| 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
|
|
|
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
|
|
|
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-yamÄni
|
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-yamÄni (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. | |