BV requiring antimicrobial therapy (3), which has negative impact on patient emotionally, sexually and socially, impairing their quality of life and causing significant economic burden on health care system. (16) In addition it has many side effects, such as toxicity, hypersensitivity reactions, drug resistance, superinfection etc. Therefore, the need for traditional system of medicine arises to reduce the disease incidence, complications and recurrence with least side effects and cost effective treatment.(1)

In Unani system of medicine, many single drugs and compound formulations are available for the treatment of bacterial vaginosis. One such compound formulation include Mazu (Quercus infectoria Oliv), Rasaut (Berberis volgare DC), Kundur (Boswellia serrata Roxb), Samaq (Rhus coriaria L) and Shibb-i-yamāni (Alum)(11) possessing the property of Habis (styptic), Qabid (astringent), Radi‘ (repellent), Dafi‘-i-Jarathim (anti-bacterial), Mujaffif (desiccant) etc.(7) Hence, the present study has been designed to validate the efficacy of aforementioned formulation on scientific parameters in patient with leucorrhoea due to bacterial vaginosis.

 
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